Kader, et al v. Sarepta Therapeutics, Inc., et al

Filing

OPINION issued by Juan R. Torruella, Appellate Judge; William J. Kayatta, Jr., Appellate Judge and David J. Barron, Appellate Judge. Published. [17-1139]

Case: 17-1139

Document: 00117273866

Page: 1

Date Filed: 04/04/2018

Entry ID: 6161202

United States Court of Appeals
For the First Circuit
No. 17-1139
WILLIAM KADER, individually and on behalf of all
others similarly situated; MORAD GHODOOSHIM;
ROGER LAM; LAXMIKANT CHUDASAMA,
Plaintiffs, Appellants,
v.
SAREPTA THERAPEUTICS, INC.; CHRISTOPHER GARABEDIAN;
EDWARD M. KAYE, M.D.,
Defendants, Appellees.

APPEAL FROM THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF MASSACHUSETTS
[Hon. Allison D. Burroughs, U.S. District Judge]

Before
Torruella, Kayatta, and Barron,
Circuit Judges.

Kara M. Wolke, with whom Robert V. Prongay, Jonathan M.
Rotter, Glancy Prongay & Murray LLP, Jason M. Leviton and Block &
Leviton LLP were on brief, for appellants.
Christopher
G.
Green,
with
whom
Mark
D.
Vaughn,
Christopher C. Boots, Cassandra A. LaRussa and Ropes & Gray LLP
were on brief, for appellees.

April 4, 2018

Case: 17-1139

Document: 00117273866

Page: 2

TORRUELLA, Circuit Judge.
Lead

Plaintiffs

Morad

Ghodooshim,

Date Filed: 04/04/2018

Entry ID: 6161202

Plaintiff William Kader and
Roger

Lam,

and

Laxmikant

Chudasama (collectively, the "Plaintiffs") sought to represent a
class of purchasers of securities that Sarepta Therapeutics, Inc.
("Sarepta") issued between April 21, 2014, and October 27, 2014
(the "Class Period").
claims

against

Christopher

The Plaintiffs brought securities fraud

Sarepta,

Garabedian

Sarepta's

Chief

("Garabedian"),

Executive

and

Officer,

Sarepta's

Chief

Scientific Officer, Edward M. Kaye ("Kaye") (collectively, the
"Defendants").

According

to

the

Plaintiffs,

the

Defendants

knowingly or recklessly misled investors about their target date
for submitting an application to the United States Food and Drug
Administration ("FDA") for approval of the drug eteplirsen.

The

district court dismissed the Plaintiffs' First Amended Complaint
("FAC") for failure to state a claim, and then denied them leave
to file their Proposed Second Amended Complaint ("PSAC").

We hold

that the district court did not err in dismissing the FAC or in
denying Plaintiffs leave to file the PSAC.
I.

BACKGROUND

A. The FDA's drug-approval process
Before we immerse ourselves in the details of this case,
it is useful to give a brief overview of the process through which
the FDA reviews and approves drugs.

-2-

That process begins when the

Case: 17-1139

Document: 00117273866

Page: 3

Date Filed: 04/04/2018

Entry ID: 6161202

sponsor of a new drug submits a New Drug Application ("NDA") to
the

FDA.

See

21

U.S.C.

§

355(a)-(b);

Corban

v.

Sarepta

Therapeutics, Inc., 868 F.3d 31, 34 (1st Cir. 2017) (outlining the
FDA's approval process).

The FDA then makes the "threshold

determination" as to whether the NDA is "sufficiently complete to
permit a substantive review."

21 C.F.R. § 314.101(a)(1).

"If so,

the FDA accepts the application for filing" and then proceeds to
"assess[] the merits of the application, deciding whether to
approve the drug."
§ 314.101(a)(1),

Corban, 868 F.3d at 34 (citing 21 C.F.R.

(f)).

"Approval

generally

requires

the

application's sponsor to demonstrate the drug's clinical benefit."
Id. (citing 21 U.S.C. § 355(d)).
Sponsors

of

certain

drugs

may

avail

themselves

various FDA programs that expedite the review process.

of

These

programs aim to facilitate the availability of critical therapies
for serious, unmet medical needs.

For example, upon a sponsor's

showing of adequate preclinical data, the FDA may grant a drug
"Fast Track" status.

See 21 U.S.C. § 356(b).

Among other

benefits, the sponsors of "Fast Tracked" drugs may interact more
frequently with the FDA to discuss "the drug's development plan
and ensure collection of appropriate data needed to support drug
approval."

U.S.

Food

&

Drug

-3-

Admin.,

Fast

Track,

https://

Case: 17-1139

Document: 00117273866

Page: 4

Date Filed: 04/04/2018

Entry ID: 6161202

www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm

(last

updated Jan. 4, 2018).
Fast Tracked drugs may also be eligible for "Accelerated
Approval."

Id.

The

FDA

approves

drugs

in

the

Accelerated

Approval program upon meeting a "surrogate endpoint" or "clinical
endpoint"

that

is

clinical benefit.

"reasonably

likely"

21 U.S.C. § 356(c).

to

predict

the

drug's

"For example, instead of

having to wait to learn if a drug actually extends survival for
cancer patients, the FDA may approve a drug based on evidence that
the drug shrinks tumors, because tumor shrinkage is considered
reasonably likely to predict a real clinical benefit."
&

Drug

Admin.,

Accelerated

Approval,

ForPatients/Approvals/Fast/ucm405447.htm
2018).

