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Re: dr_lowenstein post# 546766

Friday, 12/09/2022 9:24:21 PM

Friday, December 09, 2022 9:24:21 PM

Post# of 692869
Thanks for asking.

There have been approvals based on ECAs, but those approvals are really irrelevant to murcidencel because murcidencel has been studied in three trials and only one of those three relied on an ECA. Furthermore, GBM and especially rGBM represent a major unmet need worldwide.



https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track



https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847
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