In re: Amarin Corporation PLC

Filing

NOT PRECEDENTIAL OPINION Coram: SMITH, Chief Judge, MCKEE and RENDELL, Circuit Judges. Total Pages: 18. Judge: RENDELL Authoring.

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NOT PRECEDENTIAL
UNITED STATES COURT OF APPEALS
FOR THE THIRD CIRCUIT

No. 16-2640

IN RE: AMARIN CORPORATION PLC SECURITIES LITIGATION

James L. Reiss, Lead Plaintiff on behalf of all plaintiffs,
Appellants

On Appeal from the United States District Court
for the District of New Jersey
(D.N.J. No.: 3-13-cv-06663)
District Judge: Honorable Freda L. Wolfson

Argued on April 25, 2017
Before: SMITH, Chief Judge, MCKEE and RENDELL, Circuit Judges

(Opinion filed: May 23, 2017)

Robert C. Finkel
[ARGUED]
Lester L. Levy
Sean M. Zaroogian
Wolf Popper
845 Third Avenue, 12th Floor
New York, NY 10022
Jeffrey W. Herrmann
Cohn Lifland Pearlman Herrmann & Knopf
Park 80 West - Plaza One
250 Pehle Avenue, Suite 401
Saddle Brook, NJ 07663
Counsel for Appellants

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Christina L. Costley
Bruce G. Vanyo
Katten Muchin Rosenman
2029 Century Park East, Suite 2600
Los Angeles, CA 90067
Howard R. Rubin [ARGUED]
Robert T. Smith
Katten Muchin Rosenman
2900 K Street, N.W.
Suite 200, North Tower
Washington, DC 20007
Jason C. Vigna
Katten Muchin Rosenman
575 Madison Avenue, 11th Floor
New York, NY 10022
Counsel for Appellees

OPINION*

RENDELL, Circuit Judge:
Appellant-Plaintiff James Reiss (the “Plaintiff”) appeals an Order of the District
Court dismissing his putative securities fraud class action complaint (the “Second
Consolidated and Amended Class Action Complaint” or “SAC”) against the AppelleeDefendant Amarin Plc., a biopharmaceutical corporation, and certain of its individual
officers (the “Defendants”). The District Court held that the Plaintiff failed to state a
claim because none of the eighty-seven statements made by the Defendants and

*

This disposition is not an opinion of the full Court and pursuant to I.O.P. 5.7
does not constitute binding precedent.
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recounted in the SAC were false or misleading. For the reasons that follow, we agree
with the District Court’s reasoning and will affirm.
I. BACKGROUND
A. Factual Background
Amarin’s primary drug is Vascepa, an ultra-pure omega-3 fatty acid product
designed to reduce triglycerides in the blood stream. Triglycerides (“TGs”) are a common
form of fat molecule. During the Class Period (November 29, 2010 through October 16,
2013), the Defendants sought FDA approval of Vascepa for treatment of patients with
elevated TGs who are already taking a statin drug like Lipitor (the “ANCHOR
Indication”). The Defendants theorized that administering Vascepa in this regime would
result in a statistically significant reduction of major adverse cardiac events like heart
attacks. They have vigorously pursued ANCHOR because the potential treatment
population is thirty-six million people.1
To support its application for the ANCHOR Indication, Amarin proposed
conducting a 12-week trial (the “ANCHOR Study”) to demonstrate the efficacy of the
drug. Given its short duration, the ANCHOR Study could not measure cardiovascular
outcomes directly as the clinical endpoint of the study. Such a measurement would
require an expensive and time-consuming long-term outcomes study. Rather, Amarin

