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CytoDyn Inc CYDY
(Total Views: 615)
Posted On: 05/08/2020 12:40:15 PM
Post# of 154120
Posted By: Flash08
Re: DJknows #32918
It is common knowledge that the FDA will have questions that come up after an initial BLA submission. Anyone who has worked to get technology approved knows this will occur. I cannot imagine there being very many submissions that do not require follow up responses. Coming from 40 years in the medical business I am surprised we got a response so quickly from the FDA. I consider this a good sign.

I just spoke to a friend of mine who worked hand and hand with the FDA on product extension approvals in the Cardiovascular market and he stated it would take them a year, in many cases, to get a product extension for diagnostic imaging software. There were many questions back and forth that the FDA requires to make sure there are no mistakes that can hurt a patient.

These lawyers are bottom feeders in my opinion, very similar to ambulance chasers, and they should be ignored.- IMO













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