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Re: KCSVEN post# 14446

Friday, 09/20/2013 2:22:53 PM

Friday, September 20, 2013 2:22:53 PM

Post# of 428162
If the Adcom is comprised of practicing doctors and not experts on chemistry, how could they actually have a say on NCE?

Seems like one of two things is going on
1) Since they have not already assigned NME, then they are waiting for Anchor approval to assign NCE given that the new indication supports NCE

2)They are waiting on NCE post Adcom as the Adcom may really matter relative to near term approval or post Reduce IT approval.

Seems to me the former is the much more likely possibility given everything that continues to be discussed here re SPA, clean day 74 letter, FDA's desire to get outcome data, etc...
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