Saturday, August 10, 2019 1:00:10 AM
For god sakes they scheduled an ADCOM after the PDUFA date.
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.
Recent AMRN News
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- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/04/2026 12:00:07 AM
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- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/04/2026 12:00:05 AM
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- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/06/2026 10:00:10 PM
