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Came out of hibernation because I'm sick of reading your abject idiocy when it comes to politics. You can't connect two dots together like we did when we were kids, never mind trade a stock. You'll still be in denial once the indictments start flowing.
Thanks everyone for the great suggestions. Funny - Pretty smart to check out the supporting affidavits in the 1st A case. I should have thought of that. I actually went to the Court hearing in the SDNY and reported back here at the time. Thanx again.
Hi G. I sent you a private message. Would love to find a NYC doctor with some common sense who can prescribe V off label. Thanks much.
Do you have any idea why Amarin limited the China trial to the Marine population instead of Anchor? Is there a requirement in China that the indication must be FDA approved before trials can commence for the same indication in China? Otherwise, I would have expected Amarin to pursue the larger indication.
On a related note, is trig reduction accepted as an appropriate bio-marker in China? If so, all the more reason I would have expected Amarin to pursue full Anchor in China.
Any thoughts by anyone?
I agree.
AMRN would not be waiting for the FDA to do anything. It would be a give and take collaborative process. Because I have lived these scenarios before, and having negotiated with public entities, I am fairly confident that I can "understand" the process. Do you really have to be a dick to people with interpretations that might differ from yours? Too much Florida sun my friend.
You could very well be right. The choices seem to be (1) ANCHOR label related; (2) Reduce-It related; and (3) Determining form and substance of various statements of fact from studies, (Jelis, etc.) that AMRN wants to use in its promotions. It really shouldn't have taken AMRN and the FDA so long to do (1) and (2), which might lead one to focus on Reduce-It. But then the timing thing keeps occurring to me. And I disagree that the parties could not have told the judge that they wanted a stay of the action and a preliminary injunction to continue to March 2016 if they were waiting on Reduce-It. The Court would have been more than accommodating if the request had been jointly made. So its a puzzlement to me.
You think the notion of a bumbling federal bureaucracy taking six months to decide on the precise phraseology and presentation of various studies and peer reviewed articles is "retarded" but think it has taken the FDA an equal amount of time to make a thumbs up or thumbs down decision on granting the ANCHOR label expansion? Seems like that would have taken LESS time. Look, I hope you are right -- it's certainly a logical and fair resolution. But until I see it, your argument sounds kind of . . . . . . .
Raf - I don't know but I would not be surprised if the delays related solely to wording/communications with doctors relating to ANCHOR as well as other peer reviewed published test results.
The thought that the delay is related to Reduce-It is intriguing, but the prior deadlines agreed to by the parties do not jibe with that conjecture. It is not unusual for negotiations such as these to drag on, particularly when there is an injunction in place and status quo maintained.
But I would be delighted to hear that AMRN negotiated expedited review, etc. as speculated here. The one thing I have learned from this debacle is never to expect too much.
Wow. Not a single case against the FDA or its predecessors going back to 1870. That should tell you something.
You have cited numerous cases against Governmental agencies principally involving takings of property. My argument was not that there isn't well-developed jurisprudence regarding takings of property by governmental agencies -- obviously that is why the doctrine was developed. But none of the cited cases involve collecting damages from the FDA based on an administrative decision relating to labeling, which was somehow construed as a "taking". No such case exists, my friend.
Can you imagine if every pharmaceutical company that felt wronged by an FDA decision involving their drug could file a claim for lost profits based on a claimed 'taking" by the FDA??
I assure you that if there was any chance AMRN could collect damages against the FDA, its crack team of world class lawyers would have asserted it in the Complaint.
Your time would be better spent praying on your hands and knees for a favorable Reduce-It outcome, (as I am) and I'm not a religious man. LET'S HOPE FOR AN EXCELLENT NEW YEAR AND AN INTERIM STOP!!!!!!!!!
I am trying to explain to you the legal realities of this case, based on my experience as well as being probably the only poster here who was actually in the courtroom for oral arguments. As usual, you simply don't want to listen. I assure you I have more on the line here than you, and would be the last person to want to spread FUD. You do not help the cause by setting up unrealistic expectations.
The fact that the FDA did not appeal does not make the preliminary injunction any less "preliminary". It is a temporary measure that stays in effect only until the end of the case, not 'forever" as you imply. If AMRN wins "the underlying litigation", then the temporary injunction will be made permanent.
