Replies to post #257414 on Avid Bioservices Inc (CDMO)

[geocappy1]

Do you have any examples of any large BP drugs where the control group outperformed a treatment group that was performing up to expectations?

it seems only to be the case when there is a biotech worth less than $300M with no BP partner.

[asmarterwookie]

those who were randomly given the drug were not<ADD:sufficiently> living longer

According to the PR.

Just sayin.

wook

[jq1234]

>> 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.



SUNRISE was based on even more sketchy ph2 data. ACT IV was based on several single arm trials, the trial design was based on so called "SOC historical control" which is always unreliable in oncology, and now proven incorrect assumption of EGFRVIII with worse overall OS in GBM.

The similarity between CLDX and PPHM was their SMALL randomized ph2 trials, neither trials were powered for OS, neither stratified during randomization of baseline characteristics that affecting OS - in PPHM case including region/race and prior therapy since platinum-based doublet chemotherapy not mandated - thus resulted severe imbalances between arms. The OS benefit was a mirage that couldn't be reproduced in larger ph3 trials.

Read this post and replies from 2014 on ReACT and ACT IV shortcomings:

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=108209114

You can find even more skepticism regarding PPHM ph2 trial result on Biotech Value board from 2012/2013:

Before known mix-up of placebo and 1mg/kg arms: trial missed its primary endpoint of ORR, placebo arm had worst AE profile, 1mg/kg arm was the best performing arm based on OS HR.

After known mix-up of placebo and 1mg/kg arms: how could the mix-up arm 1mg/kg produce statistically significant HR while not mix-up arm 3mg/kg couldn't? High dropout rate on 3mg/kg arm confirmed by final analysis presented at ASCO 2013.

SUNRISE: stratified, mandate of prior platinum-based doublet chemotherapy, HR likely under 0.8 based on trial size and 2-month improvement in mOS improvement assumption => futility, no surprise!