![](http://investorshub.advfn.com/images/default_ih_profile2_4848.jpg?cb=0)
Friday, October 11, 2013 1:23:35 PM
Now we are fully aware of the "low toxicity" of a nanoviricide...dang, there goes another uncertainty that the "others' negativity" liked to harp on but, no more.
Fast Track, Priority Review, Accelerated Approval: NNVC has a good shot at ALL of them:
No one (including myself) is "banking on it" or saying its a sure thing. But it is a very real and strong possibility: If the more accurate tests give the same results as the early crude tests on both toxicity and efficacy it would meet the criteria for an FDA fast track.
A fast track is not a slam dunk, but it clearly is a very real possibility.
THE KEY POINT is that the combination of very low toxicity and high efficacy for conditions for which the current therapy is of poor efficacy (or there just is none) would qualify a drug for all of the below. And IF the toxicity tests confirm the results of earlier tests, then NNVC's drug will qualify. (but accelerated approval isn't much use for a very short disease like influenzas).
NOTE THAT A COMPANY CAN REQUREST A FAST TRACK AT ANY TIME. NNVC might well do it after the toxicity tests if the data support it. ~ ZincFinger
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=92833532
Thanks to ZincFinger for spelling out the FAST TRACK.
NanoViricides says pre-IND meeting with FDA for FluCide "successful"
The company, with guidance from its regulatory consultants at the Biologics Consulting Group, Inc., had previously determined that filing a pre-IND was important at this stage in order to understand potential FDA-required studies prior to filing an IND.
"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."
source: http://www.proactiveinvestors.com/companies/news/27192/nanoviricides-says-pre-ind-meeting-with-fda-for-flucide-successful-27192.html
NanoViricides, Inc. is a "Thoroughbred" of a company in the making and we could use a Fast Track for it, away from the track for loaded mules.
Nanoviricides, Inc. will continue breaking new ground with their "transformational-technology" and we, as well as mankind, will benefit immensely from it.
"...you're about to see something, that you ain't never seen before"
"by the way, I'm sure that when you think 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" ~ Dr. Eugene Seymour, CEO Nanoviricides, Inc.
Recent NNVC News
- NanoViricides Reports that the Phase I NV-387 Clinical Trial is Completed Successfully and Data Lock is Expected Soon • InvestorsHub NewsWire • 05/02/2024 02:07:42 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/16/2024 09:53:32 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 02/14/2024 09:55:35 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/19/2024 09:44:48 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 12/04/2023 09:08:49 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 10/13/2023 08:30:41 PM
- Form NT 10-K - Notification of inability to timely file Form 10-K 405, 10-K, 10-KSB 405, 10-KSB, 10-KT, or 10-KT405 • Edgar (US Regulatory) • 09/28/2023 08:44:54 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 09/01/2023 08:46:45 PM
FEATURED ELEMENT79 GOLD CORP PROVIDES UPDATE ON CHACHAS COMMUNITY CHARTER AND REVENUE GENERATION, M&A ACTIVITIES • Jul 30, 2024 8:00 AM
FEATURED Cannabix Technologies to Deliver Innovative Breath Logix Alcohol Screening Device to Texas, USA • Jul 29, 2024 9:07 AM
Avant Technologies Opens Equity Line with GHS Investments as Company Explores Expansion into Additional Technologies • AVAI • Jul 30, 2024 8:00 AM
INDEXR AI Merges With Moon Equity Holdings Corp. (MONI), Creating a Leading-edge Technology Company • MONI • Jul 29, 2024 9:59 AM
BNCM AND DELEX UNVEIL POST-MERGER MANAGEMENT PLANS • BNCM • Jul 29, 2024 9:00 AM
Glidelogic Corp. Announces Revolutionary AI-Generated Content Copyright Protection Solution • GDLG • Jul 26, 2024 12:30 PM