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Saturday, December 15, 2018 6:55:28 AM
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.
"I would rather have questions that can't be answered than answers that can't be questioned." Richard P. Feynman
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