Replies to post #273016 on Avid Bioservices Inc (CDMO)

[peregr]

First-I think you are correct on the future direction.. Partnership on a Ph2 based upon the bio marker data. Reading the 10K, it seemed to indicate that the results of the biomarkers would determine the clinical trial design. That was the delay. We've seen recently some very large premiums in the biotech space to harness a cornerstone molecule based upon Ph1/2 trial results.
Second-Not sure it can be definitively stated that the combined population saw no benefit. Less benefit than the control (at that point), but not necessarily no benefit. In fact, that may be good as that would suggest an even stronger result for the bavi/biomarker data.
ESMO should answer some questions.

At least we have some guidance at this point.

[north40000]

You stated:

" Did the biomarker expressing subgroup do substantially better on Bavi than placebo? Note that the stat sig in the PR does not imply this."

I do not understand why you minimize/discount this portion of today's PR, where PPHM:

".... today announced that top-line data from the Phase III SUNRISE trial of bavituximab in patients with previously treated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) will be presented as a late-breaking oral presentation at the upcoming European Society for Medical Oncology (ESMO) 2016 Congress. Presented data will include a biomarker in the SUNRISE trial that correlated with a statistically significant improvement in overall survival for patients treated with bavituximab in combination with docetaxel compared to patients treated with docetaxel alone.

Docetaxel itself is not a placebo, is it? Rather, it is expected, as a SOC, to have a therapeutic effect in NSCLC[Herbst].

[vinmantoo]

There is a hell of a lot more to know before we can say the data is valuable or not.

. How many biomarkers were looked at? If one was to search 20 random variables one would be expected one to be stat sig.

Right on target.

.
Is the biomarker something that looks like it is real? Something that Bavi could reasonably be expected to work better in?

Bingo.

. If Bavi was relatively better in the expressing group, it must have been absolutely worse in the non expressing group (since the combined population saw no benefit). This would be odd, as nobody here thinks Bavi is harmful. And such oddness leads one to suspect random chance.

Not sure what you mean here. The presence of a biomarker could designate a patient population whose prognosis is poor. A drug might improve their outcome but that biomarker + drug could still be worse than the overall population.

Yeah, IF these concerns are addressed Oct 10. And if, as you say, the population is significant. THEN one could make a case for running another trial in that population. A P2 though, unless they want another crapshoot.

Game, set and match. Excellent post exwannabe!