Replies to post #100607 on NanoViricides Inc. (NNVC)

[robi-1-kenobi]

I think they did feel pressured to begin with partial Regulatory GLP Tox now. This pressure wasn't just from this board though. There has been stock price pressure and shareholders directly contacting the CEO.

There was a posting not long ago on Investorvillage from what seems a reliable poster (S_Colton) that stated Dr. Seymour said they were going to make material for GLP Tox in the new lab facilities.

That was also their original plan before the lab completion was delayed.

I think that was their ideal plan all along. So (IMHO) I think the following will be the compromise - testing of materials from both labs.

This ticks off a few boxes from the standpoint of meeting FDA (and other Int'l Reg Bodies) expectations and requirements. The testing should include materials made in pilot scale batch sizes (~1 tenth the size of planned commercial batch sizes) and meet some aspects of cGMP. This is the next size up - 1 kg scale - to be made in the new lab with some cGMP controls. Starting with some material from the old lab can check off some of the FDA requirements and reduce the time and materials needed to complete the study with materials from larger batches made in the new lab with better cGMP controls.

This is speculation on my part, but the way I would approach it from my understanding of the regulatory requirements and project timeline pressures.