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Thursday, March 13, 2014 12:44:52 PM
The balance is speed vs. going through all the paces the FDA and other WW reg bodies require.
I know of instances where specs were held more tightly than needed for safety and efficacy and that leading to poor process capability and consistency and repeatability in processing batches.
But CDER in FDA seems to be on the warpath of "consistency" and can greatly slow or stop you in your tracks if you don't meet their expectations - sometimes arbitrary and unrealistic expectations without consideration for practical, common sense balance of good enough for safety and efficacy vs. their (CDER) idea of perfect from a consistency standpoint.
So they are walking a fine line here. It appears that they feel they need to wait for scale up to make the Tox batches and processing more consistent with the planned further scaled up processing of batches they will make for clinical and commercial use.
There are a lot of judgement calls here and NNVC seems to be operating very conservatively. I hope not too conservatively.
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
VAYK Exited Caribbean Investments for $320,000 Profit • VAYK • Jun 27, 2024 9:00 AM
North Bay Resources Announces Successful Flotation Cell Test at Bishop Gold Mill, Inyo County, California • NBRI • Jun 27, 2024 9:00 AM
Branded Legacy, Inc. and Hemp Emu Announce Strategic Partnership to Enhance CBD Product Manufacturing • BLEG • Jun 27, 2024 8:30 AM
POET Wins "Best Optical AI Solution" in 2024 AI Breakthrough Awards Program • POET • Jun 26, 2024 10:09 AM
HealthLynked Promotes Bill Crupi to Chief Operating Officer • HLYK • Jun 26, 2024 8:00 AM
Bantec's Howco Short Term Department of Defense Contract Wins Will Exceed $1,100,000 for the current Quarter • BANT • Jun 25, 2024 10:00 AM