NanoViricides Inc. (NNVC)

[KuChing]

So what are the steps to PRV, and how long will it take? Plausible case: NNVC Dengue-cide PRV application September 2010, approval March 2011.

1) NNVC has identified 1 of 16 neglected tropical diseases, Dengue Fever, and a significant protection for it, Dr Harris et al. (February 2010, June 2010).
a. http://www.news-medical.net/news/20100217/NanoViricides-signs-research-and-development-agreement-with-Dr-Eva-Harrise28099s-laboratory-at-UC-Berkeley.aspx
b. http://www.drugs.com/clinical_trials/anti-dengue-nanoviricides-achieve-significant-protection-initial-vivo-studies-dengue-hemorrhagic-9667.html
2) NNVC is isolating Dengue-cides to find the most effective formula against all 4 strains of Dengue per “Dr Feelgood ” et al, IHUB September 2010.
a. http://investorshub.advfn.com/boards/read_msg.aspx?message_id=55072359
b. This was stated in the June 2010 NNVC PR as well. This study could be complete.
3) It has also been mentioned on IHUB that it is a natural for Dr. Harris to administer the final Dengue-cide at her clinics in South America as part of her Sustainable Sciences Institute out reach.
a. If done correctly, results could be used for FDA PRV approval.
b. PRV Application to FDA costs $1.542 M for fiscal 2011. It is not clear what the fee/cost was for FY 2010. If it were zero, that may have been incentive enough for NNVC to file for PRV Dengue-cide before September 30th 2010. That may also be a contributing reason for the additional shelf offering with Seaside 88.
c. http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2010/09/put-it-on-mr-underhills-bill-fda-sets-priority-review-voucer-redemption-fee-at-almost-46-million.html
4) Assuming the PRV application has been submitted before September 30th 2010, March 2011 may be when NNVC receives approval.
a. It appears that Novartis submitted their PRV application for Coartem malaria drug to the FDA in October or November 2008 and received approval in April 2009.
b. http://www.pharmalot.com/2008/11/novartis-and-the-fda-priority-review-voucher/
c. http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2009/04/fda-approves-coartem-with-priority-review-voucher-voucher-market-is-untested-and-unclear.html
5) Tox studies are required before submitting the NDA for PRV
a. http://www.essortment.com/all/fdadrugapprova_rrgy.htm
b. Since the June 2010 NNVC PR already discloses the fact that further refinement of the Dengue-cide had started, it may be that tox studies have already been initiated.
c. As has been mentioned by “Dr Feelgood” on IHUB, the test cycle for antivirals can be weeks given the fact that viruses are short lived.
d. Bottom line March 2011 could be a big month for NNVC.