Replies to post #141331 on NanoViricides Inc. (NNVC)

[arvitar]

Does the FDA require that the applicant for an IND possess the IP for the drug?

No, as you point out. They require that the Sponsor does this. "Sponsor means a person who takes responsibility for and initiates a clinical investigation." https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=312.3

The FDA is going to review the application for the pre-IND meeting, and they'll want to check if the person/entity claiming to be the Sponsor is really the Sponsor.

Maybe the fact that NNVC has no rights to the compound, and Diwan owns another company who does have rights, where that other company is the only entity gaining to benefit from FDA approval, and Diwan is the responsible person for both the applying entity NNVC, and the other entity who has the only rights to commercialize, will escape the FDA reviewers. I don't think so, but that is only my opinion. Any smell of the applicant not being completely forthright about even the smallest detail won't fly with an FDA reviewer. They commonly raise red flags for far less.

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

Those entities would include BASI, Theracour, and all of the academic labs who were paid to do contract work. All through NNVC as you point out. We don't know exactly what Diwan will include in the pre-IND meeting package. Presumably he'll avoid focusing on Theracour's data if he wants to avoid raising red flags.


Typically, almost universally, one doesn't have a pre-IND meeting until one has completed a number of the FDA-required GLP tox studies, as well as most of the CMC chemistry work. The point is to have the FDA look at your actual data you intend to submit, including your CMC data, to give you some guidance regarding whether or not you're going to have any problems.

It's senseless to have the pre-IND meeting without any of those data in hand. I doubt the FDA would agree to it, and it would not serve any purpose is they did have the meeting. Several non-required, non-GLP, tox studies would be useless.

[arvitar]

I said:

"They require that the Sponsor does this."

By "this", I meant that the Sponsor files the application.

[JG36]

There's no requirement that NNVC own the IP. They've always been the front man for Theracour/AllExcel. The profits go to Theracour/AllExcel, of course. Indeed, when NNVC runs out of money some time in the next year Diwan has the option of just shutting down Theracour/AllExcel and retiring on the money those companies have in the bank.