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Wednesday, November 02, 2022 1:12:48 PM
- RDGL submitted draft IDE
- At meeting FDA requested an additional meeting to discuss containment and dosimetry
- RDGL most likely submitted all data available, maybe even from the Batelle days which may have taken some time to dig out (I have been involved in similar cases where we tried to make our point to the FDA by sending all we had).
- FDA did not considered the data to be good enough (not necessarily for the reason you keep bringing up ad nauseum) and requested more controlled data.
- RDGL worked out protocol with JHU
- RDGL submitted protocol and requested meeting
- FDA approved protocol
So where is the lack of focus? Some of the activities take time and Vivos is not Merck or Pfizer with nearly unlimited resources and personnel. Could they go faster? Probably. But I don't see a lack of focus.
Recent RDGL News
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/13/2024 05:58:27 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/13/2024 05:56:22 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/07/2024 05:26:33 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/02/2024 01:00:03 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/29/2024 05:16:12 PM
- Form QUALIF - Notice of Qualification [Regulation A] • Edgar (US Regulatory) • 07/17/2024 04:15:04 AM
- Form 1-A/A - Offering Statement [Regulation A]: [Amend] • Edgar (US Regulatory) • 07/15/2024 10:02:55 AM
- 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 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
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