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Friday, March 08, 2019 6:21:29 PM
Patient selection actually was not made more restrictive by choosing best candidates but rather made more inclusive to those with weaker immune function by broadened (lowered) absolute lymphocyte count requirements. What I do think is that they thought they had good reason to do this without affecting treatment arm outcomes. If purer clearer signaling occurred by using a commercially viable cell selection process then perhaps this was expected to be enough to overcome the ALC changes. If SOC/placebo patients were eventing sooner but not treatment arm patients, compared to prior SOC/placebo patients, that might warrant a blinded look and or an unblinded safety look. A safety look may have discovered an absolute risk to SOC/placebo patients vs treatment arm patients and brought an end to SOC/placebo enrollment. For whatever the reason, and you know what I think, SOC/placebo enrollment seems to have been brought to an end on purpose. Best wishes.
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