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Re: HyGro post# 512969

Friday, 09/23/2022 12:15:44 AM

Friday, September 23, 2022 12:15:44 AM

Post# of 822795
No, they submitted it before they unblinded HyGro, saying otherwise, over and over again, does not change the facts. The SAP was submitted pre-data lock. And the reality is, for the same reason they understood that they had lost most of their placebo patients because they had almost all crossed over, they also knew that 1) they needed an external control arm, which they applied for and got from all the regulators pursuant to reforms at all of the regulators on the subject; and 2) they knew that while the placebo arm could not be used to show new Glioblastoma data because they had crossed over and the measure now was survival, those patients could now be used to show survival FROM recurrence and cross-over. Pretty elementary.

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