Replies to post #260137 on Avid Bioservices Inc (CDMO)

[Carboat]

Now Sunrise failed because the control arm got Opdivo? Speculation becomes fact so quickly.

[jq1234]

>> Was this in the trial design? At the very least Bavi+ chemo should be compared to a clean chemo trial like the opdivo control arm.


Yes, if you didn't know before you should have. All oncology trials allow patients to take whatever available to them after progression, it is called subsequent therapies. There was no clean chemo arm in Opdivo control arm: over 50% patients on chemo arm went on having subsequent therapies, only 42% on Opdivo arm went on having subsequent therapies. See details here:

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=120957357

In SUNRISE trial, there was no reason only chemo arm patients who progressed went on having Opdivo/Keytruda as subsequent therapies, bavituximab arm patients could too. Some people speculated bavituximab arm patients not eligible to enroll PD1/PDL1 trials, it's nonsense. SUNRISE trial was double blinded, patients wouldn't know which arm they were on, no way affecting bavituximab arm patients differently from placebo arm patients if they wanted to enroll other trials after progression.

[Protector]

tech0200, that is possibly not the problem.

It just would not be ethical to ask patients (in any arm) to let themselves die by not taking any further treatment after progression (if they want) because to safeguard the trial results.

Progression Free Survival (PFS) is another measure but is NOT the same as survival. While you progress you are still alive (hence surviving while having progression).

What is needed is that the APPROVAL TRAIL results must be used (the trial on which Docetaxel approved) and that the FDA should force INDIVIDUAL ARMS for ALL stages and ECOG's the drug want to compete for.

Say, Stage IIIB ECOG, 0,1 and Stage IV ECOG 0, 1 and assign them an EQUAL number of patients through randomizing per comparable arms:

E.g. Compare 70 patients Control Stage IIIB, ECOG 0 with 70 patients Bavi Stage IIIb, ECOG 0 en do the same for the other 3 combinations totalling 520 patients in 4 control arms and 4 Bavi arms. All arms comparable arms would need a same amount patients but they could be different per pair. For instance Stage IV, ECOG 4 patients may be harder to find and therefore such arm might for instance only enrol 30 patients in CTRL and 30 in Bavi.

That would solve ALL lottery situations because same stage and same ECOG would be compared and Progression Free Survival would become the better end-point. And it would not matter any more what the patients does afterwards because it is clear that SURVIVAL alone is today influenced by to many factors that are no longer proper to the drug but depends on the random behaviour of what patients decide to do on survival.

But believe me, if I can think about the above then the FDA and BP could to when they designed the clinical trials. And if it was not designed like that it was to keep the door open for hanky-panky because stupidity is not a valid option given the parties mentioned.