1

Amarin secured FDA approval of Vascepa for another indication, the MARINE
indication, to treat persons with “very high” TGs at risk of pancreatitis. But this
population contained approximately four million potential patients.
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proposed to rely on the reduction of TGs as a “surrogate endpoint,” on the assumption
that a significant reduction of TGs would lead to reduced major adverse cardiac events.
On July 14, 2008, senior Amarin officials met with the FDA to determine whether
the design of its ANCHOR Study was “adequate to provide the clinical efficacy data
necessary to support the proposed [ANCHOR] indication[.]” SAC ¶ 114. The FDA
responded, as documented in the official minutes of that meeting (the “2008 Minutes”)
that it was “not aware” of any long-term outcomes trials demonstrating that the reduction
of TGs in patients on statin therapy significantly reduces the risk of major adverse cardiac
events. SAC ¶115. It then noted that three then-ongoing outcome studies, titled AIMHIGH, ACCORD, and IMPROVE-IT, “while not designed to address this specific gap in
knowledge, [would] provide important information on the incremental benefit of adding a
second lipid-active drug to statin therapy.” JA.483; SAC ¶¶ 4; 116. Consequently, the
FDA stated that “before [it] would entertain granting [Vascepa] an indication . . . ,”
Amarin would “at a minimum” have to submit data from the ANCHOR Study and
“initiate an appropriately-designed cardiovascular outcomes study” that was “well under
way” by the time the FDA began its review. JA.484; SAC ¶21. The Defendants did not
share the 2008 Minutes with investors.
Amarin later entered a Special Protocol Assessment (“SPA”) Agreement with the
FDA memorializing some of this feedback in July 2009 (the “2009 SPA”). An SPA
Agreement binds the FDA as to design, methodological, and approval criteria for a given
drug application, although the FDA may rescind an SPA if it identifies “a substantial
scientific issue essential to determining the safety or effectiveness of [a] drug . . . after
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the testing has begun.” 21 U.S.C § 355(b)(5)(C)(ii). In the 2009 SPA, the FDA agreed
with the proposed “design” of the ANCHOR Study, including Amarin’s proposed
“endpoints.” JA.508. But when asked whether statistically significant results from the
ANCHOR Study would “provide an adequate basis for approval” of the indication, the
FDA responded only that “[t]his is a review issue.” SAC ¶ 127. The Defendants did not
share all of the FDA’s comments in connection with the 2009 SPA with investors.
In April 2011, Amarin announced that the results of the ANCHOR Study showed
statistically significant reduction of TGs in the ANCHOR population. However, around
this time, two of the three outcomes studies mentioned by the FDA in 2008 (ACCORD
and AIM-HIGH) failed to achieve their endpoints.2 On a conference call between Amarin
and the FDA on April 14, 2011, the FDA told Amarin that an advisory committee “was
likely before the indication could possibly be granted.”3 SAC ¶ 247.
Four months later, the FDA and Amarin entered into a second SPA agreement (the
“2011 SPA”) covering the design and endpoints of the long-term outcomes study
mentioned as a “minimum” requirement in 2008 (the “REDUCE-IT Study”). The FDA
agreed with Amarin’s design of the REDUCE-IT Study, but again declined to commit to
approval criteria. See SAC ¶ 278 (noting that “approvability of the indication will be a
review issue”).
2

IMPROVE-IT, although not completed until after the Class Period, demonstrated
“modest favorable results.” In re Amarin Corp. PLC Sec. Litig., No. CV-13-6663 (FLW)
(TJB), 2016 WL 1644623, at *2 n.6 (D.N.J. Apr. 26, 2016); SAC ¶¶165–66.
3

In reviewing a drug application the FDA may—or may not—convene an
advisory committee (“AdCom”) of experts for guidance. The FDA is not bound by this
guidance.
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By February 2013, the REDUCE-IT Study was substantially underway, so Amarin
submitted a supplemental New Drug Application for ANCHOR. On October 16, 2013,
however, the FDA convened an advisory committee and voted to reject the ANCHOR
application because it found that there was insufficient data to support the use of reducing
TGs as a surrogate endpoint. The FDA, shortly thereafter, rescinded the 2009 SPA citing
the results from ACCORD, AIM-HIGH, and a third study not mentioned in the 2008
Minutes, HPS2-THRIVE, as establishing a substantial scientific issue.
The Defendants appealed the FDA’s decision to rescind the 2009 SPA, but the
appeal was denied. Reviewers, such as Drs. Rosebraugh and Jenkins, rejected Amarin’s
arguments and made clear that the 2008 Minutes “indicate[d] the fragile nature of the
evidence supporting TG’s hold onto surrogate status,” SAC ¶134, and “that there were
still concerns regarding [TG lowering],” SAC ¶137. Dr. Ketchum, one of the individual
defendants, acknowledged understanding as much from these minutes in post-Class
Period correspondence. The appeal decisions emphasized, however, that at the time of the
2008 Minutes and 2009 SPA, the FDA believed the scientific data supported TG
lowering and thus that the FDA was justified in entering the 2009 SPA. The decision to
rescind, Dr. Jenkins added, “was based on the accumulation and totality of scientific data
and information, including reevaluation and improved understanding of the relevant
scientific knowledge, that have become available since the ANCHOR trial began . . . .”
JA.685.

