Avid Bioservices Inc (CDMO)

[entdoc]

James, I don't see a lot of room for speculation about the outcome of the Sunrise trial. For instance, it is difficult to speculate on possible failure to randomize the trial cohorts from 160 sites. Even though the Doce + placebo outperformed historical survival times, clearly Bavituximab did not perform well enough to establish it as a valid treatment for advanced lung cancer. This will be the result regardless of Garnick's "post-mortem on the trial and its post-mortem". The biggest area of speculation that I can see for this trial is not what Bavi did or did not do because we have that answer, but whether or not in the future every patient being treated with Doce alone should also be treated with a placebo and told they are part of a clinical trial so that they too have an opportunity to outperform the historical norms of survival with Doce. We definitely did not prove Bavi is better than placebo, but instead re-established the value of placebos. We have learned that Bavi is not going to be used for large (bulky) solid tumors. We have apparently learned it is safe. Examination of postmortem tissues, including Doce alone and Doce +Bavi will provide some insight into possibly using Bavi to prevent/slow growth of micro metastases and to prevent recurrence via active immunity. I suppose the only thing missing from this trial design was a third group of Doce alone without placebo to see if that group would have also outperformed. The above is merely "first-pass thoughts" without much serious reflection. Any counter views are welcome.