Friday, October 07, 2022 4:47:44 PM
foxhound02, let me get this straight. So you are saying the following:
(1) The DCVax-L Phase III trial was positive, and it did meet both its Primary and Secondary endpoints with statistical significance; and
(2) DCVax-L did prove that it is efficacious, and it did significantly extend Overall Survival (OS) for both newly diagnosed GBM (ndGBM) and recurrent GBM (rGBM) patients; and
(3) DCVax-L also proved that it was very safe, and it did not cause any, or very few, serious adverse events (SAEs);
"BUT, DCVax-L will not be approved by regulatory authorities, even though it is safe and it help ndGBM and rGBM patients live longer".
Is that really what you are saying?
(1) The DCVax-L Phase III trial was positive, and it did meet both its Primary and Secondary endpoints with statistical significance; and
(2) DCVax-L did prove that it is efficacious, and it did significantly extend Overall Survival (OS) for both newly diagnosed GBM (ndGBM) and recurrent GBM (rGBM) patients; and
(3) DCVax-L also proved that it was very safe, and it did not cause any, or very few, serious adverse events (SAEs);
"BUT, DCVax-L will not be approved by regulatory authorities, even though it is safe and it help ndGBM and rGBM patients live longer".
Is that really what you are saying?
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