Replies to post #257264 on Avid Bioservices Inc (CDMO)

[honestabe13]

needless to say, i had Celldex (CLDX), too.

[exwannabe]

another control arm outperforms

In the ACT IV study, RINTEGA has performed consistently with prior Phase 2 studies but the control arm has significantly outperformed expectations...

SUNRISE vs ACT iV

. Both futility halted with the same storyline. Drug performed as expected but control exceeded. This is not at all uncommon.

. Both had sketchy P2 data going in.

. Note the CLDX top line numbers that were released. Almost no difference between the arms. This was on the second IA (it already cleared the first). Given that an early IA has an easier futility bar to clear, one would strongly suspect that B+D was trending worse than D to be halted this early.

. CLDX released the HR and mOS numbers. PPHM has not. N40K notes correctly that the DSMB might not make this information available in case the company wants to work with the FDA on a trial decision. But once the futility halt has been called, it is over. PPHM has these numbers now.


The one thing you can take away from these trials is that amongst a large group of similar people, those who were randomly given the drug were not living longer than those who did not get the drug.

And that defines a failure, however some wish to spin it.