It's a diagnostic trial. Its objectives were to (a) investigate safety and tolerability of the product and (b) assess its ability to correctly detect recurrence of prostate cancer.
It completed recruitment in November 2024. As its a diagnostic trial and not a therapy trial, why would it take 18 months to report results? Shouldn't it be possible to report of safety, tolerability and ability to detect pretty much immediately? This was certainly Wilson's expectation when it reported in February 2024 that it expected results in H1-2024. So why the delay? And more to the point, why the lack of explanation from Clarity?
From first recruit to final recruit in SABRE took 14 months. 10 months for the first 25 and just 4 months for the next. Surely if the pace of recruitment increased, doctors were not concerned about safety, tolerability or the likelihood of detection. Now already 15 months since the last patient was recruited and all we've had is blown out timelines and no explanation from Clarity.
Readout in Q1-2025 has been explicitly mentioned and reported by Clarity on multiple occasions. Then in its half-year report, it slyly slips in that SABRE readout is to be provided "in the coming months" - so no chance of Q1-2025. No definitive timeline. A 12-month delay (vs Wilson's expectation) just in reporting results which in turn lead to exponential delays in designing, starting and completing a Phase III trial. Which in turn leads to a massive increase in expenditure and a greater funding gap.
The delays, obfuscating and ever-widening funding gap make Clarity a shorters dream, and its proven as such.
CU6 Price at posting:
$2.16 Sentiment: Hold Disclosure: Held
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