Replies to post #125873 on NanoViricides Inc. (NNVC)

[arvitar]

Where does it say the FDA required them to do efficacy studies?

Almost every company does preclinical efficacy studies to identify a lead. Those are distinct from the required "IND enabling" studies. One might refer to those studies to the non-expert public as studies to "support an IND", since without those studies, one would have no rationale for choosing one molecule over another as a lead.

Once a lead and several backups are identified, that's it for efficacy studies.

Next on the list are studies required by the FDA for an IND application. The list of studies required by the FDA do not included efficacy studies.

[Rawnoc]

....and yet nowhere does it say it was required. Frustrating, right?

"Should"
"To support"
"If known"

None of these mean required. Not even in Switzerland.