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Agree. Reasons why CP being the reason for

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Mellowmood77 Member Level  Thursday, 09/19/19 04:19:58 PM
Re: Biobillionair post# 215197
Post # of 220222 
Agree. Reasons why CP being the reason for the ADCOM makes sense:

1. Amarin’s FOIA requests
2. Amarin responds to MRC’s CP
3. No solicited information caused ADCOM
4. CP filed late, ADCOM also filed late.
5. Guidance released by FDA stipulating on gaming CP’s.
6. CP’s were profound, well written, articulate and convincing if actual facts are not known. Complete BS, but enough to force the FDA’s hand by mandate.

Now let’s wait and see if FDA shows how all powerful they are and reverse ADCOM with the new CP guidance issued. I’m not holding my breath but I don’t see it as an impossibility like some people.

Also it’s possible the CP caused internal rifts in the FDA and they could not decide for themselves and decided to hold ADCOM as Raf has suggested.

But all signs point to the CP as being the cause of the ADCOM... other wise why in HELL not schedule one sooner? It’s not like this drug causes limb loss! It’s just fish oil! :)


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