CU6 clarity pharmaceuticals ltd

Hi Davisite, What makes you say this?This quarterly is opaque in...

  1. 1,280 Posts.
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    Hi Davisite,

    What makes you say this?

    This quarterly is opaque in terms of progress - so how can you tell how much is going on?

    For example:

    1. It sounds like none of the first 3 patients in Cohort 4 of SECURE have had a 3rd dose, even though this was supposed to happen in November.

    2. I can't make any sense of this statement regarding the second 3 patients in Cohort 4 "Recruitment of the additional three participants into cohort 4of the dose escalation phase of the SECuRE trial is nowcomplete, and the participants are currently in the safety andefficacy follow-up period with final participant completing finaldose as planned." What does this mean? They've each had one dose? Two doses? Why is this being referred to the "final dose as planned"? Aren't they each supposed to have 4 doses?

    Here was the timetable laid out by Bell Potter in November 2024:

    · - the first 3 patientsin Cohort 4 will receive their 3rd dose of 12GBq in November (this still hasn't happended)

    · - the second 3patients in Cohort 4 will receive their 1st dose of 12GBq inNovember (don't think this happened)

    · - the first 3 patientsin Cohort 4 will receive their 4th dose of 12GBq in February-25 (no chance of this happening)

    · - the second 3patients in cohort 4 will receive their 2nd dose of 12GBq inFebruary-25 (confusing bit. Can't imagine that the company will progresses this faster than BP's guesstimate, yet the company claims that "the participants are currently in the safety andefficacy follow-up period with final participant completing finaldose as planned")

    · - the expansion cohortwill commence dosing after the next safety Review Committee meeting inlate-Feb. (maybe. Company saying "this quarter")

    · - Final data fromcohort 4 is not expected until Q3-2025

    · - Final data from theSECURE trial in H2-2025

    3. No date provided for start of AMPLIFY

    4. No update on patient numbers (apart from first 2) in Co-PSMA Trial

    5. DISCO - no update.

    6. CLARIFY - no update on recruited patient numbers.

    29 pages of reporting makes it sound like a lot is going on, but almost all of it had been previously reported (eg a full page on DISCO which completed recruitment in late 2023, but has still not published results).

    Also getting concerned about leaks in the CU6 ship. It used to be that the SP reacted to announcements, now the announcements react to the SP. It ran up prior to the FDA Fast Track Designation and in ran down prior to the progress-light quarterly ...

 
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