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Re: arvitar post# 138033

Saturday, 02/24/2018 11:25:00 AM

Saturday, February 24, 2018 11:25:00 AM

Post# of 146210

Diwan was reported to have said at the 12/8/2017 annual meeting that NNVC was schedule to have a pre-IND meeting within 6-8 weeks from that time:
http://www.siliconinvestor.com/readmsg.aspx?msgid=31384272




I should have mentioned: It also doesn't make sense to have a pre-IND meeting with the FDA until some subset of the IND-required tox studies have been completed and those data are in hand.

NNVC has not said they've even started any such studies, let alone even identified a lead candidate to discuss at such meeting. They've also said in their recent 10-Q that their funds are insufficient for doing such work.

So it's possible NNVC has these pre-IND meetings with the FDA that are entirely useless because they go without any tox or CMC data (or even a lead candidate to discuss). That wouldn't be good, since it would destroy their credibility with the FDA.

Or it's possible they don't really have these pre-IND meetings with the FDA.

Given where NNVC is today, and the limited information they've made available to the investing public, there isn't a basis for coming to any regulatory, scientific, or technical conclusions regarding what NNVC has actually accomplished, or what problems they have that have prevented them from moving forward at 13 years and spending $80M.

A casual stroll through the lunatic asylum shows that faith does not prove anything. Friedrich Nietzsche

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