Guess what. There are cases where a preliminary injunction is granted to one party and later at trial the Judge dissolves the injunction and decides against the party in whose favor the injunction was originally granted. A preliminary injunction is entered based on a strong likelihood of success, not final success on the merits. Here, by not appealing, the FDA merely acknowledged that a preliminary injunction would stay in place pending trial or settlement of the case.
I'll repeat my main point: There will be no money damages and no discussion of money damages and no discussion of the Fifth Amendment, IMO. I can only speculate on the reason for the delay, so I won't bother. My sincerest hope is that AMRN is negotiating for something in addition to what they demanded in the complaint (the right to communicate ANCHOR and other test results to doctors),but I am highly doubtful.
Time will provide the answer.
Incorrect. What IR has confirmed (consistent with my previous post) is that the settlement discussions involve the causes of action alleged in the complaint, INCLUDING what Amarin can already say about Vascepa, which has only been PRELIMINARY approved by the Court as part of the preliminary injunction.
AMRN is NOT discussing damages and has not alleged any cause of action for damages. Why would the FDA even consider discussing damages (assuming such damages are recoverable, which I am doubtful of absent ANY legal support) when it hasn't even been sued for damages?
Everyone is expecting AMRN to walk away with more than it sued for because it has already "won" everything else in the PI. That is just not correct. The settlement will benefit AMRN because it will address what AMRN can say on its label nationwide (not just in the SDNY where AMRN sued), and precisely what it can say on the label in more detail than addressed in the opinion. It will also make permanent (without a trial) what the Court has decided in the preliminary injunction.
Why should the foregoing take so much time? That is a mystery I do not have an answer for. Maybe something else is brewing. Who knows? But rest assured, there will be no damages, and likely nothing more than is requested in the Complaint.
Agreed. Which is precisely why our Biobill is tilting at windmills. Better to invest energy in social media to educate people regarding Vascepa than to continue to threaten actions against the FDA or AMRN management.
Rephrasing and then expressing your personal disagreement with the examples I came up with off the top of my head to explain why the company might legitimately decide not to fund three lawsuits doesn't advance your argument. The point is, agree with the reasons or not, basing a business judgment on them would not be "gross negligence." If reasonable minds could differ, its not gross negligence. It may be a bad judgment, or a wrong decision, but that's not enough. In short, in the real world, the business judgment exception is big enough to drive a Navy destroyer through. The reason used could be as simple as "we don't believe we have enough $ to fund the lawsuit" to pass muster under the Business Judgment Rule.
To quote the language you posted: "As long as there was no gross negligence or self-dealing in the decision-making process, directors generally will not be held liable for bad decisions or mistakes that result in harm to the corporation.This rule was intended to protect directors from errors in judgments and mistakes."
You would think that the lack of a SINGLE reported lawsuit in the history of American jurisprudence in which damages were awarded to a pharma company (or even claimed by one) against the FDA based on a violation of the Takings Clause would give you some pause.
Re-read the language you quoted regarding the business judgment rule. It is a huge defense to claims of breach of fiduciary duty. You would essentially have to show that the director acted with gross negligence, which is an extremely high standard. Also, as the language you quoted explains, the director is permitted to act on the advise of outside consultants, i.e., AMRN's lawyers.
The lawyers may have advised any of the following: focus on 1st Amendment and NCE which we can win in an extremely short time frame and with minimal cost; the company is not likely to get any monetary recovery from the FDA; damages may be too speculative as the stock may recover and therefore shareholders who held will have suffered no calculable damages; the cost of the suit would be excessive and the case would not resolve itself until long after Reduce-It results; no guarantee that the company would win given huge amount of discretion afforded FDA among other factors; too many lawsuits at one time would be viewed negatively by Wall Street as too much overhang and irreparable relationship with FDA, etc., etc.
Agree with any of the foregoing or not, any one of those reasons would have been sufficient for a director to conclude that another lawsuit at this time was ill-advised, and based on the business judgment rule, there would be no liability.
This is coming from a person who thought the company should have sued on the SPA withdrawal at the time, so I'm sympathetic. But I'm also practical.
Can we please put this notion of antitrust violations to bed already? If the company was suing for an antitrust violation or a "taking", there would be separate causes of action clearly alleged in the Complaint, and there would be a specific prayer for compensatory damages related to each. There would be no reason to read between the lines of the Complaint and engage in creative wishful thinking.
