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Friday, May 03, 2019 1:17:39 PM
"Assuming Novan had EoP2 meeting as planned at the end of Dec. 2018 and reported receiving minutes promptly FDA is now getting minutes out in about 60 to 90 days."
Page 8 of their 10-K filed on 3/27 says this:
"With the full results from this Phase 2 trial made available, we held an end-of-Phase 2 (Type B) meeting with the FDA in early March 2019."
Where did they say that they planned to have that meeting at the end of December? I missed it.
The first line of their 3/11 PR says this:
"Novan concluded an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) regarding SB206 for the treatment of molluscum. The Company has also received the written minutes from that meeting."
If I'm reading that correctly Novan had received the minutes of the end-of-Phase 2 meeting held in "early March" from the FDA by March 11th. If you have a minute please have a look at the source material and see if I have that right....it seems like a shockingly fast turnaround....well within the FDA's own "within 30 days" guidance and a whole lot less than your "about 60 to 90 days".
Am I misreading something?
But can it core A apple?
Yes Ralph, of course it can core A apple.
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