Replies to post #34610 on NanoViricides Inc. (NNVC)

[Ubertino]

I thought they WERE already in FDA dialogue - like a year or more.

[BonelessCat]

Began preliminary dialogue with FDA 4 years ago. What NNVC is doing now is based on what the FDA wants to see.

It's all on the FDA website if you know where to look.

[BonelessCat]

Eugene Seymour, MD to me

Usually, people meet with the FDA for a pre-IND meeting

There, the parameters are set for what's needed as to number of patients in the various Phases of the human trials. In addition, all of the studies that will be submitted in support of the IND are reviewed and guidance given. Dr. Diwan has publicly stated that we plan to file for a pre-IND meeting sometime either in the last quarter of this year or the first quarter of next year. Then, the FDA gives guidance for the timing of the IND filing for the Phase I study based on their review. Fortunately, companies working in the oncology arena will in all likelihood get to the FDA first and will help clear the path for us. The person who posted that opinion as to the timelines obviously doesn't understand the process. That's clear when he says that the vaccine company is "barely in Phase I trials and just beginning to start on a few humans". You can't "barely" be in humans. You are either in or not in. Looking at INO's press releases suggest that they have completed studies on 2/3 of their enrollees in the Phase I trial. These studies included safety, dose escalation and immunogenicity studies on these initial enrollees. If their results are good, I suspect that they would be able to start large scale studies for efficacy before the end of next year.

Assuming that we file for our pre-IND meeting before the end of Q1 next year, it would not be unreasonable to assume that we would be able to file our IND six to 12 months after that meeting. The caveat is that we don't know the response of the FDA. However, to suggest that we won't start our Phase I human studies for a "very very very long time from now" is completely disingenuous and doesn't take the facts into account

I hope that this is helpful

Sincerely,

EUGENE SEYMOUR, MD, MPH
Chief Executive Officer
NANOVIRICIDES, INC
Nanotechnology-based targeted anti-viral therapeutics
http://www.nanoviricides.com
[e-mail]
310-486-5677