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B. Alleged Material Misrepresentations
Lead Plaintiff James Reiss then brought this securities fraud action, claiming
violations of §§ 10(b) and 20(a) of the Securities Exchange Act of 1934. He alleges that
the Defendants intentionally misled investors as to the material risk that the FDA would
require Amarin to complete an outcomes study at great cost and delay before granting the
ANCHOR Indication, by omitting to disclose the FDA’s “reservations” as stated in the
2008 Minutes and 2009 SPA. SAC ¶ 204. The Plaintiff then identifies eighty-seven
statements drawn from press releases, offering announcements, prospectuses, and
earnings call transcripts during the Class Period (the “Statements”) that he alleges were
false and misleading in light of these omissions.
The Plaintiff organizes the Statements into eight categories, but focuses on the
first in this appeal. In that category, he identifies fourteen statements wherein the
Defendants represented that a long-term outcome trial (REDUCE-IT) was “not required”
to be completed or that the Defendants “[did] not believe” one “[would] be required” to
be completed before the FDA approved the ANCHOR Indication.4 SAC ¶¶ 235; 353.
The Plaintiff alleges that these statements are false and misleading because the FDA had
indicated approval would be a “review issue,” and that an outcomes trial, “given the
4

The other seven categories included: (1) statements purportedly representing that
TGs were an accepted surrogate endpoint; (2) a statement characterizing the SPA
agreement as “strong endorsement” of Amarin’s strategy; (3) statements allegedly
mispresenting the import of the AIM-HIGH and ACCORD studies; (4) statements
misrepresenting the import of a Japanese TG study; (5) statements concerning the
placebo in the ANCHOR Study; (6) statements purportedly mischaracterizing the level of
enrollment required in the REDUCE-IT study; and (7) statements allegedly
misrepresenting market demand of the drug.
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failure of the ACCORD and AIM-HIGH trials, [was] almost certainly going to be
required by the FDA prior to approval of ANCHOR.” SAC ¶209(i) (emphasis added).
The Plaintiff also alleges that various statements to the effect that Amarin was optimistic
that the FDA would approve ANCHOR based on the ANCHOR Study amplified the
misleading nature of the Statements.
C. The District Court Opinion
The District Court, in two comprehensive and thoughtful opinions, separately
analyzed each category of statement and held that the Plaintiff failed to allege any false
or misleading statements. See In re Amarin Corp. PLC Sec. Litig., No. CV-13-6663
(FLW) (TJB), 2016 WL 1644623, at *1 (D.N.J. Apr. 26, 2016); In re Amarin Corp. PLC,
No. 13-CV-6663 (FLW) (TJB), 2015 WL 3954190, at *1 (D.N.J. June 29, 2015).
It reasoned, inter alia, that had the FDA wished to condition approval of
ANCHOR on completion of an outcomes trial, it would have explicitly said so. When
viewed in context, the “use of the language ‘review issue’ impl[ied] that it [was] possible,
although not guaranteed, that [the ANCHOR Study] would be an adequate basis for
approval.” In re Amarin, 2016 WL 1644623, at *10. Therefore, the Defendants’
statements that completion of an outcomes trial was not required before approval were
not misleading because “[t]hese statements merely accurately reflected the agreed terms
of the 2008 Meeting and the 2009 SPA.” Id. Similarly, any statements allegedly implying
that TG lowering was an accepted surrogate endpoint were not misleading because
“[u]nder the facts alleged, it is clear that at the time the 2009 SPA and the 2011 SPA
were executed, the reduction of TGs was still an accepted surrogate for the reduction of
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[major adverse cardiac events].” Id. at *17. For similar reasons, the District Court
concluded that none of the other Statements were misleading as to the FDA’s feedback in
2008 or 2009.
The Plaintiff appeals and argues that the District Court erred by “applying a
heightened pleading standard,” “weighing competing evidence,” and “not considering the
[S]tatements in the aggregate.” Reiss Br. 20. He maintains that a reasonable investor
would have been misled by the totality of the Defendants’ Statements into believing that
there was a “clear path to approval” for the ANCHOR Indication, when, in fact, there was
not.5
After independently reviewing the record, we perceive no reason to disturb the
District Court’s reasoning and rulings.
II. DISCUSSION6
Section 10(b) of the Securities Exchange Act of 1934 prohibits fraud in connection
with the purchase or sale of securities. See 15 U.S.C. § 78j(b). Rule 10b-5, in particular,

