In about 3 weeks time PYC will possibly have 6 months worth of trial data for RP11 covering 8 x patients whom will have each received dosing equal to or greater than 30mcg. This compares to only 2 x patients tested for 6 months data, as reported 22nd November, 2024.
As these 6 month patient numbers increase, and the volume of efficacy data grows with that, we may see strengthening conviction that PYC is remaining true to its robust pathway. Methinks, based on reports thus far, (which have been outstanding), an opinion such as this has a decent basis for optimism however I am also mindful that nothing is set in concrete until it is. DYODD
Separate to the above, PYC shared a data pack relating to Polycystic Kidney Disease, (PKD), via an ASX announcement on 27th November '24, I noted from that announcement, PYC intended to formally file an application, before the end of December '24, with the FDA for approval to commence in-human trials. As of today, we haven't seen an announcement from PYC confirming their action of making that application, however I am not sweating that detail, more to the point I am super keen to know when the FDA does indeed provide PYC an official nod to proceed. I don't know how long it will take for the FDA to make such a decision, but surely if the application is thorough and complete it shouldn't take too much time.
Best wishes to all for 2025
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- Ann: Presentation of RP11 Clinical Trial Data at APVRS 2024
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Ann: Presentation of RP11 Clinical Trial Data at APVRS 2024, page-8
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