Saturday, January 30, 2010 11:52:25 AM
When testing for toxicity blood & urine is used which contain the drug being tested during in vivo preclinical, toxicity studies. However, several innovative in vitro toxicity test procedures are available utilizing non-animal human cell lines and certain chemicals, one is the MEIC Battery process which has proven to be the most effective predictor of human acute toxicity thus eliminating the use of animals & potential animal suffering. As well, these new in vitro toxicity study methods reduce the amount of time, but I understand can be more expensive.
http://www.pcrm.org/resch/PDFs/ae_invitro.pdf
However, NNVC has tested their drugs in over 2000 animals with no toxicity evidenced and all drugs have shown to be biodegradable excreted via normal bowel movements. I wonder if it is possible for NNVC to obtain some kind of waiver of sorts (if such is available from the FDA) regarding the necessity of thorough toxicity studies. I don’t know, but perhaps Dr. Feelgood or someone else may know that answer. I doubt the potential and whether it’s ever been applied for or allowed, but it makes sense.....but then again, common sense & the FDA make for strange bedfellows.
http://www.pcrm.org/resch/PDFs/ae_invitro.pdf
However, NNVC has tested their drugs in over 2000 animals with no toxicity evidenced and all drugs have shown to be biodegradable excreted via normal bowel movements. I wonder if it is possible for NNVC to obtain some kind of waiver of sorts (if such is available from the FDA) regarding the necessity of thorough toxicity studies. I don’t know, but perhaps Dr. Feelgood or someone else may know that answer. I doubt the potential and whether it’s ever been applied for or allowed, but it makes sense.....but then again, common sense & the FDA make for strange bedfellows.
Recent NNVC News
- Measles Rare Pediatric Disease Drug Designation Application Filed for NV-387, PRV Provides for Strong Business Case, Says NanoViricides • ACCESS Newswire • 04/07/2026 12:30:00 PM
- Phase II Clinical Trial of Monkeypox Treatment by NV-387 to Commence Soon, Announces NanoViricides • ACCESS Newswire • 04/01/2026 12:30:00 PM
- NanoViricides Presenting at NIBA's 152nd Investment Conference in Fort Lauderdale, FL March 12, 2026 - Announces Manufacture of Phase II Clinical Product NV-387 Oral Gummies is Complete • ACCESS Newswire • 03/11/2026 12:30:00 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 02/17/2026 09:30:47 PM
- MPox Orphan Drug Designation Application Filed for NV-387, Declares NanoViricides • ACCESS Newswire • 02/12/2026 01:30:00 PM
- Measles Orphan Drug Designation Application Filed for NV-387, Declares NanoViricides • ACCESS Newswire • 02/10/2026 01:30:00 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 12/30/2025 09:30:18 PM
- Form DEL AM - Delaying amendment • Edgar (US Regulatory) • 12/16/2025 09:30:05 PM
- Form S-3 - Registration statement under Securities Act of 1933 • Edgar (US Regulatory) • 12/15/2025 09:26:07 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/26/2025 09:30:33 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/14/2025 09:32:10 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 11/12/2025 07:54:28 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 11/12/2025 04:29:54 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/01/2025 09:07:54 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 09/29/2025 08:33:17 PM
