Co-PSMA TRIAL(Adding to the above discussion)
a) I don't remember a June mention in the interviews and have not read that anywhere either. All I heard was "End of this year". But I did pick up suggestions of some fluidity at play - a lot of phrases like, "we could do a and b, and complete this, c by time t, and be in the market by z. I think there are lots of moving parts, and the company decides which is which, and when.
b) Co-PSMA not a pre-registatiinal trial so it's not part of what the FDA asked for. The FDA approved CLARIFY and AMPLIFY for that. But that doesn't stop Clarity from submitting data from Co-PSMA as well when they apply for approval.
c) The purpose of Co-PSMA (the head to head) is to demonstrate superiority, which is not required by the FDA, but is useful for market capture and pricing power.
d) Breakthrough status was emphasised in the Frazis interview. Clarity will apply for it (if both already done), and what that might mean with regards to strategy - no idea. But again, it's for Clarity management to decide and implement.
e) Can Co-PSMA replace or merge with AMPLIFY? Co-PSMA is a superiority seeking trial so it is already built to be scientifically robust, with a much more challenging bar than what the FDA requires (as in AMPLIFY). The patients are the same (BCR). But Co-PSMA is small (50 patients), so IMO, if the new FDA were to agree to a merging, it could simply be a case of increasing the sample size (more than 50 is likely required to power the trial sufficiently) and adding a US arm as a sort of bridge.
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In the END, we do not know what the target end goal is. Last year many were jumping in in anticipation and hope of a Buy Out. It hasn't happened, so changes are inevitable.
(20min delay)