U.S. Food

https://www.fda.gov/

(last

updated

Jan.

4,

This is particularly useful in the case of drugs intended

to treat diseases with longer courses, when measuring the drug's
clinical benefit would otherwise require an extended period of
time.

In such cases, the drug's effect on the surrogate or

clinical endpoint may be observable much sooner, allowing the FDA
to determine the drug's efficacy at an earlier juncture.
Crucially, once the FDA has approved a drug, the drug's
sponsor may begin to market it.

-4-

Case: 17-1139

Document: 00117273866

Page: 5

Date Filed: 04/04/2018

Entry ID: 6161202

B. The facts underlying this case
Except when we indicate otherwise, we draw the following
facts from the FAC.
1.
Duchenne Muscular Dystrophy ("DMD") is a rare genetic
neuromuscular disorder that primarily affects boys and young men.
As the result of inadequate production of the protein dystrophin,
individuals with DMD suffer from progressive muscle loss causing
severe

disability

and

premature

death.

The

average

expectancy for someone diagnosed with DMD is 27 years.

life

During the

Class Period, no approved disease-modifying therapies for DMD
existed.

Sarepta, however, was developing drug candidates to

treat DMD, including eteplirsen, the drug around which this case
revolves.

See Corban, 868 F.3d at 34-37 (describing, in the

context of a case involving a different class period, Sarepta's
development of eteplirsen).

During the Class Period, Sarepta's

main competitor, Prosensa Therapeutics, Inc., was also developing
and seeking approval of a drug candidate to treat DMD.

The first

company to obtain approval of its drug and succeed in bringing it
to

market

would

obtain

the

"first

mover

advantage."

In

pharmaceutical markets, the "first mover" gains a considerable
advantage

because

doctors

will

quickly

prescribe

the

first

available drug of a new type, and are unlikely to switch to

-5-

Case: 17-1139

Document: 00117273866

Page: 6

Date Filed: 04/04/2018

Entry ID: 6161202

prescribing a different drug of the same type that subsequently
becomes available.
The FDA granted eteplirsen Fast Track status in 2007. In
2011, Sarepta began conducting the clinical trials at the center
of this case.

Study 201, designed as a randomized, double-blind,

placebo-controlled study involving 12 participants, sought to
assess the effects of "eteplirsen administered intravenously in
two different doses over 24 weeks for the treatment of ambulant
boys with DMD."

The study's participants all underwent muscle

biopsies at the study's outset and conclusion to determine if the
amount of dystrophin in their muscle tissue had changed over time
-- a potential surrogate endpoint by which to assess eteplirsen's
efficacy.
eteplirsen

Study
met

the

201's

results

primary

showed

efficacy

that

endpoint

"treatment
in

the

with

study."

Following these encouraging results, Sarepta began "Study 202," in
which the same participants received varying dosages of eteplirsen
for an additional 24 weeks.

All of the muscle biopsy dystrophin

analysis for both of these studies took place at a single location
-- Nationwide Children's Hospital in Columbus, Ohio -- with one
doctor overseeing the entirety of the clinical review.

Because

this analysis requires staining muscle samples with a dye that
makes dystrophin visible, and then viewing and analyzing those

-6-

Case: 17-1139

Document: 00117273866

Page: 7

Date Filed: 04/04/2018

Entry ID: 6161202

samples in slides, the Plaintiffs aver that it is "inherently
subjective."
2.
On April 21, 2014 -- the first day of the Class Period
-- Sarepta issued a press release discussing the possibility of
submitting an NDA for eteplirsen by the year's end.

According to

the press release, that goal was "based on a guidance letter from
the [FDA] that proposed a strategy regarding the submission of an
NDA

for

pathway."

eteplirsen

under

a

potential

Accelerated

Approval

The press release quoted the FDA's guidance letter,

which explained that "with additional data to support the efficacy
and safety of eteplirsen for the treatment of DMD, an NDA should
be fileable."

The press release also explained that the FDA's

letter "outlined examples of additional data and analysis that, if
positive, will be important to enhance the acceptability of an NDA
filing by addressing areas of ongoing concern in the existing
dataset."

In

addition,

"expressed

concerns

the

about

release

noted

methodological

that

the

problems

FDA

had

in

the

assessments of dystrophin and, 'remain[s] skeptical about the
persuasiveness of the (dystrophin) data.'"

According to the press

release, the FDA had stated that, as a result, it was "uncertain
whether the existing dystrophin biomarker data will be persuasive

-7-

Case: 17-1139

Document: 00117273866

Page: 8

Date Filed: 04/04/2018

Entry ID: 6161202

enough to serve as a surrogate endpoint that is reasonably likely
to predict clinical benefit."
That same day, Sarepta held a conference call with
investors and analysts to discuss its announcement.

Per the

guidance letter, Garabedian explained that with "additional data
and analysis," Sarepta would be able to "pursue an NDA filing that
we will plan to submit by the end of this year, for a potential
early

approval

of

eteplirsen

sometime

in

2015."

