reply to
@cpt_yossarianDISCO closed recruitment early in December 2023. At the time, Clarity claimed:
"The sample size was adjusted to 45 patients based on the pre-planned assessment of the images to generate sufficient evidence to plan for a Phase III trial in this indication, enabling recruitment to successfully close early"The last patient follow up was completed in November 2024 - almost 12 months after the trial stopped recruiting.
In February 2025, Clarity announced that results of this Phase 2 trial would be reported "in the coming months".
Few questions:
1. Given that DISCO is an imaging trial, does anyone know what is being followed up almost a year after the patients are imaged?
2. Why would it take so long (looking like 6-ish months) just to collate the results of 45 patients?
3. If Clarity had enough evidence in December 2023 to plan for a Phase 3 trial, why would it take a further 18-ish months to not even have trial results, let alone a submitted Phase 3 application to the FDA?
4. On one hand Alan indicates (Franzis interview) that its possible that AMPLIFY and CLARIFY will complete recruitment in 2025 and have products commercialised by "2027 / 2028". On the other, he indicates that DISCO-PHASE-3 could result in Clarity's first commercialised product. If DISCO Phase 2 has taken two years, how would it be possible to design a Phase 3 trial, have it approved by the FDA, run a Phase 3 trial, follow-up patients, collate and submit results etc ... in less than 3 years?
(It is noted however that none of the commercialisation timeline pontifications actually make their way into formal announcements).
(20min delay)