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Wednesday, February 14, 2024 5:58:53 PM
The reason FDA suggested genotoxicity testing for Radiogel and didn't for other brachytherapies is obvious: Radiogel is targeting early cancers when a patient has much more to lose vs. brachytherapies targeting late stage cancers to extend life somewhat when the patient has almost nothing to lose. Since FDA flagged the genotoxicity omission upon reviewing MK's years late response to comments from first meeting in Nov. 2021, in all likelihood, FDA asked about genotoxicity in comments before 1st meeting and was dissatisfied with MK's years late response.
Recent RDGL News
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/04/2024 06:28:50 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/09/2024 09:30:31 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/27/2023 09:40:48 PM
- Form QUALIF - Notice of Qualification [Regulation A] • Edgar (US Regulatory) • 12/07/2023 05:15:10 AM
- Form 1-A POS - • Edgar (US Regulatory) • 11/27/2023 10:29:12 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/06/2023 04:28:46 PM
- Form 1-A POS - • Edgar (US Regulatory) • 11/03/2023 09:03:20 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/19/2023 04:18:34 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/11/2023 10:33:58 AM
- Form 1-A POS - • Edgar (US Regulatory) • 10/10/2023 04:05:36 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/04/2023 07:22:21 PM
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