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Re: arvitar post# 144697

Friday, 09/04/2020 9:38:39 AM

Friday, September 04, 2020 9:38:39 AM

Post# of 146291

If NNVC were to start full tilt today, running a candidate through all the tox and CMC studies required to complete an IND package for an oral covid drug, it would take them 12-18 months if they had no problems.



I don't think that is true. [Bold claim, I know, considering NNVC has not gotten a single IND in the last 15 years].

From the PR, CMC is complete, small animal tox is done (but not formally), and in vitro tox and efficacy have been shown against non-deadly bCoV that use ACE2.

Subsequently, the Company has completed CMC ("Chemistry, Manufacture, and Controls") studies that would be required for an IND ("Investigational New Drug) application to the U.S. FDA. The Company is also in the process of drafting sections of an IND for COVID-19 drug candidate.



Once they declare final candidate, they would then do formal tox and repeat CMC. Warp speed - hah, maybe we could get a Covid trial going next spring some time? We'll see how quickly they can put things together.
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