Replies to post #273191 on Avid Bioservices Inc (CDMO)

[Bungler]

The two most important phrases IMO: "statistically significant" and "meaningful improvement." What else is required?

[vinmantoo]

In your post look at the control arm Docetaxel alone, just like with Opdivo vs Docetaxel alone, the control arms of actually VERY BIG clinical trials of BMY/Roche are all below the historical 10 Months. In the Opdivo trial it was 9.4 and in Roche/genentech's it is 9.7.

So if PPHM says that in Sunrise the Docetaxel control arm drastically outperformed then rest assured that that we are not talking about 10 or 10.5 months. Well actually after the presentation the guessing will be over.

I think exwannabe is on target in terms of control arm mOS. It will be in the 10-10.5 month range.

Then to have, even if it where a sub-group, a statistical significant survival of Bavi+Doce over Doce alone would point to an UNSEEN performance increase.

Does anybody even has an idea what it takes to just become stat. sig. on a MEANINGFUL improvement on a NORMAL control arm?

In post-hoc data mining, it isn't difficult to find a subgroup defined by a biomarker that performs better in the treatment arm vs the control arm. You juts need to look at a lot of makers and you will find one. The pint is you have to test it in a new trial that contains patients with that biomarker or highly enriched for that biomarker.

However, IF PPHM can start commercial sales even on a sub-group of NSCLC patients then the drug will be on the market and can be prescribed. It will then not take much to have, as some one suggested, in parallel a confirmational small clinical trial that uses biomarkers to shorten the execution track.

Not even close to accurate. There is no way in hell the FDA will allow Bavi sales based on post-hoc data ming from a trial stopped at the first futility look in. It will take a good sized phase III trial for approval. What remains to be seen is whether PPHM makes the same stupid error like they did with Sunrise, rushing into a large and expensive phase III before running a confirmatory smaller phase II trial. They don't have the money for a large phase III trial so they will be forced into the latter. Of course this is all predicated on how many patient had the biomarker and whether or not is makes sense from a biological perspective.