Vivos Inc (RDGL)

[familyof5]

"Probably not the most likely but not zero either" You and ASCM seem to basing your skepticism, that the FDA will punt this go round, on the number of items (63) the FDA requested further clarity on. But more so because of this one paragraph from the Jun 28th press release announcing application submission.....I won't ridicule you for that. But I do take exception to your deceptive style of posting. Some of which we have witnessed again here today. I've said this before and I'll say it again. Very odd behavior for someone who claims to be long here....your living proof rock bottom still has a basement.....

Dr. Korenko stated, “We are mindful that most of the twelve FDA reviewers have joined in the past two years and we anticipate they will have some comments after reviewing the extensive material in our filing, which we are prepared to address promptly.”

Vivos Inc. Submits the Application to the FDA for Authority to Initiate Human Clinical Trials

Richland WA, June 28, 2024 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL), Vivos Inc. filed the application for an Investigational Device Exemption (“IDE”).

The filing was an amendment, addressing the FDA comments to our previous application (Q211938/S001). Today’s IDE submission marks our first filing with the FDA following the grant of the FDA Breakthrough Device Designation for the Radiogel™ Precision Radionuclide Therapy. We are appreciative of the improved communication with the FDA since receiving the breakthrough designation. Our IDE filing contained reports on two complex studies, RadioGel® genotoxicity and the retention of RadioGel® at the injection site in VX2 tumors in rabbits. This current IDE submission addressed the 63 FDA comments received in previous FDA correspondences. In some cases, we repeated underlying testing to strengthen our answers with current data. Dr. Korenko stated, “We are mindful that most of the twelve FDA reviewers have joined in the past two years and we anticipate they will have some comments after reviewing the extensive material in our filing, which we are prepared to address promptly.

In closing Dr. Korenko stated, “We are eager to secure the FDA’s IDE approval so that we can submit our plan to the Mayo Clinic's Independent Review Board (IRB) for clearance to initiate the first in human clinical trials. This is an exciting time for Vivos and we are committed to bringing a new treatment option to patients in the fight against challenging cancer types. Initially our collaboration with Mayo will be targeting solid metastatic tumors in lymph nodes associated with papillary thyroid cancer.

Dr. Michael Korenko
Vivos Inc.
Michael K. Korenko, Sc.D.
President & CEO
Email: [e-mail]

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