NanoViricides Inc. (NNVC)

[robi-1-kenobi]

I hadn't seen Puffer's thinking had changed, but thanks for the update, Sarbreur.

However, it doesn't change my thinking based on my reading of the risks involved with FDA accepting comparability of material produced in the existing lab with future clinical batches made in the new lab and the risk-averse nature of NNVC decisions to date.

They said scale up was "successful" in a December PR for the Annual Meeting - "the Company has successfully performed studies on the scale up of synthesis of FluCide."

This is a long time to be making materials even if it is in the old lab.

Besides, they already made a demonstration batch of the base viricide carrier at the Grand Opening of the new lab. Not much more (relatively) to do to add the ligands.

If they are so close, I would anticipate NNVC using material from the new lab to reduce the chance of rejection of comparability to clinical materials. As Dr. Seymour said, "There are no shortcuts. It must be done right the first time." Post 96884.

I think you are correct that NNVC is planning to deliver test materials to BASi in blended batches together upfront. The Annual Report stated they will be blending batches. But again, IMHO, that doesn't mean they won't add on blended batches from the new facility to study separately in parallel or blend those with the existing materials as a new/old blend, or other options to protect clinical comparability.

In all this I could be wrong. But it is my best guess based on all the available input.

Puffer's latest thinking on IV is that ALL of the material
for tox will come from the existing facility and that it will
ALL be delivered to BASi upfront. Apparently Diwan's preference
to do it that way. He thinks they will start tox by end of
next month and also thinks scale up in the existing facility
has already been accomplished. (I think there was a PR a few
months back already stating that scale up had been successfully
accomplished).