Monday, December 05, 2011

NNVC - maturity knocking

In 2009 I forecast that NNVC could be a triple digit stock (over $100/share) by 2014. That forecast was based on their game-changing anti-viral technology that has the potential to eradicate the most heinous viral diseases known to civilization. No hyperbole, just facts.

It takes time and money to go from here ($0.70/share currently) to there. They have the money now and we have the time.

NanoViricides, Inc. Announces That It Has Submitted a Pre-IND Meeting Request to the US FDA For Its Anti-Influenza Clinical Drug Candidate, FluCide™
Submission Represents a Major Advance for the Company



WEST HAVEN, Conn.--(BUSINESS WIRE)-- NanoViricides, Inc. (OTC BB: NNVC) (the “Company”) announced today that it has submitted a pre-IND Meeting Request to the US FDA. The Company has requested an initial meeting with the US FDA to review the Company’s proposed strategy and plan for conducting safety/toxicology studies and human clinical trials required for approval of its anti-influenza clinical drug candidate, FluCide™ (i.e. NV-INF-1).

“This submission is a major milestone in the Company’s program to obtain US FDA approval for FluCide™,” said Eugene Seymour, MD, MPH, CEO, adding, “FluCide has demonstrated excellent efficacy and safety when treating influenza infections in our animal studies. We anticipate similar strong results in humans when the drug becomes available for human use.”

The Company has submitted required introductory documentation with the meeting request letter in consultation with the Company’s regulatory matters consultants, viz. the Biologics Consulting Group. The Company plans to submit additional briefing documents at least thirty days before the FDA meeting, in compliance with the FDA guidelines.

This pre-IND meeting request submission follows the Company’s recent announcement that it has chosen a clinical candidate, NV-INF-1, in its anti-influenza drug program (FluCide™) to develop for regulatory submissions both domestically and internationally. It is estimated that there are about 50 million cases of influenza annually in the USA alone, and about 250,000 patients are hospitalized for influenza. The Company believes that a single course of therapy that can be easily administered by a medical office is likely to be feasible for out-patients, with no additional follow-on treatment necessary. This expectation is based on the following results from its animal studies: (1) the extremely high treatment effectiveness in inhibiting the cycle of infection, virus expansion and spread of infection and, (2) the significantly long lasting effects of the drug treatment after the drug is discontinued. In addition to out-patients, the Company also plans to develop an indication for hospitalized severe cases of influenza.

The Company has recently announced that it is working on developing cGMP (“current Good Manufacturing Practices”) manufacturing capability for the production of its drug candidates. cGMP manufactured materials will be required when the Company is ready to file an Investigational New Drug (IND) application to the US FDA.

10 comments:

Anonymous said...

It's funny how a post on nnvc a year or two ago would have generated all kinds of buzz but nada today.

The big news today barely budged the sp even after the severe beatdown over the past 6 months.

angelo851 said...

Allan,

Thank you for following up on NNVC. I purchased several thousand shares between $1.50 and 2.20 a share from following your posts and have felt terrrible due to the continual drop in stock price and reading about executives of the company continually selling shares. I have held due to the trust I have in you. I was very worried though that I had been taken. Feel better after your post.

Anonymous said...

Looks like market is not impressed with nnvc news.

Anonymous said...

Still feel comfortable holding this stock?

Allan said...

Absolutely. Two years to go, that's when price really matters, not during the midst of tax loss selling.

Anonymous said...

Allan - wasn't this your "stock of the year" for 2011?

It's lost 60% of its value this year. Will the company still be around in two years? Very few of these "story" stocks (e.g. cure for AIDS, 200 mpg engines, etc.) survive that long.

Please pick a better stock for 2012. One that at least should break even?

Allan said...

Here is my pick for 2012:

http://allallan.blogspot.com/2011/12/laura-marling.html

Anonymous said...

11 months to go until we hit $100 per share, huh Allan?

Allan said...

Who's counting? Even so, by my count the target date still has 23 months to prove itself.

It's looking to me more like mid-2015 until human trials will usher in a new era in our treatment of flu. Yet if this year's flu season intensifies, 2014 may very well be the bullseye.

Anonymous said...

Allan, you could be on track for 2014.