Avid Bioservices Inc (CDMO)

[Protector]

Almost 24H no sleep and still missed the PPHM ASM.

But in a few minutes I'll be asleep like a baby because in a quick scan I see djohn and eb did make it to the PPHM ASM.

This is what I think to understand (didn't even hear the audio stream because I was in the car driving back to Vegas at that time) so it is from this board and the PR.

1) PR AstraZeneca
A 2nd clinical trial with AZ (PPHM runs it) = consistency. The PD-L1 also for this trial delivered by AZ is a MAJOR cost cut. A PII can have 100+ patients and 150k$ x 100 = 15Milj$ saved in buying Opdivo, faster and better access (BMY will NOT be able to create supply problems when new patients become available and so delaying the program). Unless Yevoy+Bavi is spectacular I expect that trial not to continue in a PII either.

Peregrine had initially been planning to test bavituximab with Bristol Myers Squibb’s Opdivo in the same lung cancer population, but says the combination with durvalumab will allow “a much more cost-effective and time-efficient trial”.

Now that makes my day :) That means AstraZeneca isn't just there to watch the furniture.

More importantly the 2nd AZ clinical trial is for LUNG. That means PPHM has the Docetaxel, Paclitaxel and PD-L1 solution for LUNG covered and notice how this trial is for both squamous and non squamous.

a global Phase II study in patients with previously treated squamous or non-squamous non-small cell lung cancer (NSCLC)

This Phase II study offers several key advantages including a supply of durvalumab that will enable us to conduct a global trial that can enroll patients more rapidly ... In addition, the expanded collaboration provides for a more cohesive clinical program utilising the same PD-L1 and other biomarker analysis across both the new Phase II trial and the already planned Phase I/Ib study combining durvalumab and bavituximab in multiple indications”.

What is happening here is within a BROADER context, you can feel it that from the language used. AstraZeneca did not venture in this to conduct yet another trial and play Santa because they had some durvalumab left overs.

I wonder what Dr. Stopeck may have seen in her Bavi-combo test (for HER-2/3 patients) that is not there with Docetaxel. This PII/PIII trial is still to start and I would not be surprised if we loose the PII leg of the trial before it starts. I am almost sure the Doce+durvalumab+Bavi PI for solid cancers will have a fair amount of breast cancer patients. AZ will push as many of the big solid cancer type patients in that trials as they can. See how PPHM keeps emphasising: none-exclusive. I like that, they clearly start to get in control.

2) Avid
It is clear that the FDA doesn't consider Avid II the same facility as Avid I or they would not need FDA certification until the next inspection (extension of existing facility). Given this is a completely new type of facility I figure PPHM wants it certified. 5 weeks is not a long time. In December we'll see the back-log and the new orders forecast and I think we will be surprised.

3) Vote
I am glad that is over and done with. Now practice will show if PPHM uses the ATM as they did before, with reason and when needed. I think we'll see an extension of the poison pill, not extending it would be suicide.
Also glad that some that were there confirm that SK and ES are not anti-shareholders. That is a FALSE image that has been created here on IHub by some probably based on the, lets call it at the most unfortunate, statement of SK that they would not run the company in function of the share price.

Time for sleep now. I am waiting for OCT 25th 2015 and see if the Doc shows up to change our world :)