Replies to post #84508 on NanoViricides Inc. (NNVC)

[robi-1-kenobi]

I agree Dr. Hari - my main worry is also that it takes NNVC too long to get into the clinic.

The balance is speed vs. going through all the paces the FDA and other WW reg bodies require.

I know of instances where specs were held more tightly than needed for safety and efficacy and that leading to poor process capability and consistency and repeatability in processing batches.

But CDER in FDA seems to be on the warpath of "consistency" and can greatly slow or stop you in your tracks if you don't meet their expectations - sometimes arbitrary and unrealistic expectations without consideration for practical, common sense balance of good enough for safety and efficacy vs. their (CDER) idea of perfect from a consistency standpoint.

So they are walking a fine line here. It appears that they feel they need to wait for scale up to make the Tox batches and processing more consistent with the planned further scaled up processing of batches they will make for clinical and commercial use.

There are a lot of judgement calls here and NNVC seems to be operating very conservatively. I hope not too conservatively.