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Friday, December 21, 2018 11:04:58 PM
This is also why the bears said PFS failed and why there were no additional SOC/placebo patients allowed into the trial after the screening halt. PFS may have failed by the old standards but.. the process of adjudication of endpoints was conveniently written into the guidelines after immunotherapy was determined to have a different MO with regard to activity and benefit. Hey Linda, can you ask FDA if we are there yet? Patients deserve to get this treatment right now with at least an 80% reimbursement rate of potential final rate based on blinded data and regulator decisions not to allow any last patients in the trial have SOC/placebo. Best wishes.
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