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flipper44

09/22/15 9:16 AM

#41315 RE: Doktornolittle #41312

In the main trial (possibly) 300 surrogate enrollment and 348 final/confirmitory enrollment, there are not supposed to be any pseudo progressives -- at least not those detectable at the beginning of the trial.

Inside the phase III trial, there are an additional group of 32 pseudoprogressives analyzed separately, but still in a placebo controlled design.

In the 51 info arm, outside the main trial, there is one confirmed pseudo progressive.

In the 99 expanded access arm, there are likely many pseudoprogressives in an unblinded setting.