Replies to post #138017 on NanoViricides Inc. (NNVC)

[loanranger]

Some questions need long answers. The parts of that that I understood made sense to me...probably more sense than the question itself.

"The FDA doesn't define required percentages. Everything measured will always be less-than 100%."
"They want to see that the percentage and types of those impurities are reliably reproduced between different batches of the material."

Thanks...

[KMBJN]

I'd imagine a characterization of particle size, and reproducibility of size-distribution.

From the 10-Q:

We have developed strong chemical manufacturing process controls that enable us to produce the backbone polymers with highly restricted and reproducible molecular size range. In fact, we have achieved highly reproducible and scalable processes that have yielded the same polymer molecular sizes across production scales from 10g to 500g. In other words, we are now able to control the length of the backbone polymer to within one monomer unit, irrespective of production scale (at least up to about 1 kg scale).

Guess what that means for the size distribution of the resultant nanomicelles made from said uniformly sized backbone polymers?

They say reproducibly making the ligands and scaling up that process should be relatively easy.

The key could be reliably attaching the ligands to the functional groups of the backbone polymer / nanomicelle with some uniformity, or less likely getting the nanomicelle to form uniformly with the functional groups evenly spaced out. I'm not sure how many ligands need to be present and how evenly spaced in order to attach the numerous viral coat proteins and tear it apart.

Seymour made it sound like it was "shake and bake," but that appears not to be the case. Someone else may have said something similar, but that information source is also unreliable.

From the patent https://patents.justia.com/patent/20100008938:

The present invention provides biocompatible comb-type polymer molecules, comprising a hydrophilic backbone having branch-point moieties, and hydrophobic branches attached at these branch-point moieties. The invention provides aqueous suspensions of polymer aggregates formed from such polymers

The structure comprises a backbone formed of alternating branch-point moieties B and hydrophilic, water-soluble polymer blocks A. Hydrophobic side chains C and ligands Z are attached to the branch-point moieties.