Replies to post #79664 on NanoViricides Inc. (NNVC)

[Puffer]

Actually it called for Q4 '14 or Q1 '15, though I think 2015 is more likely.

The schedule released called for phase 1 trial to begin in 2015.

[KMBJN]

I'm talking about production for tox studies, to be done from scale-up at existing facility, we have been told.

Production of FluCide in new cGMP facility is for clinical trials.

From the 11/13/12 PR announcing BASI for tox testing: "The Company anticipates that it will need very large quantities of the drug candidate for these “tox package” studies. The Company has found FluCide to be safe in animals at large dosages, and will need to determine certain safety and toxicology limit parameters. The Company is currently performing scale-up studies in order to produce the necessary quantities of the drug candidate."

From a 12/10/12 PR: "The Company ... is performing further studies that are necessary before producing the large batches for the Safety and Toxicology ("Tox Package") studies. The Company is also developing a scale up laboratory at its current site to enable production of this drug candidate in the large batches needed for these Tox Package Studies. "

From the last annual report 9/30/13: "While we have made significant progress in this scale up program at our current facility, certain key equipment pieces that we need are still on back order at present with certain vendors. After these equipment pieces arrive, we will need to set them up, validate them and then use them for the operations they are intended for. This continues to be an item causing delays in our goal of making sufficient quantities of FluCide for the tox package study and it is outside of the Company’s control."

They told us when announcing the start of non-GLP / pre-IND enabling tox on 10/7/13: "In those efficacy studies of FluCide, no safety or toxicology concerns were observed. As a result, the required quantity estimated for GLP safety/tox study is much larger than our current synthesis capability. The Company has undertaken process development, scale-up, chemistry optimization and control program to enable large scale synthesis of FluCide in a reproducible manner. This work is currently in progress."

From the 11/18/13 PR announcing 3Q results: "The Company is currently performing scale up studies on its FluCide drug candidate in its existing facilities. Upon scale-up, we will be able to produce the quantities of materials we need for the GLP Safety/Toxicology study of the injectable FluCide drug. We intend to begin the GLP Safety/Toxicology study as soon as feasible."

From the 12/2/13 announcement of results of non-GLP tox: "A critical step in FluCide drug development is the ability to produce clinical scale drug product. The Company has previously reported that the renovation of its facility in Shelton, CT, for its new clinical scale production plant is in the construction phase with projected completion during Q1 2014. The Company is performing certain scale up studies for manufacturing FluCide at its current facility."

As you can see, "scale-up" at existing facilities has been apparently been going on for at least 14 months and probably longer. It would be nice to have an update, other than "scale-up" is continuing, which I think has been in about 20 PRs in the last year+.