But,

he

cautioned, "the guidance letter described the FDA's reservations
that the existing data set may not be sufficient to support an NDA
filing,

or

be

compelling

enough

for

a

favorable

review."

Garabedian further offered that "[w]e could submit our NDA now on
the existing data set, but the FDA has highlighted questions and
concerns," for which reason "we are going to be in a much better
position if we just wait for some of these additional pieces of
data."
Following this announcement, Sarepta shares increased in
value by 39.26% on unusually heavy trading volume, closing on
April 21, 2014 at $33.98 per share.

The following day, Sarepta

announced that it planned to offer up to $100 million of its common
stock in a public offering.

Then, on April 29, it sold 2,650,000

shares of common stock in a public offering at a price of $38.00

-8-

Case: 17-1139

per

Document: 00117273866

share,

resulting

in

Page: 9

net

Date Filed: 04/04/2018

proceeds

of

Entry ID: 6161202

approximately

$94.5

million.
On

May

7,

2014,

Garabedian

conference call with analysts.
the

FDA's

guidance

letter

participated

in

another

During that call, he characterized
as

communicating

to

Sarepta,

in

paraphrased terms:
[W]e're not telling you you can't submit an NDA
tomorrow on the existing data set . . . . But we're
telling you that we've raised enough concerns on the
existing data set that you would bolster your case
for an NDA filing and potentially a favorable review
if you allow us to do a more detailed review of your
dystrophin methodology [and if you supplement the data
set].
In short, Sarepta expressly disclosed that the FDA wanted to do a
more detailed review of the study's methodology, and get more data,
and that Sarepta's chances of success for an NDA filing would be
affected by whether it allowed the FDA to do so.

Additionally,

during the same month, the FDA also visited Nationwide Children's
Hospital -- where Study 201/202 took place -- to review the
clinical trial site and protocols in place there.
Then,

on

July

29,

2014,

the

FDA

requested

that

"independent pathologists at independent labs" review Sarepta's
primary

dystrophin

endpoint.

Sarepta

did

not

request to the public during the class period.

disclose

this

On the same day,

the director of the FDA's Center for Drug Evaluation and Research
("CDER") responded via a statement on the White House's website to
-9-

Case: 17-1139

Document: 00117273866

Page: 10

Date Filed: 04/04/2018

Entry ID: 6161202

a petition urging the FDA to "say YES to Accelerated Approval for
safe,

effective

therapies

for

children

with

Duchenne."

Her

response acknowledged Sarepta's intention of filing an NDA for
eteplirsen by the end of 2014.
On August 7, 2014, Garabedian held another conference
call with investors and analysts.

During that call, he stated

that "[a]s a reminder, the FDA indicated in its April guidance
that if, after further detailed review, they were to find the
currently available dystrophin biomarker data to be adequate, our
existing dystrophin data set would have the potential to support
accelerated approval."

After relaying that the FDA had visited

National Children's Hospital, he added that "we continue to work
with the FDA to provide greater assurance of the quality and
reliability of our dystrophin data in anticipation of a potential
NDA filing decision and potential NDA review next year."
However, on October 27, 2014 -- the last day of the Class
Period -- Sarepta issued another press release announcing that it
had received updated guidance from the FDA regarding its planned
NDA submission for eteplirsen.
FDA

now

required

Sarepta's

That guidance indicated that the
NDA

to

include

additional

data,

including, among other things, "the results from an independent
assessment of dystrophin images and the 168-week clinical data
from study 202."

As a result, the press release explained, Sarepta

-10-

Case: 17-1139

Document: 00117273866

Page: 11

Date Filed: 04/04/2018

Entry ID: 6161202

would not be able to submit an NDA until mid-2015, as opposed to
its prior target of late 2014.

On the same day, Sarepta executives

also held a conference call with investors and analysts to convey
and explain the FDA's concerns.

That day, Sarepta shares declined

by more than 32%, closing at $15.91 per share, on unusually heavy
trading volume.
On October 30, 2014, the FDA issued a public statement
addressing "questions the agency has received from DMD patients,
their families, and others in the community who are concerned about
the timing of the filing of an NDA for eteplirsen."

The statement

underscored that "[i]n its advice to Sarepta, FDA has consistently
stated that it would be necessary to include data in its NDA
demonstrating that eteplirsen increases production of the muscle
protein dystrophin."

The statement also clarified that during the

FDA's visit to Nationwide Children's Hospital, "the agency did not
find any evidence of fraud at this site, as has been perceived by
some."

However, the FDA also highlighted its concern "that the

methods used to measure dystrophin were not adequately robust to
support an NDA submission."

Finally, the statement concluded by

explaining that the "FDA will continue to work with Sarepta in
their efforts to provide the data it considers critical to FDA's
ability to review the NDA and reach a decision on approvability."

-11-

Case: 17-1139

Document: 00117273866

Page: 12

Date Filed: 04/04/2018

Entry ID: 6161202

3.
We add the following facts from the PSAC.
In

May

2015,

after

the

Plaintiffs

brought

this

securities fraud suit, see infra Section I.C., Sarepta did file an
NDA for eteplirsen.
August 25, 2015.

The FDA accepted the NDA for filing on

While the director of the CDER has the sole

authority to approve an NDA, the FDA may call upon advisory
committees to provide independent opinions and recommendations
during the approval process.

