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KevGee59

10/01/19 10:09 AM

#217076 RE: sharinky #217062

I was actually thinking that the risk of the ADCOM is more so on those not wanting Amarin to succeed. If panelists are familiar with the data...and I assuming they will be. An AC could give Amarin a much wider label than they may have gotten without an AC.

MRC's and others' influence on ADCOM (if any) could be a HUGE Backfire...

It would be another huge black eye for the FDA if AC panelists recommend a very wide label...and the FDA doesn't respond affirmatively. After all...the FDA needed 'experts' in the field to help them determine label through AC. Even so...that they waited until the last minute to call one.

I'm sure someone with more technical writing skills could put this more eloquently than I could.

KG ;)