Replies to post #200531 on Avid Bioservices Inc (CDMO)

[biopharm]

thanks sunstar, very encouraging and the two country locations that stand out for me would be Spain and Greece.

Good luck and Bavi treatment to all lung cancer patients taking part in this trial.

and to be politically correct:

Happy Holidays to all : )

[swg_tdr]

Are we approaching (450) patients treated: 225 per arm now?

or (300) patients treated: 150 per arm now?

well Sunstar, did anyone find any site where it says "no longer enrolling"???

long way to go yet

imo,
N

[EYEBUYSTOX]

Peregrine wants to see certain data that can be used as surrogate endpoint(s). These data could, conceivably, break open the trial and precipitate an FDA Accelerated Approval, AA, for BAVI in lung cancer.

That's false IMO. With ramucirumab reaching a stat. sig. OS benefit in combination with Docetaxel vs. Docetaxel alone across histologies there is zero chance that PPHM would file for approval using either of the listed surrogate endpoints of ORR or PFS in SUNRISE. Just ain't gonna happen.

But AA and use of surrogate endpoints is certainly on the table for melanoma, breast and/or liver. But there's that funding problem again.