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bradfordbros

12/14/18 6:19 PM

#251350 RE: loanranger #251341

Minutes of a meeting are just a recording of the event and Ipix has it’s answers already or when the meeting takes place. Correct?

PlentyParanoid

12/15/18 6:55 AM

#251382 RE: loanranger #251341

I concluded some time ago that when it comes to FDA very few things are written in stone. But let me try.

1. Generally: No reason to think that FDA would come up with new 'issues' during waiting period. But I can imagine one: if new information develops during the 30 days period - for instance, another trial reports unexpected grade 4/5 (5 is death, BTW) adverses effects for a similar drug.
2. In my opinion second EOP2 would require new information submitted to FDA in response to possible issues pointed out by FDA. In this context new information usually means that some additional lab or trial work needed to be done.
3. It will take a bit more than haggling to change FDA decision.