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wrinklesobw

06/27/24 8:50 AM

#176041 RE: rogers711 #176039

Well you need to do your research, Human trials won’t be taking very long at all.
8-12 months timing will largely depend on how many patients the fda requires. Since this is a device the number of patients needed will be probably around 8-12 patients at most, then how quickly the Mayo Clinic can get the volunteers, luckily we are partnered with the Mayo Clinic which has 3 hospitals in different regions they can recruit from not including if the Mayo reaches out to the local hospitals as well.

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nathanial

06/27/24 9:08 AM

#176043 RE: rogers711 #176039

Word of warning to the flippers of IDE submission and news.

Flippers, be very careful on selling into the submission of IDE. Once it is submitted, it could be approved very fast, like in a few days. I would sure hate for you to sell it and two days later the FDA grants approval of the IDE. But then again, karma does come into play. There may never be a selloff that you are expecting. Just some food for thought.

The FDA does not have to wait the 30 days for approval.