Avid Bioservices Inc (CDMO)

[entdoc]

volgoat, I didn't get the feeling the blame has changed. I got no feeling about that at all. However, one day after BlackMonday I said, "do the math", and I'll say it again. The reality is that when looking for efficacy and safety, there was obviously tumorcidal activity in Bavi, and probably acceptable side-effect profile, regardless of all the possibilities of massive/slight over/underdosing or even mixing with placebo. That is basic. This was a dosage study, though, and that is problematic...and will remain so. I've also said before that the biggest issue is whether there was staging "creep", with some less advanced cases in the study. The answer to that is, if randomized, the "creep" should affect all groups equally. Another way of saying all this is, suppose an FDA officer says to SK, "It appears Bavi has anti-cancer activity and acceptable safety. You did a PII to establish optimal dose. What did you conclude in that regard? What dose level do we use for PIII?" All the above imho only.