5

Oral Argument at 14:20–17:10, In re: Amarin Corp. PLC Sec. Litig, No. 16–
2640, available at http:// www2.ca3.uscourts.gov/oralargument/audio/162640InReAmarinCorpPLC.mp3.
6

The District Court had jurisdiction under 28 U.S.C. §1331. We have jurisdiction
under 28 U.S.C § 1291. We exercise plenary review over the District Court’s Order to
grant a Rule 12(b)(6) motion to dismiss. See In re Aetna, Inc. Sec. Litig., 617 F.3d 272,
277 (3d Cir. 2010). In so doing, we apply the Private Security Litigation Reform Act’s
heightened pleading standards, which require a private securities fraud complaint to
“specify each statement alleged to have been misleading, [and] the reason or reasons why
the statement is misleading.” 15 U.S.C. § 78u–4(b)(1).
At this stage we may rely on, in addition to the complaint itself, documents
incorporated by reference and undisputed in authenticity, including publically-filed SEC
disclosures. See Winer Family Tr. v. Queen, 503 F.3d 319, 327 (3d Cir. 2007).
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makes it unlawful to “make any untrue statement of a material fact or to omit to state a
material fact necessary in order to make the statements made, in the light of the
circumstances under which they were made, not misleading.” City of Edinburgh Council
v. Pfizer, Inc., 754 F.3d 159, 167 (3d Cir. 2014) (quoting 17 C.F.R. § 240.10b–5(b)). To
state a claim for securities fraud, a plaintiff must show (1) a material misrepresentation or
omission, (2) scienter, (3) a nexus between the misrepresentation or omission and the
purchase or sale of a security, (4) reliance, (5) economic loss, and (6) loss causation. See
In re Aetna, Inc. Sec. Litig., 617 F.3d 272, 277 (3d Cir. 2010).
The District Court dismissed the SAC under the first element, concluding that the
Defendants’ Statements contained no material misrepresentations or omissions because
they were not materially misleading. A statement or omission is materially misleading if
“there is ‘a substantial likelihood that the disclosure of the omitted fact would have been
viewed by the reasonable investor as having significantly altered the “total mix” of
information available’” to that investor. Matrixx Initiatives, Inc. v. Siracusano, 563 U.S.
27, 38 (2011) (quoting Basic Inc. v. Levinson, 485 U.S. 224, 231–32 (1988)).
We keep in mind, however, that Rule 10b-5 “do[es] not create an affirmative duty
to disclose any and all material information.” Id. at 44; accord Oran v. Stafford, 226 F.3d
275, 285 (3d Cir. 2000) (“Silence, absent a duty to disclose, is not misleading under Rule
10b–5.” (quoting Basic Inc., 485 U.S. at 239 n.17)). Rather, disclosure of material
information is required “only when necessary ‘to make . . . statements made, in the light
of the circumstances under which they were made, not misleading.’” Matrixx Initiatives,