The use of the term "costs of the action" is boilerplate language found in all complaints and refers to costs such as filing fees, deposition costs, possibly costs for subpoenas, copying, etc. It does not refer to compensatory damages such as lost profits.
The "underlying action" is a term of art used to refer to the substantive causes of action alleged in the Complaint, as opposed to the preliminary relief afforded by the injunction. It is a term that recognizes that the preliminary injunction is not a final disposition of the entire action but is merely a temporary disposition granted while the "underlying action" that is the subject of the PI is further litigated. It does not imply that there are other causes of action to be pursued other than what is laid out in black and white in the Complaint.
The fact that there were antitrust lawyers sitting at AMRN's counsel table also tells us nothing. Antitrust lawyers typically also handle straight up commercial litigation. There isn't that much antitrust work out there to be honest.
So, AMRN is NOT seeking, and appears to have no intention of seeking, compensatory damages (lost profits, etc.) and is not asserting causes of action for violations of due process or antitrust.
Please note that I continue to be a Stumbling Bear. Given the size and timing of my investment, there is no running away from this stock. I'm in it for the long haul.
FYI, I became a Stumbling Bear after the FDA hit me with a 2 x 4 at the Ad Com.
WINNING! 71-page opinion by Judge Engelmayer: For the foregoing reasons, the Court grants Amarin's application for preliminary relief. Specifically the Court declares that: (1) Amarin may engage in truthful and non-misleading speech promoting the off-label use of Vascepa, i.e., to treat patients with persistently high triglycerides, and under Caronia, such speech may not form the basis of a prosecution for misbranding; and (2) Based on the information presently known, the combination of statements and disclosures that Amarin proposes to make to doctors relating to the use of Vascepa to treat persons with persistently high triglycerides, as such communications have been modified herein, is truthful and non-misleading. The Clerk of Court is respectfully directed to terminate the motion pending at docket number 5. An order will follow shortly as to the next steps in this litigation. (As further set forth in this Opinion and Order.) (Signed by Judge Paul A. Engelmayer on 8/7/2015) (tro)
Decision just posted in Amarin v. FDA! Amarin gets injunctive relief! Haven't read the decision beyond the first paragraph, but that's the bottom line folks. WINNING!
Incorrect. The provision you quoted is stating that if someone like Amarin went into Court without notifying the adverse party (the FDA) of its request for an injunction, the court could grant the request, but would likely require Amarin to post a bond in the event the injunctive relief damaged the adverse party, and was later determined to be improperly granted.
This has no bearing on our case since Amarin provided notice and the issues were fully briefed. A party only goes into Court requesting an injunction without notifying the other party when there is some emergency preventing notice. Even with notice, the Court could always require a bond. But that is not our type of case.
I don't keep that kind of company.
Courtroom was totally full, but it was hard to tell whether a lot of attendees were other lawyers at Cahill, summer interns, etc. It certainly wasn't a media circus. There were a few media types for sure, but I didn't ask their affiliation.
To answer your other question, the Judge was never argumentative; totally even-tempered and accommodating. Even when he clearly did not agree with an FDA position, he did not make it obvious or make the FDA look bad. I was impressed.
Thanks. I think both parties recognize that the injunction basically decides the case. The Judge asked some questions about what the FDA intended to do if he decided against them, in terms of seeking a stay of his order pending appeal to the Second Circuit, but the FDA was non-committal.
No mention whatsoever of anti-trust, nor would I have expected it. No mention of FDA "poor treatment" of Amarin or bad science behind recession of SPA, etc. Stuck strictly to the Complaint.
There are lots of tidbits in my notes which I hope to post when I get a chance. For example, FDA started their entire argument disagreeing with Amarin's claim that the drug is "safe" and is not an issue. She argued that safety is still an issue because the drug can only be "safe" if there is an actual benefit that was established. Since no benefit demonstrated for that population, then safety remains an issue. The Judge looked somewhat perplexed at this line of argument, stating, "I thought that "effectiveness" is separate from safety. Is there a safety problem? Have you heard any complaints from the field from all the people taking Vascepa?" FDA: No. But the Anchor population is much bigger -- 36 million -- and there is no data on whether there would be safety issues in that population. Judge: But you have approved Marine -- if there was a safety issue, why would you have done that? FDA: Because it was safe in that context; a drug is not safe if it is not effective.
The Judge did not buy any of this and it was exactly the wrong way to start the FDA's argument.
