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SkyLimit2022

12/10/22 12:14 AM

#546825 RE: dr_lowenstein #546822

It’s public information just as those other drug approvals are. The 45 are not oncology drugs and are therefore less relevant in my view.

Furthermore, RWE will not form the entire basis of any regulatory decisions with regard to murcidencel which has been studied in three trials—only one of those three relied on an ECA. All clinical data are relevant to a regulatory application including those data gather from other studies and compassionate use. All three trials have substantial safety and efficacy data available, and two of the three clinical trials ran for over a decade with survivors alive today.


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