It is expected that the first cohort of the Single Ascending Dose study will be dosed in September, which given today's date should be fairly soon. It's a milestone... the clinical study will be confirmed as an action in progress when this announcement formally comes through.
ADOA will be our 2nd product to enter human trials, and there is a pipeline with more disease indications to follow that we know about and probably even more that we don't know about. Very importantly ADOA has been recognized by the FDA as a Rare Pediatric Disease and we have been granted eligibility to apply and possibly receive a highly valued Priority Review Voucher. A very positive and encouraging position for ADOA, indeed PYC and shareholders alike should be most pleased.
On the back of that we should get an update in the coming quarter for RP11 covering safety and efficacy data generated from the Multiple Ascending Dose study underway. If that data reflects earlier safety and efficacy signals then PYC will be in a very good position to possibly reach an agreement with FDA covering endpoints that may enable a significantly shortened registrational trial. We will also need to back that up with more data in Q12025, however the data coming through shortly (Q4 2024), will most likely serve as a good indicator of our path ahead.
Exciting times!
PYC Price at posting:
14.5¢ Sentiment: Hold Disclosure: Held
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