NanoViricides Inc. (NNVC)

[robi-1-kenobi]

Important new report on site of TOX manufacture from web search (Google: "Flucide Program").

If the source's statement can be believed, he received an email from Dr. Seymour with this information: the Flucide materials for GLP Regulatory Tox are going to be made in the new facility. He posted this on Aug. 25.

If true, I would think this pushes the start of Tox toward the end of this year or early next year. I am figuring about 9mo to 1 year to report Tox results and another 3-6mo or so to file a CTN/CTX with Australia TGA and EC/IRBs. So maybe Q1-Q3, 2016 to start FluCide clinical trials.

I have come to believe this was going to happen anyway (at least use of supplemental FluCide from the new facility - see my previous posts) based on conservative approach of NNVC management and sensitivity of CDER in FDA for similar clinical manufacture in particular for nano materials. Note that NNVC plans to leverage the Australian Phase I/IIb clinical studies for the FDA IND submission.

I have already greatly reduced my NNVC stock holdings waiting for a lower share price due to extended timelines. I am holding a little in case there are bounces in SP on potential announcements on Ebola partnerships or other Ebola developments. Just a long road here. I am not abandoning NNVC, but I am making much better returns short-term elsewhere. I am fine with the potential risk of losing a bit of any upswing in SP. I balance that with opportunity cost of tying up too much in NNVC now and the hope of buying at lower share price.

Msg 1660 of 1687 at 8/25/2014 2:42:21 PM by S_Colton

FluCide Program
I just got word back from ES that, although the old plan was to make tox study FluCide in the old facility, the new 5x quantity requirement has made the old facility a limitation. They’re moving in this week to Shelton, and the output of tox material should go up by a large multiple.

Zinc was right...the company is relying on the new facility to be up and going to expedite FluCide tox testing.

Expect an update in the forthcoming 10K. I don't know when that will come out, but last year (according the NNVC's website) it came out on 10/1...so five weeks?