Thursday, August 08, 2024 1:11:35 PM
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174885057
JULY 29th
Based on our current discussions with the FDA, this week we should receive follow-up questions to fully analyze the risk/benefit device assessment of Radiogel®. We are confident that thus far our submissions have provided 90-95% percent of the information they require and that Vivos will be able to resubmit the refined IDE application with high quality responses demonstrating a compelling risk/benefit analysis to the FDA within the next 45 days.
We have been in regular contact with our collaboration partners at the Mayo Clinic and are well positioned to promptly submit, following receipt of the IDE from the FDA, our treatment plan to Mayo Clinic’s Independent Review Board (IRB). As previously discussed, the initial treatment target with Mayo for Radiogel® will be treating solid metastatic tumors in lymph nodes associated with papillary thyroid cancer. We remain dedicated to achieving full compliance and are confident that we will demonstrate a compelling risk/benefit profile to the FDA.
Never buy a stock based on my opinion of that stock.Form your own opinion by doing your own DD.My position on any stock I buy can change without notice.I am not a licensed broker or stock adviser and I really don't know what I'm doing.
Recent RDGL News
- Form QUALIF - Notice of Qualification [Regulation A] • Edgar (US Regulatory) • 03/06/2026 05:15:04 AM
- Form 1-A/A - Offering Statement [Regulation A]: [Amend] • Edgar (US Regulatory) • 03/04/2026 04:48:52 PM
- Vivos Inc. Diversifies Manufacturing Base with Planned U.S. and International Production Sites • GlobeNewswire Inc. • 02/17/2026 01:30:00 PM
- Vivos Inc. Announces Significant Progress Toward FDA Investigational Device Exemption (IDE) Submission for RadioGel® Precision Radionuclide Therapy™ • GlobeNewswire Inc. • 02/10/2026 01:30:00 PM
- Vivos Inc Updates Human Therapy Progress in India • GlobeNewswire Inc. • 02/03/2026 01:30:00 PM
- Vivos Inc. Strengthens Patent Protection with New U.S. Patent Issuance and PRECISIONGEL™ Trademark Approvals • GlobeNewswire Inc. • 01/28/2026 01:30:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/02/2026 04:06:21 PM
- Vivos Inc Summarizes Progress in its Animal Therapy Division • GlobeNewswire Inc. • 12/22/2025 05:56:08 PM
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- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/09/2025 09:00:31 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 11/21/2025 12:34:42 AM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/12/2025 11:08:03 AM
- Vivos Inc. Issues Shareholder Update Letter • GlobeNewswire Inc. • 11/06/2025 01:30:00 PM
- Vivos Inc. Strengthens Strategic Collaboration with Exubrion Therapeutics • GlobeNewswire Inc. • 10/29/2025 12:30:00 PM
- Vivos Inc. Retains Top FDA Regulatory Expert Dr. John J. Smith, M.D., J.D., to Support IDE Submission for RadioGel® • GlobeNewswire Inc. • 10/27/2025 12:30:00 PM
- Vivos Inc Board Authorizes Vivos Inc to Establish a Corporate Entity in India • GlobeNewswire Inc. • 09/29/2025 05:46:00 PM
- Vivos Inc Board Authorizes Vivios Inc to Establish a Corporate Entity in India • GlobeNewswire Inc. • 09/29/2025 12:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 09/18/2025 08:01:35 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/13/2025 07:32:46 PM
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- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 03/24/2025 04:47:18 PM
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