Replies to post #110035 on Avid Bioservices Inc (CDMO)

[Robert C Jonson]

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).


So does a company in a clinical trial deny cross-over treatment until they know the trial has been/will be considered a success? Seems like it would be taking a big chance otherwise.

[mojojojo]

ex,

Again and IMO, the bad HR and P value results for the TH-302 trial was probably an unfortunate fluke and that type of issue probably isn't going to happen with the bavi trial. Also, there is no cross-over in the bavi trial.

I brought up the point about the FDA granting a SPA for their phase 3 trial because, IMO, the FDA could see that there was an issue with the control arm and took that into account as part of making their decision.


All IMO,

mojo