Tuesday, December 12, 2023 6:42:18 AM
DewDiligence
Member Level
Re: stocksrising post# 250000
Saturday, 12/09/2023 5:38:10 PM
BLUE didn’t get a priority-review voucher for FDA approval of Lyfgenia because the FDA deemed that the “active ingredient” in Lyfgenia is the same as in BLUE’s Zynteglo, which was approved in 2022 for beta thalassemia (#msg-169711368).
This is a seemingly odd interpretation by the FDA of the term, “active ingredient,” but the FDA is given broad discretion by the legal system in these kinds of decisions
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