"... With the mgmt putting CLARIFY results on hold (?) until they conduct phase 3 in AMPLIFY ..."
The results are not present so - not on hold. I assume you refer to a future where CLARIFY completes ahead of AMPLIFY. Here are a some thoughts!
AMPLIFY looks like it will be designed for speed!
The pool that AMPLIFY will fish from (BCR) is about 4X the size of the pre-prostatectomy (the CLARIFY) pool!
The AMPLIFY sample size is smaller at 220 vs 383! That's 57% the size of Clarify!
There is a possibility of compressed trial timelines for AMPLIFY! That s because CLARIFY has some steps that will not be in AMPLIFY: Surgery planning (which could include Tumour Board meetings and pre-Anaesthetic assessments), the surgery itself (rather, the waiting for surgery), and then the tissue that gets sent to histopathology for analysis: stains, immunology, etc! We won't know for sure until we get to see the trial plan.
B) FDA Fast Track Designation will help!
Both trials are on FDA Fast Track, which supports rolling submissions of data.
Is it possible that CLARIFY is already submitting partial data? Why not?
What if the data shows overwhelming benefit!
C) ONE LAUNCH versus TWO?
Remembering: 64Cu-Sar-bisPSMA is one drug, with 2 indications (per the trials)! What are the potential gains and/or losses from having a single versus staggered launches?
Would it still matter if the timelines put the potential approvals close - such as at 6 to 12 months apart?
Does it matter that the BCR market (under the yet to start AMPLIFY) is the much larger market than the pre prostatectomy market?
CU6 Price at posting:
$2.08 Sentiment: Buy Disclosure: Held
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