The FDA scheduled an advisory

committee meeting about the eteplirsen NDA for January 22, 2016.
In anticipation of that meeting, the FDA published a briefing
document for members of the advisory committee (the "Briefing
Document").

That document detailed, among other things, the

concerns that the FDA had communicated to Sarepta prior to and
during the Class Period.
So

too,

primarily

for

purposes

of

narrative

completeness, do we mention the following facts contained neither
in the FAC nor the PSAC.
The

district

court

took

judicial

notice

that,

on

September 19, 2016 -- after briefing on the Plaintiffs' motion for
leave to amend had concluded, see infra Section I.C. -- the FDA
announced that it had decided to grant accelerated approval to
eteplirsen.

Moreover, the Plaintiffs ask us to take judicial

-12-

Case: 17-1139

Document: 00117273866

Page: 13

Date Filed: 04/04/2018

Entry ID: 6161202

notice that this announcement came after an appeal within the FDA
to the CDER director's initial decision to grant accelerated
approval to eteplirsen.

In brief, the Director of CDER's Office

of Drug Evaluation brought an appeal challenging that decision on
the basis that Study 201/202 was methodologically inadequate.
After reviewing the appeal, the FDA Commissioner decided to "defer
to [the CDER director's] judgment and authority to make the
decision to approve eteplirsen under the accelerated approval
pathway."1

Thus, Sarepta was able to begin marketing eteplirsen.

C. This putative class action
The Plaintiffs filed the FAC on March 20, 2015, alleging
two counts: (1) that all of the Defendants violated section 10(b)
of the Securities Exchange Act of 1934 (the "Exchange Act"), see
15 U.S.C. § 78j(b), and Securities and Exchange Commission ("SEC")
Rule 10b-5, see 17 C.F.R. § 240.10b-5, and (2) that Garabedian and
Kaye violated section 20(a) of the Exchange Act.

In broad terms,

the Plaintiffs alleged that the Defendants, in discussing their
intention to file an NDA in 2014, fraudulently misrepresented the
FDA's communications to them concerning Sarepta's dystrophin data.

1

We note that, while we have made reference to these facts, which
were not before the district court, they do not end up having the
effect of impacting our analysis.
-13-

Case: 17-1139

Document: 00117273866

Page: 14

Date Filed: 04/04/2018

Entry ID: 6161202

The Defendants moved to dismiss the FAC for failure to
state a claim.

See Fed. R. Civ. P. 12(b)(6).

granted that motion on April 5, 2016.
did

not

allege

"sufficient

facts

The district court

It concluded that the FAC

to

plausibly

suggest

that

Defendants made affirmatively misleading statements, or that they
omitted . . . information needed to make their statements not
misleading."

It also held that the FAC similarly lacked facts

supporting an inference of scienter on the part of Sarepta's
executives as to the allegedly misleading nature of any of their
statements or omissions.
The Plaintiffs then filed a motion for leave to amend
the FAC, attaching the PSAC to that motion.

The PSAC, unlike the

FAC, contained allegations involving the Briefing Document.

The

Briefing Document, according to the Plaintiffs, demonstrated that
the FDA had communicated to Sarepta a "plethora of concerns" about
Sarepta's data before and during the Class Period.

It also, said

the Plaintiffs, illustrated that the Defendants had misrepresented
Study 201/202 as "blinded."
On

January

6,

2017,

the

Plaintiffs' motion for leave to amend.

district

court

denied

the

Specifically, it held that

the Plaintiffs had delayed unduly in moving to amend, and that, in
any event, the PSAC was futile because it also failed to state a
claim.

The Plaintiffs now appeal the district court's orders

-14-

Case: 17-1139

Document: 00117273866

Page: 15

Date Filed: 04/04/2018

Entry ID: 6161202

denying them leave to file the PSAC and dismissing their claims
with prejudice.
II.

THE DISTRICT COURT PROPERLY DISMISSED THE FAC

We first take up the Plaintiffs' contention that the
district court erred in dismissing the FAC for failure to state a
claim.

Our review of a district court's dismissal under Rule

12(b)(6) is de novo.

Schaefer v. Indymac Mortg. Servs., 731 F.3d

98, 103 (1st Cir. 2013).

In determining whether the FAC stated a

claim upon which relief can be granted, "we accept well-pleaded
factual

allegations

in

the

complaint

as

true

reasonable inferences in the plaintiffs' favor."

and

view

all

ACA Fin. Guar.

Corp. v. Advest, Inc., 512 F.3d 46, 58 (1st Cir. 2008).
A. The relevant law
To survive a motion to dismiss under Rule 12(b)(6), a
complaint alleging securities fraud under section 10(b) of the
Exchange Act and Securities and Exchange Commission Rule 10b–5
must plead six elements: "(1) a material misrepresentation or
omission;

(2)

scienter,

or

a

wrongful

state

of

mind;

(3)

a

connection with the purchase or sale of a security; (4) reliance;
(5) economic loss; and (6) loss causation."

Id. at 58.

Only the

first two elements are at issue here.2

2

While the Plaintiffs also brought claims under section 20(a),
those claims are "derivative of 10b-5 claims." Hill v. Gozani,
638 F.3d 40, 53 (1st Cir. 2011).
Following a finding that a
-15-

Case: 17-1139

Document: 00117273866

Page: 16

Date Filed: 04/04/2018

Entry ID: 6161202

The Private Securities Litigation Reform Act of 1995
("PSLRA"),

15

U.S.C.

securities

fraud

pleadings.

