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Re: arvitar post# 141328

Tuesday, 03/26/2019 6:09:38 PM

Tuesday, March 26, 2019 6:09:38 PM

Post# of 146240
"In fact, it doesn't even make sense for NNVC to have requested the meeting with the FDA, since they aren't the ones developing a compound; Theracour is."

Does the FDA require that the applicant for an IND possess the IP for the drug? This FDA web page suggests that they don't:
"FDA's role in the development of a new drug begins when the drug's sponsor (usually the manufacturer or potential marketer), having screened the new molecule for pharmacological activity and acute toxicity potential in animals, wants to test its diagnostic or therapeutic potential in humans."
From "Investigational New Drug (IND) Application"
https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/investigationalnewdrugindapplication/default.htm

What entity has "screened the new molecule for pharmacological activity and acute toxicity potential in animals"? NNVC via BASI, right?


"Which makes the PR seem shady."
Some would see that to be the case no matter what it said.

But can it core A apple?
Yes Ralph, of course it can core A apple.

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