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wrinklesobw

04/04/23 8:05 AM

#159591 RE: anderson800 #159589

Another thing to remember, once the ide is submitted the fda can approve it at anytime, it doesn’t necessarily have to go the full 30 days. With doing the EFS the fda already knows a lot about the product. So in my opinion we will here something fairly quickly after submitting.
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SC8

04/04/23 9:15 AM

#159597 RE: anderson800 #159589

Mayo docs will do anything RDGL pays them to do. My guess purpose of April exercise is to strengthen the IDE application by demonstrating Mayo docs are already well versed in Radiogel application and imaging and just need FDA green light to commence human trials.