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Post# of 822142
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exwannabe

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exwannabe

Re: dennisdave post# 774058

Thursday, 07/03/2025 2:39:54 PM

Thursday, July 03, 2025 2:39:54 PM

Post# of 822142

the reason why these idiots COULD NOT submit in the US is that the FDA does NOT offer guidelines for an ECA RWD (especially without IPD) based BLA.


See the FDA guidance on RWE/RWD
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