With regard to misleading representations, the PSLRA

and

§

78u-4,

imposes

a

governs

complaints

particularity

alleging

requirement

on

requires that complaints "specify each statement alleged to have
been misleading [and] the reason or reasons why the statement is
misleading."

Id. § 78u-4(b)(1)(B); see also Aldridge v. A.T.

Cross Corp., 284 F.3d 72, 78 (1st Cir. 2002).

As for scienter,

the PSLRA requires that complaints "state with particularity facts
giving rise to a strong inference that the defendant acted with
the required state of mind."
added).

15 U.S.C. § 78u-4(b)(2)(A) (emphasis

To satisfy this "rigorous" requirement, Advest, Inc., 512

F.3d at 58, a plaintiff must "show either that the defendants
consciously intended to defraud, or that they acted with a high
degree of recklessness," Aldridge, 284 F.3d at 82 (citing Greebel
v. FTP Software, Inc., 194 F.3d 185, 198-201 (1st Cir. 1999)).
Additionally, the Supreme Court has determined that under the
PSLRA, "an inference of scienter must be more than merely plausible
or reasonable -- it must be cogent and at least as compelling as

company has violated a substantive section of the Exchange Act,
section 20(a) imposes joint and several liability on that company's
executives unless they "acted in good faith and did not directly
or indirectly induce the act or acts constituting the violation or
cause of action." 15 U.S.C. § 78t(a).
-16-

Case: 17-1139

Document: 00117273866

Page: 17

Date Filed: 04/04/2018

any opposing inference of nonfraudulent intent."

Entry ID: 6161202

Tellabs, Inc.

v. Makor Issues & Rights, Ltd., 551 U.S. 308, 314 (2007); see also
Advest, Inc., 512 F.3d at 59 ("[W]here there are equally strong
inferences for and against scienter, Tellabs now awards the draw
to the plaintiff.").
B. Material misrepresentations or omissions
In dismissing the FAC, the district court first held
that the complaint failed "to plead any facts plausibly suggesting
that Defendants' statements or omissions were materially false or
misleading."

On appeal, the Plaintiffs argue that the district

court was wrong for two reasons:
public

statement

supports

the

(1) the FDA's October 30, 2014
inference

that

the

Defendants

"recklessly misrepresented" their ability to file an NDA by the
end of 2014, and (2) after receiving a request for independent
review of its dystrophin data in July 2014, and failing to comply
with that request, the Defendants misled investors by continuing
to represent that a 2014 NDA submission was possible and by failing
to disclose that request and the noncompliance with it.

We take

these arguments in turn.
1.
To begin, we disagree with the Plaintiffs that the FDA's
October 30 public statement suggests that the FDA had previously
communicated anything to Sarepta (such as, that its data were

-17-

Case: 17-1139

Document: 00117273866

Page: 18

Date Filed: 04/04/2018

Entry ID: 6161202

inadequate) that would render misleading the Defendants' continued
representations that a 2014 NDA submission was possible.

That

inference would not be reasonable. Contrary to what the Plaintiffs
insist, the FDA did not appear to make its October 30 statement
with the purpose of correcting any prior misrepresentations by
Sarepta.

Rather, the statement explicitly purported to "address[]

questions

the

agency

has

received

from

DMD

patients,

their

families, and others in the community who are concerned about the
timing of the filing of an NDA for eteplirsen."
It is true that the statement highlighted that: (1) "[i]n
its advice to Sarepta, FDA has consistently stated that it would
be

necessary

to

include

data

in

its

NDA

demonstrating

that

eteplirsen increases production of . . . dystrophin"; (2) "the
need for additional data and analyses to support the NDA was
reinforced

by

an

FDA

inspection

of

the

clinical

site

where

dystrophin analyses had been conducted"; and (3) after the site
visit, the FDA had "provided Sarepta with detailed recommendations
on how to improve these dystrophin analyses, and FDA's most recent
advice was consistent with the advice provided after the April
2014 meeting."

But none of this supports the inference that the

FDA had previously told Sarepta that its data were categorically
inadequate. And crucially, the statement also recognized Sarepta's
April

2014

announcement

of

its

"plans

-18-

to

submit

an

NDA

for

Case: 17-1139

Document: 00117273866

eteplirsen

by

the

end

of

Page: 19

2014,"

Date Filed: 04/04/2018

without

Entry ID: 6161202

objecting

to

otherwise characterizing it as misleading or unfounded.

it

or

So, the

FDA's statement cannot serve as the scaffolding for any reasonable
inference that the FDA had communicated anything to Sarepta during
the

Class

Period

that

would

make

the

Defendants'

subsequent

representations about filing an NDA in 2014 misleading.
2.
The Plaintiffs next turn their focus to the July request
for independent review, which was not itself disclosed as such.
The Plaintiffs' theory is that once Sarepta received this request,
it knew it could not reasonably expect to file an NDA until the
requested independent review was completed, and it knew that it
was not acceding to the request.