Another nugget: Judge: So if doctor calls Amarin and says I have questions about what are FDA approved uses for Vascepa vs off-label uses, and if Amarin answers truthfully, its not misleading, but if Amarin calls up the doctor and has the exact same conversation, the speech is misleading because there is an intention to promote off label? FDA: Yes. Judge then points out that everyone knows that the intention is always to promote the drug.
Judge also asked why the FDA didn't appeal or re-try Caronia -- no good answer.
Judge delved into whether there were mechanisms to change course if he issued an injunction and new science came out disputing the claims. All basically agreed there were mechanisms in place including consulting with Amarin, asking the Court to overturn its order, or withdrawing the drug from the market.
Court also asked how long it would take to finalize their "guidance" as expressed in the letter to Amarin. The FDA attorneys looked at each other blankly. The Judge: Two months? By Labor Day? 2015? Can you give me something to give me an idea whether the FDA might issue something to narrow the focus of this? FDA: No response. Silence. "We really cannot say how long it might take. Public comment could take a year."
I don't want to imply that the Judge was ever critical of the FDA or torpedoed them or expressed obvious dismay with their arguments. The Judge was completely impartial. He just peppered them with hypotheticals that they simply couldn't answer and pointed out the inconsistency of their positions and the fact that they have not successfully distinguished this case from Caronia.
And now back to work!
Stumbled into Judge Engelmayer's Courtroom this morning to hear oral arguments. I concur with previous poster that, in my opinion, an injunction will issue. The only question was what the scope of the injunction would be. There was no indication about timing of the opinion, but it is likely to be soon given the nature of the relief requested and showing of irreparable harm.
Oral argument went from 9:00 to 11:45. About an hour each side plus rebuttal time for Amarin. Floyd Abrams argued for Amarin, (assisted ably by another attorney from Cahill) and the Judge was clearly pleased to hear argument from one of the lions of the First Amendment bar. Ellen London for the FDA was somewhat dreadful. She mumbled her way through the argument, making it impossible for the Court reporter to understand her on numerous occasions.
Judge clearly has a different view of Caronia than that of the FDA. Judge also had issue with the FDA's treatment of OTC Omega-3's vs Vascepa. Judge to FDA: 'This is an unusual case in that the most contested disclosure regarding 'supportive but not conclusive evidence supports the fact that EPA may reduce cardiovascular risk' is one that the FDA has otherwise embraced" The Judge did not buy the FDA's attempt to distinguish the "truthful and misleading" nature of each statement based on context. Judge also didn't buy why something stated in a report or scientific paper or print publication was truthful and misleading, but not when discussed or disseminated orally.
Judge said to the FDA,'you have been inviting Amarin to market the drug as OTC, where they could make the claim about "substantial but not conclusive" evidence of reduction in cardio-vascular events. Let's assume that Amarin did that for the Anchor population, but continued to market Vascepa as a prescribed drug for Marine. So you would have the exact same drug for two different indications. Why should the statement be considered truthful and not misleading in one context and not in the other? The FDA didn't have a good answer.
At the end of the day, the Judge wanted to hear specifics about how he could fashion relief. he was particularly focused on other proposed claims and tweaks set forth in the Ketchum Reply Affidavit at paragraphs 22, 25. When the Court spends that much time on those specifics, he is going to issue an injunction and is just considering the wording.
The Judge complemented the parties on their "superb" briefing of the issues, but you had to believe he was mostly congratulating Amarin's team. The Judge was smart as a tack, knew the record and knew his First Amendment law. At the end, Floyd Abrams had more time to argue, but basically said "nothing further." I think he knew there was no need for anything further.
Agree 100% with your Part B "Current Thinking." Could not have said it better. I'm going to do my best to attend oral argument on the 7th.
Glad to have you fully on board!
Now that BP has entered the fray, the FDA is really up against the wall. I think it also makes a settlement much more unlikely. As we can see from the Amicus briefs, the FDA cannot agree to special treatment of Amarin (as it half-heartedly attempted in its letter to Amarin) without extensive public scrutiny and being called out by other BP companies. And, I think there is also some pressure now on Amarin to go forward since Big Pharma desperately wants this case litigated -- Amarin is the perfect plaintiff due to the "peculiar" facts of its mistreatment at the hands of the FDA and the efficacy and safety profile of its drug.
