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HDGabor

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HDGabor

Re: zmanindc post# 34413

Monday, 09/15/2014 1:18:00 PM

Monday, September 15, 2014 1:18:00 PM

Post# of 430690
Seriously, did you really think that FDA is acting based on management bonus schedule ...

No compromise will be happen. Not because of management and not because of the FDA. Appeal process (and all process at every authority) is not about negotiation.

Sponsor / client submit a request (appeal, application, etc.) and the authority grant or deny. That is it.

Short term we could see (with very low probability):
- DMEP approves the sNDA due to new study results (NEJM and ApoIII) since the rescission or
- grant ANCHOR's data on label
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