Thursday, October 27, 2022 12:37:27 PM
You mean the post hoc data dredged recurrent GBM that was never part of the trial to begin with? The one that took massively increasing the external comparator to make the p-values work?? Or tossing out the PFS primary endpoint that she and the clinical team claimed they had methods to identify pseudo-progression. From her 2018 journal publication:
"PFS ...will be the subject of later analyses to allow for central, multi-factorial assessment by an expert panel, using criteria currently emerging as appropriate for immune therapy in this patient population where progression can be complex to determine and pseudo-progression is a known confounding phenomenon."
She was claiming that the clinical team had the method to read pseudo-progression. Guess when they did it, PFS failed to meet the endpoint so they tossed it out claiming confounding and replacing it with the confounded naïve OS endpoint.
"PFS ...will be the subject of later analyses to allow for central, multi-factorial assessment by an expert panel, using criteria currently emerging as appropriate for immune therapy in this patient population where progression can be complex to determine and pseudo-progression is a known confounding phenomenon."
She was claiming that the clinical team had the method to read pseudo-progression. Guess when they did it, PFS failed to meet the endpoint so they tossed it out claiming confounding and replacing it with the confounded naïve OS endpoint.
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