"What worried me, however, was that PFS was a secondary endpoint, and people seemed to be ignoring the primary endpoint (decreased toxicity)."
The primary endpoint was not met because the HyACT technology gives decreased toxicity!
I'll explain. Meditech originally were going for "decreased toxicity" as an approvable reason for HyACT. In meetings with the FDA it was suggested that the decreased toxicity could mean that more chemo drug could be administered, to a similar point of acceptable toxicity.
Hence decreased toxicity could have been achieved but was sacrificed for increased dosage.
So really the primary endpoint was achieved, if like for like had of been used in the control arm.
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