2) - the Safety Review Committee recommends higher doses / multiple doses of cu67 just weeks after patient dosing. Is "longish safety monitoring" really part of cu64 trials?Still struggling to understand why it takes such an extended time post final patient dosing to make an FDA submission for these diagnostic trials.
No idea why, but some things happened which could have called for a change of strategy!
1) The change to reimbursements in the US made diagnostics very attractive. His mention of the combined MC of TLX and Lantheus ($20billion, when all they sell are diagnostics - and the $3billion market for these diagnostics in 2 to 3 years), suggests to me that this situation may have caused some thinking! Not to mention, CB showing an interest!
2) Fast Track Designations were received, setting up an accelerated path to approval for both CLARIFY and AMPLIFY trials outcomes! His determination and confidence about Breakthrough designation was on show too! I do not think his timeline predictions (2027/28) take this into account. We will see.
4) The Head to Head was non existent this time last year! He values this very highly, as does Louise Emmet! He says that that trial is recruiting well, and, he is super confident that the results will be positive. That CB is turning to Clarity for a partnership is interesting and informative. Anyhow, AT believes that the FDA will notice once those results are out!
5) CLARIFY recruitment timelines are stretched, and reality seems to suggest they will merge with those for AMPLIFY (which hasn’t even started). We also know that, while CLARIFY needs histology (its inbuilt into the trial), AMPLIFY (which we expect to be an expanded COBRA trial) will not require it.
Under these new conditions, would it still be better to pursue the CLARIFY's pre-prostatectomy indication alone, or to go for both pre-prostatectomy (CLARIFY) and AMPLIFY's BCR? Afterall, the BCR market is FOUR times larger than the CLARIFY target market!
Which is better: marketing the product for one indication, then coming back months later with the same product, but for another indication, or doing it for one broad indication from the word go? Particularly in a situation where the SOC Ga68 and F18 products that need to be displaced, are already used in both of the indications?
I do not know why, but I can see why!
----
CU6 Price at posting:
$1.46 Sentiment: Buy Disclosure: Held
A personalised tool to help users track selected stocks. Delivering real-time notifications on price updates, announcements, and performance stats on each to help make informed investment decisions.
(20min delay)