Avid Bioservices Inc (CDMO)

[bimerkjaere]

Where we stand after the 2nd line update is a bit uncertain. While the 11.7 month MOS (p<0.217) is very impressive, the reality is that BPs may want more confirmatory data before signing any agreement due to the nature of bavi's MOA and target. I could be wrong on this, and perhaps any potential BP is just waiting for the FDA go-ahead on PIII. However, I am sure that potential BPs are waiting for the final OS results from the 1st-line trial. If we show something similar to 2nd-line, maybe a 40% or more increase in OS vs. C+P (e.g. C+P at 10.5 mo, B+C=P at 14.7), then this would certainly provide enough validation to partner on both indications (would drive SP north of 6 IMO).

However, if we come in at something clearly not beneficial in 1st-line, lets say <20% improvement, then I think we will have a hard time moving bavi forward without better PII results (possibly other indications).

Also, the decision by the FDA is crucial, and I believe this will go in our favor. As Garnick points out, the trial did accomplish dose identification for PIII (3mg) with continued excellent safety profile and good OS benefit. The only way the FDA asks for a re-do IMO is if they do not believe the studies done by pphm were adequate enough to rule out 3mg involvement. If no questions on investigation procedure and results are accepted, then I believe there is nothing to worry about.

Although, just because we get a go from the FDA doesn't mean we have the funds to run a PIII ourselves. This is were the 1st-line trial could help push the balance in our favor and lock down the license agreement.

IMO