NanoViricides Inc. (NNVC)

[Puffer]

When that is the case it's because the efficacy was so high and in such a high proportion of patients that statistical significance of efficacy was established in the Phase I despite the very low number of patients.

So IF the results are good enough in Phase I, only the Phase I has to be done in flu season. The Phase IIA can be done after the season in such cases. (so there would be no need to wait for the next flu season to complete the PhaseI/IIa.)

Phase I safety will involve giving healthy subjects the drug (no flu season required and no efficacy established). Phase IIa will involve infecting subjects with the virus and then treating them. Phase IIb will require a flu season somewhere.

At least that is my understanding.