Dave said that the FDA would never drop a control arm "because patients can get a transplant or VAD."
So its not just deaths but equivalent deaths as well i.e.. VADs and transplants in trial.
Should the patients have the option of a C-Pulse since very few would get a transplant and VAD's??.
Dave didn't answer some quite reasonable questions I sent about C-Pulse 2.
Maybe the control arm has minimal deaths/transplants /VAD's but given the Class 3 market is in the millions and the Class 4 market is in the 100's of thousands, its highly likely people are bombing out big time in the control arm.
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