NanoViricides Inc. (NNVC)

[changes_iv]

The news embedded in the news...

WEST HAVEN, CONNECTICUT -- August 7th 2013 -- NanoViricides, Inc. (OTC BB: NNVC) (the "Company") announced today that DengueCide™, its drug candidate for the treatment of dengue and dengue hemorrhagic fever, has been officially designated as an orphan drug by the US FDA.

This orphan drug designation qualifies NanoViricides for certain tax credits and marketing incentives under the Orphan Drug Act. In addition, the Company will qualify for the waiver of certain FDA fees when it files the New Drug Application (NDA) for DengueCide with the FDA. Further, the Company will also be eligible for a “Priority Review Voucher” (PRV) from the US FDA when the Company files a NDA for DengueCide.

“Now we intend to accelerate our dengue drug development programs to take advantage of these benefits,” said Eugene Seymour, MD, MPH, CEO of the Company. DengueCide is in pre-clinical development at present. If the pre-clinical development is successful, the Company will need to file an “Investigational New Drug” (IND) application to the US FDA and perform human clinical trials. If the human clinical trials are successful, then the Company has to file a NDA to the FDA to obtain approval to market the drug. There is no guarantee that DengueCide will successfully result in an NDA or a marketable drug product.

If the Company receives a Priority Review Voucher, it can be applied to accelerate the review of another one of our own drugs or it can be sold to another pharmaceutical company for a consideration. Priority review means that the FDA aims to render a decision on the NDA in 6 months. In contrast, the FDA aims to complete a standard review in about 10 months, and it often takes even longer. The estimated economic value of a PRV depends upon the drug class, and could be as high as a few hundred million dollars, according to Duke economists (Ridley et al. 2006; Grabowski et al. 2009). (https://faculty.fuqua.duke.edu/~dbr1/voucher/).

The Company has already filed a letter of intent as required for filing of an orphan drug designation application for DengueCide with the European Medicines Agency (EMA). A committee has already been established by the EMA to perform the evaluation. The criteria employed for orphan drug designation at the EMA are somewhat different from those employed by the US FDA. The benefits of an EMA orphan drug designation are different from those of the US FDA orphan designation. There is no guarantee that the Company will receive an orphan designation for DengueCide under the EMA.

The Company engaged the consulting firm Coté Orphan Consulting (COC), headed by Dr. Tim Coté, to assist with our DengueCide orphan drug applications to both the US FDA and the EMA.
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The Company continues to advance its injectable and oral FluCide™ broad-spectrum anti-influenza drug candidates towards clinical trials. Both of these drug candidates have shown extremely high effectiveness and substantial superiority to Tamiflu®, the standard of care, in the unrelated influenza virus types H1N1 and H3N2 in a high lethality animal model. ~ nanoviricides.com

http://www.nanoviricides.com/press%20releases/NanoViricides%20Announces%20that%20DengueCide%E2%84%A2%20Has%20Received%20Orphan%20Drug%20Designation%20From%20the%20US%20FDA.html

From the Bench to the Field and Back: A Global Approach to Dengue and Influenza

Today's news indicate to me that NanoViricides, Inc. is gearing up to produce batches (likely reproducible) of the new latest and greatest (optimized) DengueCide candidate for the coming clinical trials.

In order to move forward with DengueCide (contract signed w/Dr. Eva Harris' Laboratory) production I have the reasonable suspicion that Nanoviricides, Inc. must be done or nearly done producing batches (reproducible) of the FluCide candidate for clinical trials. That means we should be definitely close to more news for FluCide indicating that the BASi GLP Toxicology and Safety Studies have begun, IMO.

It don't come easy but we are getting closer to clinical trials!

After FluCide is given green light to market, it all becomes easy (or easier)!