The overall objective of these studies will be to help select clinical drug development candidates for the treatment of influenza virus in humans
This was supposedly done several years and we were told they were in Tox with Flucide. If they are still selecting a candidate for treatment in humans, they will need to restart Tox and if the specific "formula" has changed, will need another FDA meeting to get Tox guidance.
This isn't just kicking the can down the road, it's replacing the can that was supposedly close to Tox completion and starting over.
The in vitro studies will evaluate the efficacy and potency of the Company's nanoviricides anti-viral agents against a panel of influenza A and B virus infection of different types of cells, including human bronchial epithelial cells. The in vivo studies in small animals will evaluate the safety and efficacy of the Company's nanoviricides to protect against severe H1N1 influenza infection.
I guess the previous "outstanding" results in this exact area weren't sufficient.
It seems to me that NNVC would not have entered into this agreement without some certainty in their ability to scale up to the required amounts of nanomicelles needed for tox testing. This Flucide news came out of left field for me.