Avid Bioservices Inc (CDMO)

[Carboat]

You do not believe a trial stopped for futility has failed?

he FDA can conclude that the control arm had provisions built into the trial that IF patients were lured out of Sunrise for another drug such as Opdivo (that manipulated the trial comparator control drug of Docetaxel, THEN there could be provisions to modify the control arm and use historic Docetaxel MOS results vs the Bavituximab+Docetaxel arm that "PERFORMED AS EXPECTED"

The FDA is going to use historic data for the control arm as opposed to the actual results? Has this ever happened in the history of trials? Even IF some patients got Opdivo it does not matter. If Opdivo and Doce performed better or the same (looks like control performed equal or better than bavi) then there is no room for bavi at this table.