Replies to post #315 on Bluebird Bio Inc (BLUE)

[stocksrising]

Spot on Moose, no PRV because of same ‘active ingredient’…I received a message from a Highly Respected poster and he replied back to my same question:

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

[novicetrader]

Thanks, guess that's it then about the PRV. Disappointing for sure,but BLUE will do okay even without. Let's hope there will be breakthroughs on the Insurance cover or treatment pricing.