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563 U.S. at 44 (alteration in original) (quoting 17 C.F.R. § 240.10b–5(b)).7 As the
Supreme Court has recently emphasized, “[e]ven with respect to information that a
reasonable investor might consider material, companies can control what they have to
disclose under these provisions by controlling what they say to the market.” Id. at 45.
Here, we agree with the District Court that none of the Statements, in context,
were misleading as to the FDA’s feedback; consequently, we hold that the Defendants
were not obligated to disclose the 2008 Minutes or 2009 SPA.
The lynchpin of the Plaintiff’s omission theory of liability is his allegation that as
the AIM-HIGH and ACCORD studies failed, it became increasingly likely, if not certain,
that the FDA would reject TG lowering as a validated surrogate endpoint. Given this, he
contends, the FDA was “certain” to require an outcomes trial to be completed prior to
approval, rendering the Defendants’ representations misleading.
But, in so arguing, we think the Plaintiff mischaracterizes the FDA’s position on
TG lowering during the Class Period. Viewed in their entirety, the SAC and documents
incorporated by reference reveal that TG lowering, despite the open nature of the
scientific question, remained a viable surrogate endpoint until 2013. In view of this, the
Statements, even taken together with the Defendants’ optimism, are not actionable.

We therefore reject the Plaintiff’s argument that the District Court applied an
improper burden or weighed competing evidence. Rather, the District Court properly
considered whether, in context, any of the Statements were false or misleading and
appropriately relied on documents incorporated by reference into the SAC. Its analytical
approach was sound.
7

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We begin with the 2008 Minutes. At oral argument, the Plaintiff’s counsel urged
us to read the FDA’s statement that it was “not aware” of any long-term studies to reflect
its position that there was “no association” between TG lowering and reduction of
cardiovascular risk.8 But the FDA never stated that there was “no association.” The FDA
never stated that TG Lowering was not a valid surrogate endpoint either. To the contrary,
the FDA expressly provided “minimum” requirements for consideration of Amarin’s
application based on this theory of proving efficacy. JA.484. Moreover, in the FDA’s
decision letter rejecting Amarin’s appeal (from which the Plaintiff quotes extensively in
support of his characterizations), Dr. Jenkins confirmed that “at the time of the [2008
Meeting], (as well as at the time of the ANCHOR SPA agreement) [the FDA] was still
willing to accept TG lowering as a validated surrogate for reducing CV risk . . . .”
JA.682. Thus, the 2008 Minutes actually show that TG lowering was an accepted
surrogate endpoint in 2008.
Nonetheless, the Plaintiff urges us to focus on the failure of the ACCORD and
AIM-HIGH studies. He insists the Defendants’ application was doomed as a result of
their failure because the FDA commented in 2008 that these studies would provide
“important information.” SAC ¶ 116. But the full text of that quote reads that ACCORD
and AIM-HIGH, while important, were “not designed to address this specific gap in
knowledge.” JA.483. The FDA, thus, did not opine that AIM-HIGH and ACCORD
would decide the issue conclusively. The post-Class Period documents show that in

8

Oral Argument at 4:21.
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reaching its decision to rescind, the FDA was swayed not only by ACCORD and AIMHIGH, but also by a third study not mentioned in the 2008 Minutes, HP2S-THRIVE. See
JA.947 (noting in a December 16, 2013 meeting that three studies, ACCORD, AIMHIGH, and HP2S-THRIVE, “reduced the [FDA’s] level of confidence”). We cannot say
then, as the Plaintiff insists, that the FDA viewed the outcome of the AIM-HIGH or
ACCORD as definitively deciding the TG question in 2008 or in 2011 after those studies
failed.
The Plaintiff next points to the 2009 SPA, particularly that approval was a “review
issue.” SAC ¶ 127. But we do not see how this advances his argument. In the 2009 SPA,
the FDA actually “agreed” with the design of the ANCHOR Study, meaning that it
agreed with its selected surrogate endpoint. JA.508. As the District Court aptly noted, the
FDA’s use of the phrase “review issue” meant only that “it [was] possible, although not
guaranteed” that a twelve-week efficacy would suffice. In re Amarin, 2016 WL 1644623,
at *10. The FDA’s entering into the 2011 SPA for REDUCE-IT after the ACCORD and
AIM-HIGH studies failed further confirms that the FDA had yet to decide the issue, but
was still willing to consider the application on this theory.
We think it clear from the 2008 Minutes, 2009 SPA, and 2011 SPA that the FDA
never explicitly or even implicitly indicated that a long-term outcome trial would be
required to be completed for approval. The FDA only wished to see that a long-term
study was “well under way,” JA.484, or “approximately 50% percent enroll[ed],” JA.406.
While quantification of that requirement, in terms of enrollment figures, appears to have

