Replies to post #208875 on Amarin Corp Plc (AMRN)

[ggwpq]

FDA is the judge and jury of the whole sNDA review process. FDA could deem any new info it requested from Amarin during the review process as an amendment. As a result, we won't be able to win the lawsuit, if any, regarding the 3-month PDUFA delay.

[MateoPaisa]

JL, your response is exactly why I have been so bewildered at all the rapidly changing speculation about what is going on.

I agree that had there been a label change, shareholders should have been notified; however, I may be wrong. We don't know what was on the first label request so we would not likely have been told what might have been in a second label request for likely the same reasons we don't know what's in the first. Based on that logic, it is reasonable to think that there would have been no duty to disclose a new label request to shareholders. If there had been a duty to disclose it, you can pretty much rest assured that the BOD and their advisors would have discussed disclosure and would have done the right thing. Failure to disclose can have massive negative implications (as you well know) and I just don't buy that management would not have known it needed to be disclosed; hence... there was no second label request

Nevertheless, JT stated in the 8/8 call that the PDUFA date would be December. Why? Because the AdCom is more likely than not about the first and only label requested by Amarin and, as a result of the AdCom, the PDUFA date would HAVE to be moved because they're certainly not going to grant a label change and THEN do an AdCom.

Everyone is making stuff up like mad.

Based on what we actually know (not what everyone is making up), it is far more reasonable to expect the PDUFA date will be delayed to some point after the AdCom.