Avid Bioservices Inc (CDMO)

[Protector]

bidrite, that is two questions.

On the last one, only PPHM knows if they file a BLA or not. I have been entertaining that the could from an FDA point of view and that they have a data collection and IN PROTOCOL (Sunrise) provision that should suffice to convince the FDA while that is of course never a guarantee.

As for the other question:

Does stopping ALL chemo trials give any indication as to the probability of us actually having enough credible data as to file a BLA?

I think ALL chemo's are stopped because there will be a number of problems due to market landscape changes. For starters there will be other possible SOC changes and 3rd ln treatments. In the end Opdivo could be prescribed off-label.

Furthermore the time-line if you start a chemo in PIII NOW (let alone you first have to sit out an ongoing PII) will be to late. I-O will be way further. Finally, as I posted before, Chemo+Bavi is MARKET disruptive and endangers the investments in I-O and all BPs combined we are talking billions here. That is why, while I wrote that PPHM could file for a BLA in NSCLC, I personally hoped they didn't. But OK, no control over that.

Also from the financial point it is more interesting to invest in I-O when AstraZeneca provides Durvalumab. And in the new PPHM strategy (with PPHM only running PI themselves) and then with those results monetise the pipeline in a more strategical way (as I also wrote in a long :) post) would not fit with running all the chemo's along.

But don't get me wrong: I would have been as happy as you would Bavi had a beginning career in chemo combo's with a related PPS reaction. It would have been faster but with lesser leverage then the road they go now, which will be longer but has MUCH more potential because BP's have to score with their I-O pipelines and all significant ones in this area invested in the same PD/CTLA approaches. They need differentiators.