Avid Bioservices Inc (CDMO)

[nuke661]

Couch,

I'm guessing that its going to take a combination of good Sunrise interim data and good ORR data from 2 of the 3 new trials. One of the major reasons I supported (probably the major reason) the increased share authorization was because I was hearing from management that we needed more "relevant" or "more firm" data than we currently have. And, as far as the great breast cancer IST data we already have someone (some BP(s) who count(s)) must want more data than that obtained from 13 patients.

They should get breast cancer started by end of this month and the new bavi + AZN IO by February (of course that's a guess). We don't need big enrollment numbers but, how many I don't know. I would guess that it would be anywhere between 40 and 80 per trial. I would think that getting 40 patients enrolled in Bavi + durvalumab for NSCLC should be a slam dunk and should be accomplished well within 6 months and probably a lot sooner with AZN helping. I'm sure they'll be supporting this trial using their influence and contacts to ensure it is expedited along with providing free durvalumab. As AZN is also supporting the multi tumor types with free durvalumab I assume this extra help will be extended for that trial too.

I don't know how long it would take to get 40 breast cancer patients but I know Moffit here in FL is big in this area and is also involved with Bavi trials. I assume this goes for other centers used in the Sunrise trial as well. I would think that 40 patients for breast cancer should also be able to be enrolled within 6 months because we have established lots of working relationships with large cancer centers via Sunrise. This first phase 3 must have opened lots of doors and created lots of working relationships. This all saves time for quick follow on studies as long as we have the money to keep the process moving along.

I'm guessing that there is a small probability that we get the big deal between now and April but I believe the real high probabilities will be once we have Sunrise 2nd interim which management describes as mid-year. These are going to be open label trials if I remember correctly so new trial ORR data will/should be available day by day. So I believe from June on the probability of the deal closing out of the blue gets much greater.

I don't think there is anyway in hell that there won't be a BP deal with good interim Sunrise data, along with confirmation of superior response rates with anti PD-L1 drug in multiple applications and confirmation of the great breast cancer response rates we've already obtained and all this based on OUTSTANDING pre-clinical translational data.

It looks like management has planned a full court press for this year. We'll just keep delivering great pre-clinical (from MSK too) and multiple clinical data until someone hands us that big check we've been waiting for.