Replies to post #27773 on Amarin Corp Plc (AMRN)

[ggwpq]

If it's on Hamburg's desk, that means Amarin lied again during conference call.

[HDGabor]

I am not surprised. As I wrote in #27382: „If Hamburg does not want to deal with this issue, maybe we get positive answer from Woodcock by October. (if Woodcock has the same attitude, Dr. Jenkins level will be reinstate the SPA by end of July)”.

ggwpg - Amarin did not lied: officially it is OND level, but technically it will decided by Hamburg (/Woodcock).

louieblouie - the question is not "is it true or not?" but "is it logical or not?"

Maybe I am wrong on reinstatement, but based on your info I guess we will get the final answer from FDA on OND level (if it will be no we have to go through the next 2 level before the court but it will be technical steps only.)

Call me optimistic, but I think the background of the appeal is strong enough for a “green lamp” from Hamburg, resulted in a positive decision from OND level and after that the sNDA will be approved (for =200 mg/dL and <500 mg/dL population with compromised label.)

pros:
- the drug is safety and effective
- the study was 100% according to the SPA
- OND level is the originally targeted level (not a surprise, since the previous two played an active role in recession of SPA)
- (I guess) the next two level does not want to deal with this appeal officially (let’s say they do not want to overturn the previous levels’ decision and they do not want to go to court.)

cons:
- negative AdCom vote, however they voted on Reduce-It
- new science, however the background is not the strongest (especially as the population in the 3 citied study were different and the sub-group data did not confirm the “new” science)

(ps.: I never requested a proof from anybody, but I always analyse the logic of the statement)

[BioChica]

O.K. Let me say it: The next 60-90 days will be interesting!

[sts66]

How did the appeal manage to jump over two of Hamburg's underlings? FDA has followed all protocol so far for appeals, why would they speed it up now? Unless threatened legal action is forcing their hands or similar - but once Hamburg issues decision legal proceedings can start, AMRN can go to court - hard to believe that the FDA is anxious to allow this to happen, unless she's reversing lower decisions, also hard to believe.

BTW, not knocking you, so don't take offense to the following, most everyone here is quite happy about the work and time you've spent on our and AMRN's behalf - but you're saying "just trust me", same thing Ajax did, and he got a heap of dung dropped on his head. Will be interesting to see if you get the same reaction....

[alternatepatel]

rescission should be reversed on the very first and basic argument that the FDA guidance on SPA rescission was violated, the procedure wasn't followed. (New science!, concerns to public health! etc. etc.)

[alternatepatel]

Biobill, u mean Decision on CP or SPA ?