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01/22/22 2:09 PM

#437763 RE: hope4patients #437758

So it would be 100% impossible to conduct an efficacy analysis in 2015.



Yes… it’s very evident that the 2020 SAP was the first and only SAP… perhaps LP thought they would begin to assemble one in 2015, but instead held back. I do believe that she’d said at one of the ASMs that they had done a blinded, what she called a “Spring Refresh”, and she stated(as I remember) that they began doing these in 2015.

They MAY have realized at that point that the blinded PFS numbers weren’t adding up at that time (2015) to bring about the result they were looking for (they’d boxed themselves in, at the time, to using only .02 alpha as a measure) to file for accelerated approval. Perhaps there were more PFS (likely false) events than there should be. So perhaps they instead chose to wait for the PFS data on the more recently enrolled patients to see if those BLINDED numbers would improve.

Just putting forth a plausible, but wholly made up, hypothetical.