NanoViricides Inc. (NNVC)

[seeker_of_value]

Therapeutic index question answered by Dr. Seymour

I could not resist asking the following question to Dr. Seymour. So my question and his answer are given below.

Dr. Seymour,

I read your letter about why we need so much drug for the TOX tests. It is unbelievable that FDA does not impose a limit on the amount of drug that needs to be dosed for TOX. For example, they could limit the max TOX test dosage to say 10 times of expected therapeutic dose. Looks like they do not have such limits since most drugs do have at least some side effects. Have you tried to request FDA to make an exception in case of Nanoviricides since this drug seems to have no known side effect and thus lethal dose may be very difficult to determine. If a personal meeting is hard to obtain may be they will answer your written request.

Thanks for the hard work by your team.

Best regards
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Dr. Seymour's answer

It is rather bizarre, isn’t it?

We’re exploring other approaches with the assistance of our FDA consultants

In the meantime, the Aussies could care less, so by going there first, we can approach the FDA with solid human data that just may make a difference

This is the problem with any brand new technology

It’s all new ground and the FDA is a very risk-averse organization

The Thalidomide experience of 53 years ago still drives their thinking

Sincerely,

EUGENE SEYMOUR, MD, MPH