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Wednesday, March 06, 2024 12:54:31 PM
The consideration period for IDE application is 30 days. That's as expedited as it gets. BDD status, even if true, doesn't speed that. Burden remains with MK to deliver the IDE application. BDD status doesn't expedite that either, as FDA can't submit the application for RDGL.
So even if MK is lying about BDD status, it has no impact on speed of getting Radiogel to human trials. Sadly, MK has made very clear this is his lowest priority.
Recent RDGL News
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/04/2024 06:28:50 PM
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- 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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