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Re: HyGro post# 592335

Thursday, 05/11/2023 10:41:18 AM

Thursday, May 11, 2023 10:41:18 AM

Post# of 823592
HyGro,

Your ideas do not align with the facts.

Your ECA comments are irrelevant because you don’t have to consider the ECA trial if you don’t want to—there are other DCVax-L trials. Furthermore, just like other efficacious drugs such as pembrolizumab, DCVax-L will continually be studied in other cancers and other drug combos/other
PD1 combos even after commercialization. Keytruda was approved many years ago and has been a blockbuster, but it has continued to be studied in more clinical trials ever since.

There was only one ECA trial. That trial was clinically appropriate, adaptive, and compassionate.

Data collected from the P3 and ECA comparison only comprise a fraction of the clinical efficacy data that exist for DCVax-L today. DCVax-L (murcidencel) has been studied in three notable trials that have reached data collection points—only one of those three trials relied on an ECA, and the ECA included over a thousand well-matched contemporaneous patients.

Additionally, nGBM and rGBM especially are unmet medical needs having a clear and well-documented prognosis.

Furthermore, any and all lingering criticisms that naysayers may have will be dispelled during the confirmatory period following commercialization (this applies to all drugs). In the hands of practicing clinicians worldwide, we can learn more about this cell-based technology as a platform.

Skip to timestamp
8:01 when Dr. Liau again confirms that the crossover was mandated by the FDA.
https://edhub.ama-assn.org/jn-learning/audio-player/18738384


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