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Re: dr_lowenstein post# 534623

Thursday, 11/17/2022 10:03:23 PM

Thursday, November 17, 2022 10:03:23 PM

Post# of 701121

werent we told this was required by the FDA?



More recently that was the supposition but early on when I began investing we were told that without a crossover option it would be hard to recruit sufficient patients and that having the option to at least belatedly get DCVax-L after recurrence if one were in the placebo group was an important inducement not to mention the humane thing to do.

I would not be surprised if a regulator required it but Dr. Liau danced around that point to avoid appearing to blame regulators for issues like confounding.

So both things could be true in that a crossover was necessary to get enough patients and regulators, due to patient interests wanted it to go that way as well.
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