Replies to post #257267 on Avid Bioservices Inc (CDMO)

[thealias2002]

Thank you ..... And great to see you posting more!

One last thought; From everything I've read, our phase 2 really was a phase 3 trial design. The only thing that gave doubt to the data was JB. So, we have 'phase 3' results (from that phase 2 trial) that have been deemed acceptable by the FDA.

Considering JUST the Bavi arm of sunrise as support for the phase 2s results,.... which should support the p2 trial's success,......why couldn't PPHM silently, below the radar, no pr,....file for approval?

Yes, the p3 control arm has to be mentioned and should be mentioned to the FDA, but we would have two trials/arms to prove Bavi works regarding safety, patient benefit, etc., and a decade(?) of Docetaxel literature/trial results to prove the control arm here was not only abnormal but grossly high. Nutshell: Bavi continued to work as anticipated, the trial didn't.

To me, the drug would gain approval if the p2 data was acceptable. We have safety and we have Bavi as acceptable.

I don't care if we are immediately SOC. We have an approved drug that can be added to treatments now.

.02 and IMHO.

[swg_tdr]

entdoc, look again

and I believe one qualification for entrance into this study was that entrants have untreated advanced lung cancer. I could be wrong on that one.

see
Focus: Previously Treated (Stage IIIb or IV) Lung Cancer

my apology if any prior comment on this, as a few here have ecome invisible to me.

best,
N

[Protector]

entdoc, you are wrong with that reasoning.

That assumes that the Bavi arm patients would at the same moment do whatever it was the Doce+Placebo patients did to achieve this out performance.

And if Bavi works, which it does, then that is impossible because the Bavi patients would take much longer to, for instance progress, and would therefore only do later what the Doce patients do now (for instance get a 3rd line treatment).

So we had the look-in into data of DEC 2015 §meeting IDMC JAN 2016, processing and letter to PPHM in FEB 2016). In DEC 2015 the trial was up 24 months and the hockey stick enrolment shows the patients bulk of the 154 patients (77 CTRL +77 BAVI) are only in the trial for about 15 to 18 months.

So you can see many CTRL patients outlive while you see the Bavi patients do the normal cycle. In he MOS table you do NOT see the Bavi patients that take a 3rd ln treatment (and hence will indeed perform and ALSO outperform THEIR trial design expectation) because they are STILL ALIVE. SO it is TOO SOON now.

That is why I posted that I don't understand that PPHM closed SUNRISE so easy because they know that TOO.

[north40000]

I no longer remember actual facts from the Phase 2 trial 2012, but with the control and 1 mg Bavi arms being combined for presentation to the FDA for Phase 3 consideration, is it logical to assume that said control arm as combined also performed better than historical values of docetaxel[e.g. Herbst]? Did it? How much better, if any, did the 3mg Bavi containing arm perform than that combined control arm?