As a result, the Plaintiffs say,

its continued assertion on the August 7 call that its existing
dataset could support accelerated approval was misleading.
To

advance

this

argument,

Plaintiffs

would

have

us

assume that the July request for independent review was materially
different in its potential impact on the likelihood of approval
than was the FDA's April request for further review (which had
been disclosed to investors).

For purposes of our disposition of

this appeal, we can make that assumption.

In so doing, however,

we cannot avoid observing that it is hardly obvious that the July
request for independent review was significantly new and that

-19-

Case: 17-1139

Document: 00117273866

Page: 20

Date Filed: 04/04/2018

Entry ID: 6161202

compliance with it was more mandatory than what had come before.
Both before and after the July request, it was the case that the
FDA was saying that further review by someone other than Sarepta
would affect the chances of approval, which is precisely what
Sarepta disclosed.
C. Scienter
The

Plaintiffs'

pursue

two

lines

of

argumentation

regarding scienter: (1) that "concealing and avoiding the requests
for reassessment recklessly risked misleading investors"; and (2)
that Sarepta's significant motive to mislead investors is an
indicia of scienter.3
1.
Keeping in mind that inferences of scienter under the
PSLRA must be "at least as compelling as any opposing inference of
nonfraudulent intent," Tellabs, 551 U.S. at 314, we begin with the
first of Plaintiffs' arguments.

As the district court correctly

noted, given that it is the only communication that took place
after the FDA made this request, Garabedian's August 7, 2014 phone
call with investors is the only communication we need to look at.4

3

The Plaintiffs also argue that Garabedian's evasive response to
a question during his May 7 conference call indicated that he was
knowingly misleading investors regarding the FDA's July request
for independent review. But this cannot be right, because according
to the Plaintiffs, the FDA had not yet made that request.
4

In

their

reply

brief,

the

Plaintiffs

-20-

argue

that

various

Case: 17-1139

Document: 00117273866

Page: 21

Date Filed: 04/04/2018

Entry ID: 6161202

In analyzing that call, we also keep in mind our recognition that
providing warnings to investors, or otherwise disclosing potential
risks, erodes inferences of scienter.

See Fire & Police Pension

Ass'n of Colo. v. Abiomed, Inc., 778 F.3d 228, 244 (1st Cir. 2015)
(holding that defendants' informative disclosures "undercut any
inference of scienter"); City of Dearborn Heights Act 345 Police
& Fire Ret. Sys. v. Walters Corp., 632 F.3d 751, 760 (1st Cir.
2011) ("[A]ttempts to provide investors with warnings of risks
generally

weaken

the

inference

of

scienter."

(alteration

in

original) (quoting Ezra Charitable Tr. v. Tyco Int'l, Ltd., 466
F.3d 1, 8 (1st Cir. 2006))).
The substance of what Garabedian communicated during the
August 7 phone call severely weakens any inference of scienter.
He told investors "[a]s a reminder, the FDA indicated in its April
guidance that if, after further detailed review, they were to find
the currently available . . . data to be adequate, our existing
dystrophin data set would have the potential to support accelerated
approval."

He further explained that Sarepta was "continu[ing]

to work with the FDA to provide greater assurance of the quality

statements by the Defendants in April and May of 2014 were
misleading in light of the FDA's July request for independent
review. But, this argument necessarily fails because, according to
the FAC, these phone calls took place before the FDA communicated
that request to Sarepta.
-21-

Case: 17-1139

and

Document: 00117273866

reliability

of

our

Page: 22

Date Filed: 04/04/2018

dystrophin

data."

In

this

Entry ID: 6161202

manner,

Garabedian reminded investors that the FDA was looking for further
review, as Sarepta disclosed in April. At the same time, Garabedian
gave no assurance that Sarepta would accede to the type of review
that the FDA sought.

As we have discussed, the difference between

those statements and what exactly happened is not obvious, as
investors knew that Sarepta's chances would be less if it did not
receive a further review.

And even accepting the Plaintiffs'

position that there was a material difference nonetheless, it was
not such that one might reasonably infer scienter from Sarepta's
failure to elaborate more fully on any difference between a review
by the FDA and a review for the FDA by another lab.
words,

an

arguable

misrepresentation

provides

by

In other

itself

less

support for an inference of scienter than does a clear falsehood.
See Flannery v. SEC, 810 F.3d 1, 9 (1st Cir. 2015) ("If it is
questionable whether a fact is material or its materiality is
marginal, that tends to undercut the argument that defendants acted
with the requisite intent or extreme recklessness in not disclosing
the fact." (quoting City of Dearborn Heights, 632 F.3d at 757)).
We now turn to the Plaintiffs' related argument that
Garabedian recklessly risked misleading investors about Sarepta's
likelihood of achieving that result by failing to mention that
Sarepta was not complying with the FDA's request for independent

-22-

Case: 17-1139

review.

Document: 00117273866

Page: 23

Date Filed: 04/04/2018

Entry ID: 6161202

As we have noted, unlike in its October 2014 guidance,

the FDA did not describe compliance with its July 29, 2014 request
as a mandatory prerequisite for a successful NDA filing.

And as

we have previously held, when defendants do not divulge the details
of interim "regulatory back-and-forth" with the FDA, that alone
cannot support an inference of scienter under the PSLRA when the
defendants do provide warnings in broader terms.
Inc., 778 F.3d at 243-44.

