Replies to post #84481 on NanoViricides Inc. (NNVC)

[robi-1-kenobi]

Thanks, daBoze. Yes they hired Hahn for design and construction of the new facility as he is an expert at design, architecture, engineering, and construction of laboratory and manufacturing facilities.

These are great skills in helping you build the facilities where your scaled up processes will reside.

But they are not necessarily the same skills as needed for design the individual reactors, impellers, etc nor to run the DOE and RSM experiments needed to hone and optimize the process equipment and parameters to produce the nano micelle product material you want on a larger scale.

I haven't seen any announcements on consultants on that front. Frankly, as Dr. HS said, this is a relatively new area of technology and very unique. Still, process optimization techniques can be tailored with expertise and effort.

These challenges, along with consistent processing steps, process capability, meeting specifications, and meeting consistent characterization requirements of materials (what goes into the FDA CMC section of the IND) seem to be the reasons scale up is taking longer than expected.

IMHO - I still see them meeting a Q2 (June) date for starting GLP IND Toxicity testing - with the possibility of an surprise to the upside. I am not basing this on any special knowledge of the process or progress, but on Dr. Seymour's stretch goal of Q4 clinical trials still being in play.