I have got to hand it to Amarin's management and their legal strategy. Amarin carefully selected cases it knew it would likely win, quickly and at nominal cost. They also happen to be the cases that inflict the most organization-wide damage on the FDA. The SPA rescindment case would have taken forever, with experts debating what constitutes "substantial scientific evidence." And with the deference traditionally accorded the FDA's interpretation, the end result might have been a closer call.
To think that the FDA could have still adopted its new policy about acceptable biomarkers and the need for hard proof of efficacy and avoided all of this if it had simply honored the SPA and grandfathered in Amarin. That would have been the most logical thing to do, which always brings me back to ulterior motives and malice. Now, I'm afraid, to quote a phrase, it's "all or nothing."
Nice post. Agree on all fronts except I think Anchor on the label is unlikely. That would be an enormous victory to say the least.
Very nice post. Hey, HG, I'm a fellow Hungarian and even I can understand what jl is putting down
You keep referring to a "protracted legal battle." Was the NCE case a "protracted legal battle"? No -- it was decided relatively quickly on the papers and without a trial.
As previously stated, a preliminary injunction motion requires an immediate decision from the Court because of the "imminent" and "irreparable" harm to the company. In this case it will likely be decided based on the legal papers and oral argument -- not a trial. The decision will be rendered by the Judge at the oral argument or shortly thereafter in July. The company has already filed its opening brief. Do you suggest that the company now abandon the case to save on the legal cost of submitting a Reply Brief and attending oral argument?
If Amarin wins the injunction in July their sales people can immediately begin promoting Anchor and start educating what we all acknowledge to be sadly uninformed physicians. That's a big win, and no, I can't put a monetary value on it but my gut tells me it may result in significantly more scripts and perhaps more crucially, public awareness. Surely enough to pay for a Reply Brief and oral argument.
If Amarin wins the motion, the Judge will effectively be telling the FDA that absent some seismic shift in the facts or the law, they will ultimately loose the case and that Amarin is highly likely to obtain a permanent injunction. IMO, if the FDA looses the injunction they will capitulate and will not continue to fight a "protracted legal battle." Even if they chose to foolishly fight on, I think this case is very much like the NCE case -- it can be decided on the papers and without an extended trial.
So cost/benefit wise, this is a no- brainer.
You have set up a straw man with your assumption that Reduce-It will be stopped at interim. We investors would be the first to criticize the company if they did not have a Plan B in place to improve the chances of financial solvency (without dilution) in the event the study continues into 2017-18.
I think you are also exaggerating the "protracted" nature of this legal battle. The Judge is going to rule on Amarin's motion for a preliminary injunction in July. Inherent in that decision (if positive for Amarin) is a finding that Amarin is "likely to succeed" on the merits of the case. The practical effect of that decision (obtained at a relatively low cost) would be that Amarin could immediately disseminate truthful information about Anchor (even pending an appeal).
Incident to that would be the best publicity money can buy for Vascepa and heightened public/professional awareness. Moreover, such a finding would put Amarin in an excellent negotiating position, and the fear of God in the FDA.I am not saying that Anchor will be approved, but the FDA is likely to offer Amarin most if not all of what it seeks in its Complaint in order to avoid another precedent setting court decision on First Amendment grounds.
In short, economically and strategically, the company's decision to go forward with the case makes sense.
See my other post to BB. It's highly unusual, particularly in a case of this complexity, that a Judge will make a ruling "on the spot" from the bench. I think both motions were temporarily "held in abeyance" to permit the parties to supplement the record, which they did.
I'm speculating, but I would assume that once the parties submitted the information, the Judge began to write his opinion. So in my view, the next thing to expect is the actual decision/opinion by the Court.
The situation is a little different when both parties submit cross-motions for summary judgment. In that instance, both parties agree that there are no material facts in dispute and the Court can decide the case without a trial, on the papers. It is rare that a Judge will not grant summary judgment to one of the parties when both agree, as in this case, that summary judgment is the appropriate vehicle to resolve the case.
Looking at the NCE case, it is difficult to see that there are any facts in dispute. It will be up to the Court to determine whether Vascepa was entitled to NCE or not as a matter of regulatory/statutory law and applicable precedent. [The issue of why the FDA decided not to grant Vascepa NCE or delayed its determination, IMO, will be irrelevant to the Court's determination].
Not sure why the docket states that the hearing is "held in abeyance" other than the fact that the Court permitted the parties to submit post-argument information, which they did. Therefore, I suspect the Court is now deciding the motion and writing its opinion.
