Saturday, February 24, 2018 11:25:00 AM
I should have mentioned: It also doesn't make sense to have a pre-IND meeting with the FDA until some subset of the IND-required tox studies have been completed and those data are in hand.
NNVC has not said they've even started any such studies, let alone even identified a lead candidate to discuss at such meeting. They've also said in their recent 10-Q that their funds are insufficient for doing such work.
So it's possible NNVC has these pre-IND meetings with the FDA that are entirely useless because they go without any tox or CMC data (or even a lead candidate to discuss). That wouldn't be good, since it would destroy their credibility with the FDA.
Or it's possible they don't really have these pre-IND meetings with the FDA.
Given where NNVC is today, and the limited information they've made available to the investing public, there isn't a basis for coming to any regulatory, scientific, or technical conclusions regarding what NNVC has actually accomplished, or what problems they have that have prevented them from moving forward at 13 years and spending $80M.
A casual stroll through the lunatic asylum shows that faith does not prove anything. Friedrich Nietzsche
Recent NNVC News
- Form 8-K - Current report • Edgar (US Regulatory) • 08/09/2024 08:30:39 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 08/09/2024 08:05:25 PM
- 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
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