NanoViricides Inc. (NNVC)

[arvitar]

You're absolutely right about questioning whether NNVC had a pre-IND meeting. I was wrong to suggest the PR I linked to used the words "pre-IND meeting".

But, I think I might be right in saying this PR is about a pre-IND meeting:

On March 26, NNVC PR'd they had requested a pre-IND meeting:
https://www.prnewswire.com/news-releases/nanoviricides-has-requested-a-pre-ind-meeting-with-the-us-fda-300818336.html

Then on Jun 3, NNVC PR'd they received "Favorable FDA Comments on Its Pre-IND Application for the Lead Drug Candidate"
https://www.biospace.com/article/releases/nanoviricides-has-received-favorable-fda-comments-on-its-pre-ind-application-for-the-lead-drug-candidate/


I don't know whether that's just bad English on NNVC's part, but they're not going to get comments from the FDA on what they submitted in a pre-IND application, unless they actually had a pre-IND meeting with the FDA.

If NNVC had no real data to submit in their application, the FDA would have only granted a "written response only" (WRO), in lieu of a face-to-face or teleconference pre-IND meeting. I think that's what NNVC is trying to communicate in their PR, the WRO comments they received from the FDA, which means a WRO was their pre-IND meeting.

What NNVC describes in their PR is consistent with them having only submitted a description of what they plan to do as their pre-IND package, rather than anything substantive:

"In particular, the Agency has agreed that the Company's strategy for drug substance and drug product acceptance criteria is adequate. The Agency has further agreed that the IND-enabling non-clinical studies proposed by the Company are generally adequate. The US FDA also said that the proposed design of the IND-opening human clinical studies appears reasonable at this time."