Highly doubtful that "held in abeyance" has anything to do with negotiating. The FDA has been steadfast in its position, and refused any suggestion of compromise even at the invitation of the Judge: "all or nothing" is their approach.
I think you have correctly identified the judgment that the Court will render, i.e., the relief the Court will hopefully grant to Amarin. However, this is a complex and highly contested matter, that will have ramifications beyond the Amarin v. FDA lawsuit. Judge Moss is obligated to set forth his findings of fact and conclusions of law in a written opinion, if for no other reason than to protect his opinion from reversal in the event of an appeal. I think we can expect a well reasoned, lengthy opinion.
I agree it is highly doubtful the Judge will make reference to the SPA fiasco. The issue was not raised or briefed by either of the parties.
However, I think the Investor lawsuit in the District of N.J. might provide some helpful information that Amarin might use to re-open negotiations with the FDA re Anchor, or to re-consider a lawsuit. As I understand it, the Judge in the Investor lawsuit will necessarily decide what the FDA told Amarin, and what the terms of the SPA were. Although the Judge's findings of fact, or any compelling reasoning, would not be binding on another Court in a subsequent lawsuit by Amarin against the FDA on the SPA, the decision could be used to persuade another Court that Amarin was wronged, or to potentially bring the FDA back to the table.
Yup. If you read my posts today and last night you'll know I completely agree with your analysis. I would still like to see the actual SPA document if there is one. (I thought it was going to be disclosed in the Investors lawsuit). Thanks for all the good info re inflammation.
Do any of our scientifically inclined posters or doctors have any comments regarding the subject raised by sts in his post, as it may be key to all our investments?
There is no one who would love to see that happen more than me. But having some understanding how Judges function, and apropos of an earlier thread on this board, the Court is not going to go delving into the comments to the CP and start speculating about FDA motivations, Big Pharma corruption, etc. (IMO). The Judge is not going to go beyond the arguments presented by the attorneys in oral argument and in their papers. There is a good reason that C & B did not directly raise extraneous matters -- they want a clean decision and know that by introducing other matters that have not been proven and can be disputed, a favorable result would be jeopardized.
The nature of a summary judgment motion is that there are no material facts in dispute and therefore no need for a trial. An attorney making a summary judgment motion purposely steers clear of any facts that can be denied or disputed.
All that being said, if the Court decides in Amarin's favor and delves into what you are suggesting, I'd no longer be a stumbling bear.
I have to disagree. First, what we are reading is a press release, not the contract itself. The press release, as a cautionary disclaimer indicates that the FDA MAY take the position that the SPA is not binding. It does not state that Amarin agrees it is not binding or that it is not binding as a legal matter. And it does not state that the FDA has unlimited discretion to determine whether a substantial scientific issue exists or what kind of trials to rely on.
The parties' intent at the time of contracting is what should govern. At the time of the SPA trig reduction was considered by the FDA (and Amarin) to be an acceptable biomarker. Vascepa is efficacious in reducing trigs in the Anchor population and reduce-it was substantially enrolled. It seems to me that the FDA changed the intent of the contract after the fact by turning "efficacy" into a consideration of whether trigs reduced MACE. But that was understood by all parties to be decided by Reduce-It which Amarin dutifully, and at some cost, substantially enrolled.
But we are all arguing in a vacuum since we don't have the actual SPA. A press release doesn't cut it.
Thanks for this. However, I'd really need to see the actual contract to have an opinion. Was there any previous SPA tied solely to Anchor? This is all about Reduce-It except:
"Once REDUCE-IT is substantially underway, the Company believes that it will have met all of the requirements to request approval of AMR101 for treating the mixed dyslipidemia patient population studied in the ANCHOR trial."
Also, there is some disclaimer language, which really does not state an agreement by Amarin that the FDA could pull the SPA if it unilaterally determined that other test results raised questions about the efficacy of the drug or its ability to reduce MACE. It just states that the FDA might take that position:
"An SPA is generally binding upon the FDA unless a substantial scientific issue essential to determining safety or efficacy is identified after the testing begins. However, there can be no assurance that this will be the case. If the FDA does not consider the SPA to be binding, the agency could assert that additional studies or data are required to support a regulatory submission."
I agree. That's why I wouldn't assume that delay is bad for Amarin as one poster previously suggested.