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Re: exwannabe post# 249561

Thursday, 10/31/2019 7:22:57 AM

Thursday, October 31, 2019 7:22:57 AM

Post# of 689336

If ever a BLA is submitted, the FDA will compare to the control arm, as in all randomized trials. They will not compare to historical SOC.


Absolutely correct.

But investors can and should attempt to compare the results to SOC.

The problem is that most investors ignore the selection issues. All patients in the DCVax trial were non-progressing (as ascertained by MRI) prior to randomization. That results in a randomized population with superior survival characteristics than the entirety of the GBM population.

See here for a similar group (not identical, but similar).

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