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been a matter of negotiation throughout the Class Period, there is no dispute, based on
these documents, that completion of such a trial was not required for approval.
Finally, we note that documents incorporated by reference make it abundantly
clear that the FDA did not conclusively reformulate its thinking on the state of the
scientific literature supporting the TG lowering hypothesis until after it considered the
“new” scientific evidence in 2013. JA.686; see also JA.685 (noting that the FDA’s
decision to rescind “was based on the accumulation and totality of scientific data and
information, including revaluation and improved understanding of the relevant scientific
knowledge, that have become available since the ANCHOR trial began” (emphasis
added)); JA.686 (noting that the FDA “could not know the outcome of the ongoing
[outcome studies]” and characterizing the “cumulative results” of those studies as “new
scientific information” (underline in original)); JA.687–88 (concluding that “weight of
evidence no longer supports” the use of TG lowering as a surrogate endpoint because of
the “important new scientific evidence” (emphasis added)).
In sum, far from being “extremely likely (if not certain)” to reject TG lowering as
a validated surrogate endpoint and require a completed outcomes study before granting
the ANCHOR Indication, Reiss Br. 22, the FDA remained open to Amarin’s strategy of
demonstrating efficacy; no well-pled allegation supports the claim that the FDA
reformulated its thinking prior to the advisory committee meeting.9 We therefore decline
9

At oral argument, the Plaintiff emphasized his allegation regarding the April
2011 teleconference wherein the FDA stated that an AdCom was likely. But we fail to
see how this indicated that the FDA was correspondingly “likely” to require an outcomes
study. It meant at most that the FDA would seek guidance on the TG issue.
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to accept as true the allegation that the FDA was “certain” to require an outcomes study
at the time of the Defendants’ Statements, even in light of ACCORD’s and AIM-HIGH’s
failure to produce supportive results.
Accordingly, we agree with the District Court that none of the Statements were
false or misleading given the FDA’s position on TG lowering. The Defendants never
expressly stated or implied that the 2009 SPA guaranteed approval,10 or that the FDA had
conclusively accepted TG lowering as a validated surrogate during the Class Period.11 As
the District Court correctly noted, the Defendants are merely alleged to have stated,
accurately, the minimum requirements for consideration as laid out in the 2008 Minutes.
We also find the Plaintiff’s argument that a reasonable investor would have
interpreted the Defendants’ Statements as presenting a “clear path to approval” to be
unpersuasive given Amarin’s contemporaneous disclosures. The Defendants’ publicallyfiled Form 10-Ks repeatedly warned investors that the FDA may rescind an SPA if it
identifies a “substantial scientific issue.” See JA.496, 521, 529, 536. The Defendants’
2011 Form 10-K, in particular, acknowledges that: “no outcomes study has been
conducted evaluating [Vascepa for the ANCHOR Indication];” “Outcomes studies of
10

The Defendants warned investors that SPAs, in fact, did not guarantee approval.
See JA.536 (“Our SPAs with the FDA are not guarantees of FDA approval of Vascepa
for the proposed ANCHOR and REDUCE-IT indications.”).
On this point, we disagree with Plaintiff’s characterization of his second
category of statements. He claims the Defendants represented, in his words, that “TG
lowering was an accepted surrogate endpoint for a long-term CVD outcomes benefit.”
Reiss Br. 35. The text of the statements actually says that TGs were a “risk factor” for
cardiovascular disease. SAC ¶ 194. The statements say nothing about the FDA’s position
on surrogacy and are therefore not actionable because the Plaintiff does not allege that
TGs were not considered a risk factor at the time of the statements.
11

