Replies to post #267954 on Avid Bioservices Inc (CDMO)

[exwannabe]

That is why a drug such as Opdivo can be approved - and on an accelerated basis - with just a two month MOS increase over best historical SOC results. So of course Opdivo presents "no cure" for the malady - in this case lung cancer - but rather, just an incremental increase in overall survival - with its own set of AE's - and only for that small footprint of lucky folks who actually respond to the treatment.

No. In the entire population it showed a few months improvement. In the patients it worked well in, much more.

Yes, of course it is not a cure. Neither is Bavi.

And the AEs were not as bad as the chemo arm from a practical (patient QOL) perspective.

So if Bavi "performed as expected" as CJ reiterated, and achieving that expectation was designed by Dr. Garnick to allow the FDA to grant approval - as CJ also reiterated - then Bavi most certainly should be approved.

So bavi added to chemo did not live longer than chemo, therefore it should be approved because Opdivo (w/o chemo) only lived 2 months longer than chemo. That argument is a bit illogical.

Re your "futility" statement above: If the Sunrise trial had simply seen a control arm result {9.4 months} exactly the same as seen in the Opdivo trial, do you have any doubt that Bavi would not be approved RIGHT NOW ?

It is a certainty it would NOT be approved right now.

Even in the rosy hypothetical of 11.5 months vs 9.5 it could not possibly be approved before next year. The first look had no efficacy halt built in. The second would have data right about now, and it takes months to get through the process. And I doubt 2 months would have triggered the 2nd look anyway.

Reality:

Bavi failed in SUNRISE. If running an auto race at 185mph is "performed as expected" but came in last, it is not good.

[entdoc]

James, here is a "real-time" lightening strike map. Take a look. Not a single one in California. https://www.lightningmaps.org/#m=sat;r=0;t=3;s=0;o=0;b=;n=0;y=37;x=-100.0762;z=5;
Of course California has lightening strikes, but few compared to the upper mid-west. My point is, and has been for years, that no immunological agent or combination of agents is going to back off advanced lung cancer. such could conceivably hold it off after surgery, irradiation, or standard chemotherapy. Bali is going to be best used in early cancers, and to prevent cancers, mostly through anti-inflammatory properties. You need to hold a large lung cancer in your hand sometime...or at least see one up close. Miracles happen. We've all heard of at least one. Just like lightening strikes in California. On another subject...again...has anyone asked for an immune-pathology report gleaned from this study, or any pathology report to see what Bavi did under the microscope? Pretty important stuff. How about a detailed side-effect analysis? I hear rumors about freedom from side-effects, but have not seen a detailed statistical analysis of, say nausea, bleeding, headache, rectal itching. It seems we have a lot to learn, and there is zero information forthcoming, ir indications that it WILL be forthcoming...e.g. the "subgroup analyses". who gets to see that, and when?