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familyof5

08/08/24 1:11 PM

#178459 RE: kayak_wench #178442

All you NEED to hear/know is it's happening. And most likely at an hour when you least expect it. Nothing like the element of surprise to swing the pendulum with supersonic speed FORWARD>>>>>don't be standing in the way when it happens.....tick tock
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.