See Abiomed,

"There must be some room for give and

take between a regulated entity and its regulator."

Id. at 244;

see also Corban, 868 F.3d at 40 ("The defendants had no legal
obligation

to

loop

the

public

into

each

detail

of

every

communication with the FDA.").
Additionally, we understand the Plaintiffs' arguments
about Sarepta's failure to obtain independent review to assert
that Sarepta was avoiding doing so out of concern that its data
would not hold up under scrutiny.5

Thus, the argument that the

Defendants needed to disclose that they had not followed this
request is a variation on the Plaintiffs' other arguments that the
Defendants were not forthcoming about the FDA's concerns about

5

The Plaintiffs do not, for example, argue that Sarepta avoided
complying with this request because it would be costly, or time
consuming, or for any other reason unrelated to the risk that
independent experts would not be able to confirm the studies'
results.
-23-

Case: 17-1139

Document: 00117273866

Page: 24

Date Filed: 04/04/2018

Entry ID: 6161202

their data's reliability or that they misleadingly claimed that
they had strong data.

And we note again that Garabedian admitted

during the August 7 phone call that the FDA had such concerns about
Sarepta's

data.

So,

even

if

Garabedian

made

material

misrepresentations or omissions regarding the July request for
independent review or Sarepta's compliance with it, the inference
that he did so with scienter is not sufficiently compelling under
Tellabs for purposes of stating a claim for securities fraud.
2.
The Defendants' purported motive to deceive investors
similarly

fails

to

make

an

inference

of

scienter

adequately

compelling. Pointing to Sarepta's public offering during the Class
Period, the Plaintiffs insist that "[i]n a race for FDA approval
and generating no significant revenue, Sarepta was dependent upon
offerings to fund its operations; reporting positive news was
critical to Sarepta's existence."
arguments of this sort.

We have set a high bar for

Indeed, "catch-all allegations that

defendants stood to benefit from wrongdoing" are not enough.
Greebel, 194 F.3d at 197 (quoting In re Advanta Corp. Sec. Litig.,
180 F.3d 525, 535 (3d Cir. 1999)).

Rather, "[w]e require something

more than the ever-present desire to improve results, such as
allegations that 'the very survival of the company w[as] on the
line.'"

Corban 868 F.3d at 41 (second alteration in original)

-24-

Case: 17-1139

Document: 00117273866

Page: 25

Date Filed: 04/04/2018

Entry ID: 6161202

(quoting In re Cabletron Sys. Inc., 311 F.3d 11, 39 (1st Cir.
2002)).
The Plaintiffs do not clear this bar.

The FAC is bereft

of allegations that Sarepta was financially on the ropes, or that
it "would shutter its doors unless it padded earnings by deceiving
investors."

Corban, 868 F.3d at 42.

It may be so that this

offering generated revenue that proved useful to Sarepta in its
"race for FDA approval," so to secure the "first-mover advantage."
Yet, that alone cannot bear the weight of an inference of scienter
that is "at least as compelling" as any other.

Tellabs, 551 U.S.

at 314.
Therefore, because the Plaintiffs did not adequately
plead scienter in the FAC, we hold that district court did not err
in dismissing the FAC for failure to state a claim.
III.

THE DISTRICT COURT PROPERLY DENIED LEAVE TO AMEND
We

now

turn

to

the

Plaintiffs'

arguments

that

the

district court should have granted them leave under Fed. R. Civ.
P. 15(a) to file the PSAC.

The district court denied leave on the

grounds that the Plaintiffs had moved to amend with "undue delay"
and because, in any event, the PSAC also failed to state a claim.
On appeal, the Plaintiffs urge the opposite: that they did not
delay unduly and that the PSAC did state a claim.

We assume

(without deciding) that the PSAC was not futile, but nonetheless

-25-

Case: 17-1139

Document: 00117273866

Page: 26

Date Filed: 04/04/2018

Entry ID: 6161202

affirm the district court's denial of leave to amend on undue delay
grounds.
Under Fed. R. Civ. P. 15(a)(2), a party may amend a
pleading "with the court's leave."

The Rule further provides that

"[t]he court should freely give leave when justice so requires."
Nonetheless, grounds for denying leave include "undue delay, bad
faith

or

dilatory

motive

.

.

.

repeated

failure

to

cure

deficiencies by amendments previously allowed, undue prejudice to
the opposing party . . . [and] futility of amendment."

Advest,

Inc., 512 F.3d at 55-56 (quoting Forman v. Davis, 371 U.S. 178,
182 (1962)).

While "[t]he rule reflects a liberal amendment

policy . . . the district court enjoys significant latitude in
deciding whether to grant leave to amend."
omitted).

Id. at 55 (citation

And notably, "undue delay in moving to amend, even

standing alone," can provide a court with adequate grounds to deny
leave.

Zullo v. Lombardo (In re Lombardo), 755 F.3d 1, 3 (1st

Cir. 2014).
We have previously made the observation that "the longer
a plaintiff delays, the more likely [a] motion to amend will be
denied."

Advest, Inc., 512 F.3d at 57 (citing Steir v. Girl Scouts

of the USA, 383 F.3d 7, 12 (1st Cir. 2004)).

