Monday, September 15, 2014 12:54:58 AM
The second reference is mistaken reporting on the part of Forbes. The Animal Rule guidance is clear and I quoted it in a previous post (see quote below). Safety testing is still required.
But the Animal Rule must not have been followed. Mapp did not go through FDA. The Department of Defense must have overruled.
That puts more importance on the speculation of Partnerships with NNVC e.g. USAMRID.
Partnerships with agencies with research authority is the 2nd exception to following US law enforced by FDA (as I also pointed out in previous posts). This is what Mapp most likely did and provides a potential path for NNVC to abbreviated safety testing without full GLP Regulatory Tox.
I am a little surprised (and possibly wrong about all my safety posts) if Mapp did not have at least some GLP or extensive non-GLP animal safety data to provide assurance to DoD prior to use - even though it seems they did not start the full GLP Regulatory Tox testing.
This will be my last post before my work week starts - just a heads up I will not likely have time to post for a while.
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
- Clinical Trial of Broad-Spectrum Antiviral Drug NV-CoV-2 is Progressing Well, Says NanoViricides - NV-CoV-2 is Positioned to Fulfill Many Unmet Medical Needs • InvestorsHub NewsWire • 07/06/2023 03:16:37 PM
Avant Technologies Engages Wired4Tech to Evaluate the Performance of Next Generation AI Server Technology • AVAI • May 23, 2024 8:00 AM
Branded Legacy, Inc. Unveils Collaboration with Celebrity Tattoo Artist Kat Tat for New Tattoo Aftercare Product • BLEG • May 22, 2024 8:30 AM
"Defo's Morning Briefing" Set to Debut for "GreenliteTV" • GRNL • May 21, 2024 2:28 PM
North Bay Resources Announces 50/50 JV at Fran Gold Project, British Columbia; Initiates NI 43-101 Resources Estimate and Bulk Sample • NBRI • May 21, 2024 9:07 AM
Greenlite Ventures Inks Deal to Acquire No Limit Technology • GRNL • May 17, 2024 3:00 PM
Music Licensing, Inc. (OTC: SONG) Subsidiary Pro Music Rights Secures Final Judgment of $114,081.30 USD, Demonstrating Strength of Licensing Agreements • SONGD • May 17, 2024 11:00 AM