PYC will measure visual function and functional vision in these patients, (Cohort #4), using multiple ocular measurements, in addition to microperimetry. (Source, ASX announcement 6th May ’24). So, PYC are adding procedures for evaluating Cohort #4, this I believe aims to provide increased evidence to better support early efficacy signal readouts and the conviction that we are on a successful path with RP11.
Bear in mind… PYC commentary had confirmed previously that we are already in the ‘transaction window’. (Source ASX announcement 9th May, ’24) “PYC has entered the transactional window – creating optionality with respect to access to capital”.
No emergent serious adverse events for Cohort #4, and neither were there any emergent adverse events either, (Source, ASX announcement 1st July ’24). That is great news, in terms of safety profile for PYC’s proposed treatment for RP11. If there was a gold standard to define a safety profile, (at this stage of proceedings), surely our results would tick that box?
Big pharma have clearly demonstrated in recent times, a healthy appetite to do early deals rather than wait for the final registrational approvals from FDA, because getting in earlier increases their upside. If an interested party chooses to wait; it will cost them more to consummate a deal at a later stage.
So, the important questions for now are…
1) Is it safe?
2) How robust are the early efficacy signals?
We are looking as solid as can be with respect to our safety profile thus far and soon we may learn more about Cohort #4’s impact on early efficacy insights, which could exponentially build upon the positive early signal provided in Cohort #3.
Might be a very interesting time ahead soon for PYC? This Wednesday will mark 10 weeks since the completion of dosing for Cohort #4 for RP11. An inflection point maybe near?
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Ann: Commencement of RP11 Multiple Dose Trial, page-47
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