NanoViricides Inc. (NNVC)

[KMBJN]

It is a fact that they can produce a 200g batch, as this is exactly what was delivered to BASi to start testing.

The time to produce is estimated at around a week.

This is not pure conjecture. See some articles of studies that produce similar polymeric nanomicelles in 4-6 days:

http://www.ncbi.nlm.nih.gov/pubmed/16884896

http://www.ncbi.nlm.nih.gov/pubmed/19577643

http://www.ncbi.nlm.nih.gov/pubmed/22354326

2 days to produce and characterize the polymers, then another 3-4 to form and load the micelles with drug...


"Pure conjecture" is saying - "it took a year to produce 200g."

Closer to the truth is 1-2 weeks for the production - where does anyone get 52 weeks???



I have discussed multiple times why they may not be doing all the tox testing at once. I think the main reason is they haven't done the work required to do the tox analysis. From the 10-Q:

"We are also continuing to develop additional tests that are needed for analyses of samples from animals that will be generated during the safety/toxicology studies, and later in the human clinical trials. Such tests are needed for estimating a drug’s distribution pattern in the body as well as the time profile of the distribution. Such tests are also needed to decipher the metabolic fate of the drug. Since a nanoviricide drug is not a simple small chemical or an antibody, development of these tests is relatively complex, and is taking a significant amount of time. The work on FluCide continues, albeit at a reduced pace, due to the urgency of the anti-Ebola drug development program."


There is also the issue of scale-up, which they just don't have the physical space (hoods and such) to do in the old facility. It will be done at the new facility, whenever they get it ready, and have done some preliminary scale-up work:

"The Company has started certain initial safety/toxicology studies at BASi with the current product in hand. We need to perform further scale up and produce a much larger batch of the drug substance in order to perform the full suite of the safety/toxicology studies. The quantity required for these studies was estimated to be as much 2.5kg or more, because of the strong safety observed in preliminary studies. This scale-up will be performed at the Company’s new cGMP-capable manufacturing facilities in Shelton, CT."

"The Company is currently performing process development and scale up studies on its FluCide drug candidate in its existing facilities. This activity is comprised of three parts: (a) Scale-up and characterization studies of the selected broad-spectrum anti-influenza ligand in FluCide; (b) Scale-up and characterization of the nanomicelle-forming polymer in FluCide; and (c) Scale-up and characterization of the FluCide resulting from chemical conjugation of the ligand with the nanomicelle. The scale-up studies were necessitated to be performed at this early stage of our drug development because of the extremely high safety of FluCide that resulted in a very large quantity requirement for the GLP Safety/Toxicology studies. The limitations of the current laboratory facilities impose that we produce these materials in multiple batches at present, resulting in extended production and characterization time periods. We were able to perform production of 200g batch in our current facilities. This quantity allowed us to initiate certain safety studies."

and

"We have been actively studying different chemical processes and routes of synthesis of the backbone polymer, the ligand, and the nanoviricide drug itself, which is a chemical conjugate of the two. The objective of these studies is to develop pathways that will allow industrial manufacturing scale production of a well-defined drug substance, so that multiple batches will produce consistent product. Our studies also involve the development of methods of chemical and physical characterization of the materials at various stages in the entire production process."

They can already do 200g, but are working on the processes for scale-up.

So no, not pure conjecture. It's a pretty good guess that they can produce 200g batches in a week or two at the old lab, and are currently working on improving the scale (which they can only do in the larger space of the new lab). They still have more work to do on toxicity analysis methods and scale-up of the process at the new lab before they can continue with the bulk of the tox work.