And we have

explicitly condemned a "wait and see" approach to pleading, whereby
plaintiffs "having the needed information, deliberately wait in

-26-

Case: 17-1139

Document: 00117273866

Page: 27

Date Filed: 04/04/2018

Entry ID: 6161202

the wings . . . with another amendment to a complaint should the
court hold the first amended complaint was insufficient."

Id.

The Plaintiffs filed the FAC on March 20, 2015.

The

Briefing Document -- the source of the Plaintiffs' new allegations
in the PSAC -- became available in January 2016.
court denied the FAC on April 5, 2016.

The district

Three days later, the

Plaintiffs moved to file the PSAC.
The PSAC differed from the FAC in two key respects.
First, it alleged that the FDA had requested an independent review
of Sarepta's dystrophin data in July 2013 (a year earlier than the
FAC claimed that this occurred).

Second, it alleged that Sarepta

had manipulated its dystrophin studies, and that the FDA had
communicated concerns to Sarepta that "the blinded nature of the
dystrophin

study

had

been

improperly

broken

after

initial

(blinded) analysis failed to yield positive results."

Thus,

according to the PSAC, the Defendants "misrepresented that the
dystrophin

analysis

controlled

manner,

was

conducted

and

they

in

a

properly

misrepresented,

blinded
omitted,

and
and

recklessly ignored the FDA's repeated guidance to seek independent
laboratory verification of the dystrophin assessment results."
Highlighting

the

three-month

gap

between

the

FDA's

publication of the Briefing Document and the Plaintiffs' motion to
amend, the district court reasoned that "[t]he timing of the filing

-27-

Case: 17-1139

Document: 00117273866

Page: 28

Date Filed: 04/04/2018

Entry ID: 6161202

of the motion to amend suggests that rather than moving promptly
for

leave

to

file

a

new

complaint

based

on

new

information

discovered in January 2016, the Plaintiffs instead waited for the
Court's ruling on the Motion to Dismiss before seeking leave to
amend."

This, it concluded, amounted to "wait and see" pleading,

and thus undue delay.
The district court did not abuse its discretion in
reaching

this

conclusion.

The

Plaintiffs'

arguments

to

the

contrary focus on their subjective belief in the strength of the
FAC and on minimizing the three months during which they could
have moved for leave to amend.

We are unmoved by the Plaintiffs'

arguments concerning their belief that the FAC adequately stated
a claim. Regardless of whether or not they intentionally sandbagged
their claims, the fact remains that despite having three months to
do so, the Plaintiffs did not move to amend until after the
district court dismissed the FAC.

And while the Plaintiffs

characterize this period of time as "relatively short," we have
previously upheld denials of leave to amend on undue delay grounds
after a comparable amount of time.

See Villanueva v. United

States, 662 F.3d 124, 127 (1st Cir. 2011) (affirming a finding of
undue delay where the plaintiff moved to amend four months after
filing his complaint); Kaye v. New Hampshire, 821 F.2d 31, 34 (1st

-28-

Case: 17-1139

Document: 00117273866

Page: 29

Date Filed: 04/04/2018

Entry ID: 6161202

Cir. 1987) (per curiam) (finding a three-month delay to be a
sufficient basis for denying leave to amend).
We also reject the Plaintiffs' argument that moving to
amend post-dismissal is desirable from the perspective of judicial
economy.

They press that "it would have been neither practical

nor economical to move to amend the complaint each time new
relevant information was released while dispositive motions were
pending in this case . . . especially in the context of [the]
dynamic

factual

process."
methodology
work."

developments

surrounding

the

[FDA

approval]

But the Plaintiffs "have it exactly backwards -- their
would

lead

to

delays,

inefficiencies,

Advest, Inc., 512 F.3d at 57.

and

wasted

Indeed, the resulting

"unnecessary costs and inefficiencies on both the courts and party
opponents" is precisely the reason why we refused to sanction a
"wait and see" approach to pleading in Advest.

Id.

It may be so

that the Plaintiffs did not move to amend at an earlier juncture
because they believed that further information relevant to their
claims

may

have

been

coming

down

consideration of the eteplirsen NDA.

the

pike

amid

the

FDA's

But that is not so much an

argument against the district court's denial of their motion for
leave to amend as it is a suggestion that the Plaintiffs perhaps
jumped the gun in filing the FAC.

-29-

Accordingly, we conclude that

Case: 17-1139

Document: 00117273866

Page: 30

Date Filed: 04/04/2018

Entry ID: 6161202

the district court did not abuse its discretion in denying leave
to amend on undue delay grounds.6
IV.

CONCLUSION

The FAC failed to state a claim, and even assuming that
the PSAC did not also suffer from that deficiency, the district
court did not abuse its discretion in ruling that the Plaintiffs
moved to file it with undue delay.

Therefore, the district court's

judgment is affirmed.
Affirmed.

6

While both of the PSAC's new claims -- that the FDA had requested
independent review in July 2013 and that Sarepta had fraudulently
characterized its dystrophin studies as blinded -- derived from
the Briefing Document, the PSAC also cited the transcript from the
hearing before the district court in Corban, during which a portion
of the FDA's July 2013 written guidance to Sarepta (requesting
that Sarepta confirm its data independently) was read into the
record. Because this hearing took place in August 2015, however,
this does not impact our conclusion that the district court did
not abuse its discretion in denying leave to amend.
-30-