Replies to post #266433 on Avid Bioservices Inc (CDMO)

[cheynew]

You'd think they could at least file an effing 8K for the dismissal of the CA. We do, after all, have an in-house counsel who has been totally ineffective (even damaging) with his lack of expertise. Even he should be able to file a simple 8K.

[Protector]

RM, I have heard nothing about a new MOA for Bavituximab.

And here again you are mixing up Bavituximab that in its synergy with Docetaxel performed as expected and confirms PPHM's expectations and the fact that the clinical trial SUNRISE (only one in the 2nd ln NSCLC study) was stopped because the control arm, Docetaxel+Placebo, outperformed dramatically ( ref. PPHM PR) and thus did something Docetaxel alone could NOT do (as we know from tons of study and field information that is available for Docetaxel). The IDMC advised it and PPHM took the advice and is no checking what the real numbers are, leaving ALL possibilities open to move for a BLA.

By the way, what few people know is that a sponsor can just arbitrarily stop a trial (provided he finishes ongoing treatments) if he enrolled the minimal require patients as per FDA protocol and file for a BLA on available data. It is the sponsor that takes the risk of having or not having sufficient convincing power and data to motivate the FDA into approval. An early stop, for futility or even efficacy, doesn't change ANYTHING to that. Even with efficacy the sponsor must file and can see a BLA non approved. The IDMC does NOT come in place of the FDA approval commission.

If Docetaxel COULD do, CONSISTENTLY what it did in the SUNRISE clinical trial then Doctors diagnosing and at some point patients in 2nd NSCLC should REVISE there SURVIVAL expectations when they inform patients and YET THEY DIDN'T! Nothing in the SURVIVAL expectation with Docetaxel treatment has changed simply because the control arm in SUNRISE was an anomaly. The Opdivo control arm proves that, as to the studies such as Herbst et al, 2012 and others.

Furthermore Opdivo would not be approved of Docetaxel could consistently perform as in SUNRISE. Only in the Opdivo trial the control arm under performed compared with the two higest results reference studies.