NanoViricides Inc. (NNVC)

[robi-1-kenobi]

And once EbolaCide is found to be effective in animals, the FDA animal rule, the WHO, the NIH cannot deny us entry to Clinical Trials, first for safety in humans. How long will that take??? A couple of weeks! Remember, we are low toxicity EbolaCide!!! Then straight to hospitals

Changes - One key clarification here. The FDA Animal Rule relates mainly to animal efficacy studies, but does not preclude animal safety studies (see excerpt below). This means that GLP Regulatory Toxicity Studies will be required for EbolaCide2, with the additional time required for that (as little as 13 weeks but IMHO likely more).

While it might be argued that this would initially be for use outside the US, the FDA has enforcement responsibility for exports of pharmaceuticals meeting minimum requirements (I covered this in a previous post). In order for these requirements to be waived, either of 2 things must happen.
1. FDA must choose to exercise enforcement discretion (directly choose not to enforce US law - likely only in the most extraordinary circumstances)
2. Or NNVC would have to partner with a government body with ability to use their research authority to use EbolaCide2 in a study outside the US (e.g. NIH, WHO, maybe USAMRID - and we'd still have to convince them that whatever preclinical data we had in animals was enough wrt safety).

We all understand the seriousness of this outbreak and want to help.

But we can't help unless we determine what doses are safe and efficacious.

That means Reg Tox and PD/PK studies. This is not trivial, but an important essential reality.

LINK:FDA Animal Rule Guidance

VIII. Human Safety Information

1316 The Animal Rule neither replaces the need, nor establishes special requirements, for an adequate
1317 human safety database for drug development. The expectation is that drugs “will be evaluated
1318 for safety under preexisting requirements for establishing the safety of new drug and biological
1319 products.”84 FDA anticipates that the nonclinical and clinical safety development programs will
1320 proceed in a manner similar to that of drugs developed under traditional regulatory pathways.
1321 Some of the general principles include the following:

- Nonclinical toxicology, safety pharmacology, and PK studies should provide adequate safety data to support the initiation of human trials.
- Risk-benefit assessment and ethical considerations must guide the design of human trials at each phase of development.85 The regulatory and ethical complexities of establishing the necessary safety database should be discussed with the review division, preferably early in the drug development program.