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Posted On: 07/17/2020 2:06:40 PM
Post# of 148899
Thanks for responding. So you believe there’s no way the FDA can make us go back and prove safety via a phase 1 trial after they let cydy skip it and approved phase 2/3? The author of the SA article stated in comments section that cydy would have to prove safety somehow that would be acceptable to them before a covid approval but didn’t say what that would be. He’s suggesting that the BLA safety info can’t be used. So can it be be used and if not how can safety be shown? To me this is a crucial question. I want to believe you are right but I don’t trust the FDA. Can you imagine getting great results only to be told we can’t prove safety because of that BLA status?
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