The .12 cent threshold has been breached. You didn't have to wonder.....
But what do I know. I just showed up a month or two back RIGHT?..... by the way.....that so called stubborn break through of the .12 cent level will be surpassed here sooner rather than later....tick tock
I don't anticipate it taking the full 45 days to remedy. Nor do I see where it would be beneficial dragging the resubmission out if that extra time is not needed. Dr. Korenko did state on the 29th of July WITHIN 45 days. We're now 23 days in. I would think Dr.Korenko would PR the event at a time of his own choosing that would be most impactful and beneficial (AFTER MARKET CLOSE or PREMARKET OPEN) to those of whom have had the courage and loyalty to hold through the good and bad (Those impacted by the PREMARKET delay PR July 29th), the thick and thin. And at a time ye think not. This is not a view intended to create a sense of FOMO urgency or hysteria. But my own personal PERCEPTION of how things play out here. Remember, the current goal is to position, and to be in the position, to RESUBMIT the IDE application with the FDA's follow up request satisfied, and with the FDA's blessing. I have been RIGHT ON with my calls here more than RIGHT but a little OFF. I can say with a fair sense of confidence that I think this will be the case once again. But what do I know. I just showed up a month or two back RIGHT?..... by the way.....that so called stubborn break through of the .12 cent level will be surpassed here sooner rather than later....tick tock
JULY 29TH Press Release:
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.
AUGUST 16TH
Update from the CEO regarding the ongoing discussions with the FDA. General updates will be posted on this platform as new information becomes available. Subscribe to our newsletter at https://t.co/FfgSTxpyrZ for important press releases for #RadioGel and #IsoPet$RDGLpic.twitter.com/1t2fJ1hcnS