Replies to post #130510 on Avid Bioservices Inc (CDMO)

[ImaPseudonym]

Only 60% of subjects in the trial have died. They usually wait until more have died to report median survival so that the reported number will be less subject to further revision (censored/uncensored) patients.

60% having died is early given that bavi has showed late separation in KM curves. That they didn't want to wait to see suggests that either 1) even if it had been good, they now have other plans in 1st line and wouldn't have used this combo again, or 2) they know enough to see that there won't be any late separation. (Probably other options, but these are the most straight forward).

[entdoc]

geo, the $64million dollar question. It appears there is nothing to be gained by pursuing the 1st line study if the control group is a statistical outlier, a finding which puts us in the same statistical category as the flawed 2nd line NSCLC trial which (miraculously) the FDA gave us the nod on. Obviously nobody involved could withstand the fallout of another weird control group outcome. My guess is they are seeing increased months of survival in both groups, and have connected the dots. Increased months of survival for terminally ill patients. That translates to clearing the boards and bearing down on the pathway that has been opened to us. The trial results/numbers for 2nd line were quite compelling, and would probably have resulted in fast-track if not for the coding errors. Thank God for PPHM wholly owned subsidiary, MAB producing Avid. A facility that allows PPHM to crank out top quality product and obtain it on very favorable terms. For those ready to pull the trigger I would caution that the PIII go-ahead is not hamburger. Its not an accidental observation. From the genetic engineering lab to the rat lab to the human lab the safety and efficacy have held true. If it's not an H-bomb against far-advanced cancer, it has proven to be noticeably subversive.