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SkyLimit2022

12/09/22 9:24 PM

#546770 RE: dr_lowenstein #546766

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
Bullish
Bullish