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I don't think anyone us realm thinking of filing a court case, but just saying FDA can't do anything it wants and needs to deal and deal fairly with Amarin.
Amarin has been telling people personally and I believe at the CC they knew nothing and haven't been yet informed. Amarin is very careful what it says normally. The FDA will disclose what it told Amarin if there is any dispute. Would Amarin really lie and subject itself to liability?
But then doesn't that have to be in writing and some have said here made public?
Not disagreeing with you but do you have an opinion on Amarin being able to do something about following the SPA?
I would also include in letter that no public health issues are involved and certainly none that were unrecognized at the time the SPA was agreed to by the FDA
If it qualified as substantial it would have a unanimous vote, not 9-2, and some just voting no because off label available.
I said the same thing that after the briefing document came out, Joe knew all about this and his lawyers would be prepared. But it was obvious at the CC that Joe did not want to be there and was blindsided. His lawyer indicated it might be illegal and answered a question incorrectly because not prepared.
Joe scheduled the CC for a victory party.
Yes substantial, but the point I'm trying to make is the part above that, that describes the not follow rule, says:
" . . . the Agency will not later alter its perspective on the issues of design, execution, or analyses unless public health concerns unrecognized at the time . . . "
This overrides the following which are just bullet point examples. The need to protect public health is the reason to breach a SPA, not patients might be wasting their money.
Not true at all. Congress grants authority and sets goals for agencies like the FDA, but the agencies make the rules and set the details. Congress might make the agency rules into laws but they don't sit around making all the detailed rules.
And the FDA can ignore the SPA if the science changes but that sentenced is prefaced with to insure public safety. Also the FDA nor any agency is not the last word, a court is.
That sounds good and a way to not involve SPA violation.
Section VII of the FDA PDUFA document describes the process for dispute resolution, which if that doesn't work a federal court can make a judgment. Congress can't do anything but use threats to take power from the FDA
I don't know what happened in the other stock, but in Amarin's case it seems the Adcomm was set up and manipulated by the FDA in order to be able to breach the SPA, the FDA will deny in December unless pressure is put upon it to reverse.
"Changing the vote question last minute" Did that really happen?
Or reduce trigs per guidelines
Can't tell if signs or just lawyer warning about everything he can think of
But obviously the FDA's actions and this subject is very controversial to the whole world and it might be pressured to make a deal with Amarin
FDA might have violated rules because FDA closed. Most employees at the FDA were furloughed, probably attorneys and other watchdogs were home and only skeleton crew present paid for by PDUFA fees.
I have no doubt that Reduce-It will succeed even if trigs don't matter
Not true, they need to notify Amarin in enough time to allow a meeting to work out differences. They have no reason to delay PDUFA.
SPAs are binding unless public health concerns arise. If you read section of FDA document introducing the part on not following a SPA:
"The agency will not alter its perspective . . . unless public health concerns unrecognized at the time of protocol assessment. . . The special protocol assessment should be considered binding"
Also that 30-day meeting needs to be requested by Amarin.
Required FDA-contact to breach SPA becomes new NCE. As time goes on every info of no FDA contact will be like OB coming out without NCE.
I agree those CPs seem to be pretty powerful.
I think the panel was just answering the loaded question, not approving or disapproving Vascepa. But Hiatt's statement can be used in any negotiations or legal action. The FDA wants the panel to protect the FDA, but stuff like that will hurt it.
You think they think they'll get it at a bankruptcy?
You really don't think a buyout is probable to replace Lovaza?
I sold from my individual account to meet deadline to put into SEP account, need loss for tax purposes, but in 30 days I'll buy back, good chance at least double money
Yeah but the approval isn't conditional on the results of the study, didn't we already have a requirement to do Reduce-it?
I'm not good at evaluation but $9 sounds good at this point.
But was the approval conditional upon the results of the study and this was at Adcomm?
Right and I understand from posts here that new guidelines recommend treating lower trigs even if FDA not sure, so the off label Lovaza and increasing Vascepa will continue nonetheless.
Sounds good but do they do conditional approvals?
But you're both right in that Amarin has to be formally notified, a meeting allowed, and possible modifications allowed. If the FDA is obviously wrong or did not follow rules a court will make its own judgment which overrides the FDA's.
That's not true at all. The courts first require you to exhaust all your other remedies before coming to court. Government agencies spend a lot of time in four for making disputed determinations. I don't see anything in the statute saying FDA is last word.
I couldn't listen, but one of the panelists thought off label was an alternative?
I'd help too. I think problem all the smart people here owned AMRN and reinforced each others' desire to do well and collectively didn't react to warning signs like 200k puts expiring in 24 hours. But we all know what a wonderful drug Vascepa is.
The FDA set up the Adcomm, including the questions to have cover to breach SPA, it won't go against unless forced.
You have to file public papers in a public court to initiate a lawsuit. Which courts are these in so we can all look them up and view the complaints?
There is no lawsuit against Amarin
But even at that the FDA doesn't want other drug companies to think renege and not want to enter into a SPA.
Not really, lawyers look up everything in Westlaw,it's so rare they would have never experienced it.