Yes, I believe we are at the "STOP MAX" spot after the decision rule for stage 1. ---------------- I also received word back from James confirming that: 1. The paxalisib arm will not enter stage 2 even at a later date. 2. Depending upon the eventual data from stage 1, there is still the possibility of FDA approval. ---‐------------ Of course, the data must always be "good enough" for FDA approval to occur. Entering stage 2 would seem to hint that FDA approval would be more likely, but personally, I never expected confirmation at this early point in the trial given what we already know from the previous phase 2 trial. In order to "graduate" to stage 2, a drug may very well have to double the OS to make its effect obvious so early on.
KZA Price at posting:
24.0¢ Sentiment: Hold Disclosure: Held