The title is good, but the content confusing .... maybe because the trial results are confusing?
It sounds like since CU6 was unable to biopsy all the lesions for ethical reasons, the lesions picked up by it but (a) not picked up by the SOC and (b) not picked up by biopsy have to be considered "false positives". This has a significant negative impact on assessing the effectiveness of Cu64 vs SOC.
I had been confused by Alan's comment "We adhere to the highest standardsand methods of clinical development as we pride ourselves on high quality science at Clarity. As such, the COBRA trialdesign was built to reflect the gold standard in clinical research and took a very conservative approach." Now it makes sense.
Is this all irrelevant? Boiled down, the outcome of the COBRA trial is that it justifies a registrational trial. And obviously the design of that trial will account for the sensitivity of Cu64. But Wilson's seems to be implying that the inclusion of false positives may negatively impact Clarity's opportunity to get FDA accelerated approval and may also require a longer Phase III trial?
Anyone else read it that way?
If the lesions not picked up by the SOC but picked up by CU6 are then confirmed through biopsy, you'd have to assume the one's not biopsied are also there. If I'm a doctor or patient I want them found and treated regardless of a trial design designating them "false positives".
Seems really dumb unless I'm missing something ...
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