Avid Bioservices Inc (CDMO)

[nuke661]

jakedog,

Thanks for this link and info. Great stuff to know especially for us Peregrine investors in our current state of affairs. These are the key excerpts for me so far:

But AstraZeneca needed a home run here, and it's claiming a bunt. Getting to home base now--at least in lung cancer--will evidently depend significantly on its success with combos.

AstraZeneca CEO Pascal Soriot has had to caution analysts recently to expect delays in its program, saying that regulators are less likely to feel an urgent need to approve new checkpoint drugs now that the first are on the market.

The company's issues with durvalumab may also help explain why AstraZeneca pushed ahead with a rich, $7 billion deal to buy Acerta, and may indicate that more new deals lie ahead. AstraZeneca projected peak sales of $6.5 billion for durvalumab when it laid out a plan to boost revenue to $45 billion in 2023. If that drug falls off the fast track, the Big Pharma will need more shots on late-stage goals.

There are things here that cause me concern and things that make me more hopeful in closing a deal sooner.

The concerning thing is that I'm hoping we aren't hitching our wagon to an under performing anti-PD-L1 checkpoint inhibitor which will eat up our precious resources while achieving less than optimal results than if we spent more of our money and bought the BMS (when you here me say BMS you need to picture me cursing their name and spitting on the ground) or Merck drugs for our new trials. Along these lines I'm worried that we may have only spent half the money but will get subpar results but, if we'd spent the money for a better performing drug then we may get results that better impress the BP world and the FDA. All of that is conjecture or course.

The words that alleviate some of this concern are the words which imply that because there is a checkpoint inhibitor of AZN anti-PD-L1 type already approved (e.g., Merck's Keytruda) the only reason that AZN's Durvalumab won't achieve speed to market is because the regulator's require higher levels of proof for follow on drugs of the same type. I believe that what AZN is saying is they won't get quick approval because the bar has been raised, and it will take longer to prove they are better than current SOC. If you remember the Keytruda approval letter said that Keytruda had not "proved" they were better and required further validation but they were first to make an impression of there being something there so the FDA gave them first crack at the market. Therefore, if true then it doesn't mean that we partnered at this critical time with a substandard drug, it just emphasizes more as to how important our drug is to AZN. Cha ching!!; especially if we become the critical player to achieve those 45 billion per year revenues by 2023. Yeah, I'm guessing AZN's fuse is even shorter than I was thinking when I wrote those posts yesterday. With all the risk they have due to being late to the party then maybe that Sunrise 1st interim look-in data will have a lot more meaning than I thought. Maybe AZN will have more fear filters on their eyes when evaluating that data.

I don't quite understand this logic; if Durvalumab proves efficacy to at least the level/power that Keytruda did then why can't AZN also get the same access to markets as Merck did with Keytruda, of course while also having to prove out the product per FDA requirements. If this kind of logic is really in play with the FDA then it again makes me mad as hell thinking about the phase II trial sabotage and how detrimental that has been and continues to be for Bavi. I still personally believe that Bavi+chemo has a solid chance of equaling or bettering Opdivo's NSCLC results and doing so across the entire population and not just being classified as efficacious to a limited ~ 20% subset like Opdivo is. But, because Opdivo got approved first now Bavi seems to have to achieve a higher standard. I hope the bit about not being limited to a small subset of the population removes that extra burden for Bavi. This thinking is all geared towards Bavi getting its own approval separate from any other drug combo trials.

Thanks again for this info Jake