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certain other lipid modifying therapies have failed to achieve the endpoints of such
studies;” “[t]here can be no assurance as to the final indication approved by the FDA,”
JA.196–97; and “the agency could assert that additional studies or data are required to
support a regulatory submission,” JA.529.
As other courts have recognized, a reasonable investor understands that a
“[c]ontinuous dialogue between the FDA and the proponent of a new drug is the essence
of the product license application process.” Tongue v. Sanofi, 816 F.3d 199, 211 (2d Cir.
2016) (alteration in original) (internal quotation marks omitted) (quoting In re Sanofi Sec.
Litig., 87 F. Supp. 3d 510, 542 (S.D.N.Y. 2015)). Here, a reasonable investor would not
have been misled by the Defendants’ Statements unless the FDA had foreclosed (or
provided conditions that obtained during the class period under which it would foreclose)
reliance on TG lowering as a surrogate endpoint. Because neither the 2008 Minutes nor
the 2009 SPA, fairly characterized, bear out the Plaintiff’s characterizations of the FDA’s
position, we agree that the Defendants did not have a duty to disclose them under the
securities laws.
The Plaintiff also emphasizes to us the Defendants’ optimistic projections of
approval. But just because the Defendants were aware of the TG issue and optimistic that
it would be decided in their favor does not necessarily mean their omissions are
actionable. See OFI Asset Mgmt. v. Cooper Tire & Rubber, 834 F.3d 481, 496–97 (3d
Cir. 2016) (holding that statement to that there was “no pending or . . . threatened . . .
labor strike” was not misleading when all the plaintiff pled with particularity was a risk
of a labor dispute and that the defendant “was aware of and was preparing for that risk”
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(first alteration in original)); City of Edinburgh Council, 754 F.3d at 170 (noting that
opinions are not actionable unless they are (1) not honestly believed and (2) lack a
reasonable basis); accord In re Merck & Co., Inc. Sec., Derivative & “ERISA” Litig., 543
F.3d 150, 166 (3d Cir. 2008).12 The Plaintiff fails to allege that the Defendants did not
honestly believe their projections (or their assessments of the scientific literature
underlying those projections); nor are there allegations that the Defendants lacked a
reasonable basis for so believing. To the contrary, the 2008 Minutes, taken in context,
show that they did have a reasonable basis for believing the FDA would approve the
ANCHOR Indication. The Plaintiff’s reliance on the fact the FDA ultimately rejected TG
lowering after a review of “new” scientific data would amount to pleading “fraud by
hindsight, something our Court has long rejected.” OFI, 834 F.3d at 497 (internal
quotation marks omitted).
Finally, we disagree that Zak v. Chelsea Therapeutics Int’l, Ltd., 780 F.3d 597 (4th
Cir. 2015), “compel[s]” reversal. Reiss Br. 26. In Zak, the FDA explicitly told the
Defendants in an SPA that it “expected two successful efficacy studies before it would
grant regulatory approval of the new drug” and later “warned . . . that a single successful
study typically was not sufficient to support approval of a new drug.” Zak, 708 F.3d at
602. Here, the FDA never required an outcomes study be completed prior to submission,

12

Although the Plaintiff cites Omnicare, Inc. v. Laborers District Council
Construction Industry Pension Fund, 135 S. Ct. 1318, 1329 (2015), a §11 case, as
supporting its argument, we decline to decide whether Omnicare is applicable to §10(b)
claims because even under the principles set forth in the Supreme Court’s opinion in that
case, our decision here would remain unchanged.
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or even, like in Zak, indicated that one would typically be required in this situation.
Rather, the FDA declined to adopt criteria for approval one way or the other, and waited
to see how the scientific literature developed. See SAC ¶126 (noting ultimate approval is
“a review issue”). Zak, therefore, does not help the Plaintiff.
We have considered the remainder of the Plaintiff’s arguments as to why the
Statements were false and misleading, but find them unavailing.
III. Conclusion
For the foregoing reasons, we will affirm the Order of the District Court.

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