Avid Bioservices Inc (CDMO)

[exwannabe]

The FDA does not consider historical OS comparisons reliable. They give several reasons for this.

Here is just one that would apply to this case. Those historical comparisons do not have patients using the newer OI and targeted agents as 3rd line treatment following progression. This trial very likely did.

One can rail against the entire system being imperfect, or even as geo does and claim it is fixed. But it is the system. If the treatment does not best the control, that is bad.

Hope all you want that Bavi can show some promise in the early CI combos trials. But expecting an approval (or even submission) based on this trial is only deceiving oneself.