Avid Bioservices Inc (CDMO)

[exwannabe]

The results from the Threshold Pharmaceuticals TH-302 pancreatic phase 2 trial are very interesting. The MOS was very good a 9.2 months but the results for the HR and associated P value were very bad.

True. But the OS results can also be muddied by the cross-over (control patients receiving 302 after progression).

One could speculate (and that is all it would be) that the MOS looked OK, but then the cross-over effect was able to push out the OS for those who lived long enough to benefit. Say it pulls the curve up, but only after 9 months or so. No effect on MOS, but kills the HR and P.

Alas, one can not look at the coss-over and non-cross-over subset as there is a huge bias in this (patients that are too sick can not cross over and will likely die early).

What I find real interesting is that even with the bad HR and P value results, the FDA granted a SPA for their upcoming phase 3 trial.

The primary endpoint was progression free survival. That was stat sig and clinically significant. In a P3 the FDA could well have an issue with OS not looking good (depending on the nature of all), but for a P2 many trials are not designed to be anle to detect an OS improvement and that is not held against them.