NanoViricides Inc. (NNVC)

[changes_iv]

You've said that Nanoviricides, Inc. has been doing toxicology studies for nearly eight years. I'll take you at your word on that. The part of those eight years toxicology studies that corresponds to FluCide, in my opinion, are now part of the IND upcoming submission to the FDA. I'm speculating here based in part on the following PR excerpt:

"We believe that the guidance we received goes beyond FDA guidance documents, and is more specific for our drug candidate, NV-INF-1.

"The company will now plan and execute the studies identified based on this meeting."

source: http://www.proactiveinvestors.com/companies/news/27192/nanoviricides-says-pre-ind-meeting-with-fda-for-flucide-successful-27192.html

We read a post from the BigKahuna, "... -IMO, the biggest thing, Anil was able to develop the MERS solution in less than a week. Less than a week for the type that will be tested in EU is pretty amazing and beats the 3 weeks of the rapid in field technology they previously talked about..."

This week we read, "The Company has also started sub-kg scale production of our injectable FluCide™ anti-influenza drug candidate at its current facility. Safety and toxicology studies of our injectable and oral FluCide drugs are estimated to require very large quantities of the drugs, because of strong safety data evidenced from our in vivo (animal) efficacy studies to date. The Company will be able to initiate GLP Safety/Toxicology studies (“Tox Package”) studies of our injectable FluCide drug when the requisite large amount of drug substance is produced."

NanoViricides Progressing on Schedule to Build New Clinical Scale cGMP Production Plant
Published on August 20, 2013 at 8:26 AM

NanoViricides, Inc. (the "Company") reported today that the renovation of the facility in Shelton, CT, to build its new clinical scale cGMP production plant is progressing on schedule.

The Company has recently signed confidentiality agreements with both Public Health England (PHE-UK) and the Lovelace Respiratory Research Institute, New Mexico, USA (LRRI). Both of these institutions have the ability to perform further testing of our FluCide drug candidates against additional influenza viruses including H7N9. The Company intends to perform our remaining IND-enabling studies of FluCide at these institutions. Keyword here, "remaining".

Nanoviricides, Inc. will soon start/finish producing the quantities of injectable FluCide™ in sub-kg scale and ship them to the two key collaborators. The studies will begin in earnest with the injectable FluCide. Once injectable FluCide is shipped to key collaborators, production of the oral FluCide will be next to start, soon enough it will finish production and will be shipped to the key collaborators as well.

The two key collaborators, Public Health England (PHE-UK) and the Lovelace Respiratory Research Institute, New Mexico, USA (LRRI), will progressively perform the remaining IND-enabling studies of FluCide and feed Nanoviricides, Inc. with initial tox studies results (4Q 2013) and that in turn will enable Nanoviricides, Inc. to prepare IND for submission to regulatory authorities (4Q 2013), all in the "nick of nano-time" to meet the projected Milestones.

Toxicology studies for FluCide, of key collaborators, continues and completes in 1Q 2014. The final tox studies results are fed to Nanoviricides, Inc. Subsequently, IND is finalized and submitted to the FDA 1Q or 2Q 2014. I am speculating here but this is how I believe these key events will pan out.

Projected Milestones -
-cGMP/R&D Center Shelton CT integration completes ~ 4Q 2013
-Commision new cGMP plant ~ 4Q 2013 (equipment moved in/3 identical test batches)
-Receive initial results toxicology studies FluCide ~ 4Q 2013
-Prepare IND for submission to regulatory authorities ~ 4Q 2013