NanoViricides Inc. (NNVC)

[changes_iv]

I have a question. When possible, please watch the video and give us your opinion as to why would Dr. Seymour states the following, "...and by the way, I'm sure that when you think of human trials for drugs you think of hundreds of millions of dollars, and years of time. Well in this case, because the disease only lasts a week...two weeks, that it is possible to complete human trials in the space of a few short months...four parts to the human trials"?

Fast forward the video to 19:00 minutes (for some context) or by 19:50 minutes to listen to the particular statement by Dr. Seymour.

Pre-IND Meeting was held with the US FDA on March 29th, 2012. http://www.nanoviricides.com/press%20releases/NanoViricides%20Announces%20Successful%20Pre-IND%20Meeting%20with%20the%20US%20FDA.html

Notice the video was published Jun 28, 2013, about a year later.

Press Release Apr 2012

FluCide, which has the most clinical data of all of NanoViricides drugs, works on the same principles as the rest of the company’s platform.

The company said it received comments and exchanged a list of questions with the FDA prior to the meeting, and believes the health regulator has given the company a good roadmap for advancing the drug toward an "investigational new drug" application.

"Because of the novelty of the technology and approach, we requested this pre-IND meeting even before performing certain customary safety/toxicological studies," NanoViricides said in a statement.

"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."

The FDA reviews the IND application for safety to assure that research subjects will not be subjected to unreasonable risk. If the application is cleared, the candidate drug usually enters a Phase 1 clinical trial.

source: http://en.wikipedia.org/wiki/Investigational_New_Drug

Possible TYPE OF IND: Treatment IND, submitted for experimental drugs showing promise in clinical testing for serious or immediately life-threatening conditions while the final clinical work is conducted and the FDA review takes place.

Why would Dr. Seymour make such statement when the timeline for drug evaluation depends on the US FDA? His statement does not follow any Timeline for Drug Evaluation seen on the graph (see http://en.wikipedia.org/wiki/File:Drug_Evaluation_Process.jpg )

I will be away for the day and will not be back until tomorrow Wednesday. Perhaps I may have missed other PRs between Mar 2012 and Apr 2013 that explains Dr. Seymour's statement. Thank you in advance for your replies/observations.

Nanoviricides, Inc. patented bio-nanotechnology is unprecedented. The nanoviricides are not vaccines, but rather therapeutic drugs, which actually destroy the virus structures as opposed to enhancing the immune system of the host to fight off a particular a virus.