NanoViricides Inc. (NNVC)

[robi-1-kenobi]

I may be incorrect wrt ZMapp GLP Tox testing based on your reference, Changes. It was my impression that there was GLP Regulatory Tox Safety testing done. This seems to say they were just starting it - either for the portion on large animals or for all of it.

The drug had never before been tried in people, though it and some predecessor drugs had been tested in monkeys, showing some effectiveness. Mapp was only now gearing up to start the larger animal toxicity studies typically needed before testing it in humans, with an eye to doing the first human safety studies in healthy volunteers next year. For that reason there were very few doses available when the Ebola outbreak started.

The second reference is mistaken reporting on the part of Forbes. The Animal Rule guidance is clear and I quoted it in a previous post (see quote below). Safety testing is still required.

But the Animal Rule must not have been followed. Mapp did not go through FDA. The Department of Defense must have overruled.

That puts more importance on the speculation of Partnerships with NNVC e.g. USAMRID.

Partnerships with agencies with research authority is the 2nd exception to following US law enforced by FDA (as I also pointed out in previous posts). This is what Mapp most likely did and provides a potential path for NNVC to abbreviated safety testing without full GLP Regulatory Tox.

I am a little surprised (and possibly wrong about all my safety posts) if Mapp did not have at least some GLP or extensive non-GLP animal safety data to provide assurance to DoD prior to use - even though it seems they did not start the full GLP Regulatory Tox testing.

This will be my last post before my work week starts - just a heads up I will not likely have time to post for a while.

VIII. Human Safety Information

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