PYC pyc therapeutics limited

FHC,I tend to think we will potentially learn of early signs of...

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    FHC,

    I tend to think we will potentially learn of early signs of efficacy from cohort #4 (SAD), once all patients have met the timeline and safety profile endpoints followed by the Safety Review Committee having verified the safety data in a duly scheduled meeting... followed by their report soon after.

    Early efficacy data is no doubt highly welcome, however at this stage of proceedings, safety is the key focus and I don't believe they will let us know until we have checked that metric appropriately.

    I remain quite optimistic that we will meet the safety endpoints, as non human trials that preceded the commencement of the SAD study demonstrated we could likely dose a human eye safely with up to 100mg. So to me, SAD cohort #4's, (75mg dose), is well supported by earlier data.

    Not withstanding the above, SAD cohort #4 dose size is 2.5 times greater than cohort #3, chances are we may get an even better efficacy insight and that would definitely provide great conviction that we will ultimately succeed in the final registrational trial for FDA approval.

    So yes, I think there are indeed excellent prospects that patients will be reporting early visual improvements, however we will most likely know once RP11 safety profile is confirmed rock solid.
    Last edited by Boomer55: 02/06/24
 
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