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Re: Mellowmood77 post# 207557

Saturday, 08/10/2019 1:00:10 AM

Saturday, August 10, 2019 1:00:10 AM

Post# of 424406

For god sakes they scheduled an ADCOM after the PDUFA date.

I think the reason for this is because we didn't get the complete story yet, hence FDA asking Amarin to hold off PR'ing it. One of two things will be PR'ed any day now:

1) PDUFA December 28

2) approval of narrow label & PDUFA December 28 for a broader label

Why did we get a partial update? I still think that as a result of the FOIA'ed documents, Amarin learned of upcoming AdCom, approached FDA and FDA confirmed the AdCom, but didn't provide any additional details because Amarin surprised them.

Nothing else makes sense. FDA wouldn't just unsolicitedly inform Amarin of the AdCom without providing further details and ask them not to PR it. Under normal circumstances, FDA would only notify Amarin when they have the complete story and are ok with Amarin PR'ing it.

Additionally, why would Thero throw FDA under the bus the way he did yesterday. He could have said nothing about FDA asking him not to PR it.
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