Wednesday, June 28, 2017 8:01:29 PM
In NNVC's case, that means CMC work would have to be done for the general polymer backbone (which I assume you mean by "micelle") with the specific ligand attached.
The fact that each half of this combination can be manufactured and studied separately doesn't negate the requirement that all the CMC work also has to be done for the exact molecular structure to be used in humans.
The fact that the same micelle can be used with different ligands doesn't negate this requirement. It's the combination that is seeking approval, not the micelle without the ligand. Hence the FDA will only be concerned about the CMC work for the micelle+ligand, and not just one or the other.
The same would be true for any regulatory agency in any country.
A casual stroll through the lunatic asylum shows that faith does not prove anything. Friedrich Nietzsche
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
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NanoViricides Reports that the Phase I NV-387 Clinical Trial is Completed Successfully and Data Lock is Expected Soon • NNVC • May 2, 2024 10:07 AM
ILUS Files Form 10-K and Provides Shareholder Update • ILUS • May 2, 2024 8:52 AM
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