Updated Presentation Interesting slide (page 17) gives details around the proposed Phase II/III mBC trial.
ONCY has stated that trial will begin Q2 2025, and from the slide they would be able to apply for Accelerated Approval with 109 patient's worth of data. the slide suggests that this data would be available after 18 months. Failing the desired outcome, the trial would ensue to measuring OS.(123 events).
So... Inflection Points to come...
1) Partner to pay for this trial..? ONCY needs not just operating capital (it'll need a year's worth soon + money for the trial if going it alone). So partner = salvation, no partner = massive dilution, and ongoing dilution until 2028.
2) First patient treated (I wonder if this will still trigger milestone payments from Adlai Nortye?)
3) Data allows for submission of AA
4) Approval
Best one can hope for is accelerated approval by Q1/Q2 2028. Only 25 years after Brad Thomson's prediction of 2003... cool