After thinking more about your question re the safety review committee, I went back through the announcements. it would appear that the announcement of the SRC findings are not long after they meet, that is unless of course i am interpreting it incorrectly. So based on your date of June 12th, next week could be a great week
This is the text from the Shareholder update on the 26th of April
Material progress was made in each of the Company’s three most advanced programs.
• Retinitis Pigmentosa type 11 (RP11) – PYC completed dosing in the third cohort
of patients enrolled in the ongoing Single Ascending Dose (SAD) study in Q1 2024.
The objective of this study is to establish a safe and well-tolerated dose of the drug
candidate to progress into a Multiple Ascending Dose (MAD) study.
The MAD study is scheduled to commence in Q2 subject to a successful review of
the safety and tolerability profile of PYC’s drug candidate in this patient cohort 3.
This review is scheduled to occur in April 2024. Successful completion of the SAD
and MAD studies will enable PYC to progress its drug candidate for RP11 into a
registrational trial directed towards a New Drug Application and successful launch
of the first therapy available for patients with this blinding eye disease.
This is the text from the 29th April
The Safety Review Committee (SRC) governing this clinical trial has met
to review the data for the 3 patient cohorts who have received PYC’s
drug candidate to date
• All 3 doses have been determined to be safe and well tolerated by the
SRC – opening up a pathway for PYC to:
o initiate a Multiple Ascending Dose (MAD) study now that the dose
at which RP11 patients are expected to derive a benefit from this
drug candidate has been reached; and
o continue to escalate dosing in the SAD to identify the dose at
which RP11 patients derive maximum benefit from the drug
candidate prior to initiation of a registrational trial1
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