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Friday, May 03, 2024 5:00:10 PM
I love their new tagline. It really fits the bill of how Radiogel/IsoPet works.
I recall they estimated the gentoxcity analysis was estimated to last 6 weeks in the Jan update. The date I saw them report the gentoxcity testing itself done was Apr 1 in the 2024 Q1 report. That would mean gentoxcity analysis should wrap up in mid-May.
They have not yet sent the rabbit testing (VX2) report to the independent review group. I would expect that would take at least 2 weeks to review with up to 2 weeks follow up (all that 6 weeks, 2 weeks to wrap up, 2 weeks for review, 2 weeks for back and forth). Putting that out to mid-Jun.
Hydrogel self-life is being finalized so that should get done in May.
So from my math it looks like mid-Jun is probably the most likely for IDE submisssion. With early or late June being when it actually occurs
The schedule has slipped because back in early Mar their estimates made it look like end of April. Not at all surprising and they should be taking extra care and not rushing. They may just consume most of Jun to allow themselves to be able to put the draft aside for a few days before re-re-reviewing it. When you spend so much time/energy on a document you need to distance your self from it on occasion to 'see' it clearly to get the best quality.
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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