Vivos Inc (RDGL): Yes you're right. New rules because the...

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Re: West Coast Snapper post# 51570

Wednesday, 12/16/2015 10:07:32 AM

Wednesday, December 16, 2015 10:07:32 AM

Yes you're right. New rules because they deemed radiogel not comparable to any prior device.

So yes the fda has officially considered it different than any prior product so more testing is needed.

Not that the testing is gauranteed for anything because the fda's confidence is very low for radiogel by reading the last denail.

FDA says flat out:

"We do not believe that the benefits of your device outweigh the risks. "

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Recent RDGL News

Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/13/2024 06:12:17 PM
Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/28/2024 08:23:49 PM
Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 09/30/2024 04:34:12 PM
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

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