cheynew, the point is simple. I do not believe it is death, although I wish it was because I like the 100% I-O path better (but it takes some extra time and I know the issue with that) because in the long run it is better and it doesn't need that much time as some think.
Worsley's 'coming year' statement is certainly something they will ALSO do, but I am under the impression PPHM wants us to think 2nd ln NSCLC Docetaxel+Bavituximab is death (CEO King's statement - we stay out of NSCLC because it is crowded etc).
I didn't know a while ago that a BLA could be filed at any time as long as you can make the FDA approve it. But it was also only recently informed what I posted before, that the 77+77 patients from the SUNRISE 1st look-in are VALID data results.
So we had a REGISTRATIONAL PII 2nd ln NSCLC Double Blinded Placebo Controlled clinical trial with only 81+40=121 patients and here we have REGISTRATIONAL PIII NSCLC Double Blinded Placebo Controlled clinical trial with 77+77=154 patients.
So if IBM can explain what happened with the control arm and use whatever it is of guarantees they have in the SUNRISE protocol that protects them against approved drugs since start of SUNRISE (e.g. Opdivo/Keytruda 3rd ln treatments) the 2nd ln NSCLC Docetaxel+Bavituximab is FAR FROM DEATH.
So UNTIL PPHM tells us that they will STOP the 2nd ln NSCLC Chemo+Bavituximab studies, and hence back out and say that they will NOT FILE for approval (=no BLA), I am going to refrain from allowing me to think it is death. I made that mistake already once when I started posted about the sabotage and that I was so closely looking into that (ask PG) that that I didn't see coming the PIII design approval and the Fast Track from the FDA.
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