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Biobillionair

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Biobillionair

Re: Atom0aks post# 208442

Tuesday, 08/13/2019 11:11:35 AM

Tuesday, August 13, 2019 11:11:35 AM

Post# of 427139
I think Amarin could be wrong regarding delayed PDUFA date, this can be clarified and communicated to stakeholders. Woodcock would have to sign off on PDUFA delay and I don’t see this happening....

It’s totally acceptable for the FDA to hold an Ad Com after PDUFA date and “some” label expansion...

Amarin can get this clarified by contacting Dr. Woodcock...hopefully hear something by the end of the day on this......

If Amarin asked the direct question she would provide an answer:

I am not able to discuss anything about an individual firm’s interactions with the FDA outside of their authorized representatives. Janet Woodcock




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