Avid Bioservices Inc (CDMO)

[masshysteria]

Dear all - many greetings for a healthy and prosperous year to all across the spectrum of intent from short to long to agitators and the like! I would love to wish that everyone get what they are looking for in the Peregrine department but that would constitute an inherent conflict...

So we pray for the patients first and let the outcomes align with what works best for them and their well being. A very special shout out for you Krak and hopes for comfort, well being and recovery.

We will stand in line and get our respective rewards as a cascade effect of those results.

Wanted to share a quick thought regarding trial enrollments, and while the current focus in on Bavi/Doce P III for Lung Cancer, this stands as point of consideration for all future and present trials.

Check the attached chart as the background.



Quick summary - see the rise in the Oncology clinical trials intensity (rate of trial registration) for four of our most discussed products, as well as get a glimpse of the total trial registration across all cancer trials globally. The message is clear.

1. There is intense competition for patients
2. The big boys are expanding research exponentially
3. Oncology clinical trial rates in the US, as example, are potentially vying for in access of 10% of the annual new cancer cases in the country.

When considering that most patients do not have access to clinical trials, are not qualified, have a care provider that is 'not with the times' nor 'connected' and therefore does not offer that as an option - one can see where a strong infrastructure of trial planning and execution is key. One can also see that just 'aiming' for a high number far from guarantees you results. Considering you're competing with companies who have hundreds of millions to a billion or two in $US invested in trials alone.

Bringing us to the moral of the story.

But before that - the fine print.
This is not a protectionist piece on behalf of longs, in support of Peregrine, or in covering for what some might consider a missed date or volume of enrollment. It is purely a view of the landscape as it stands and the takeaway that, in this industry and type of work, there is rarely black and white, and grey constitutes most of the outcomes. Most of the time - grey is quite a good achievement.

Now the moral;
In light of the fight for patients, and the hockey stick enrollment (great work by tradero, golfho, CP and others showing the uptick in enrollment during 2015, and therefore large patient volume pressure during last year), Peregrine was competing with the most exotic products and powerful companies and institutions.

It was also enrolling an unknown product (Bavi), with an unknown/not understood MOA, with Chemo, which is a legacy treatment, against the like of PDx inhibitors which became the be all end all of the cancer fight. What do you think would take a doctor to swing a patient to the left door for Bavi/Doce (unknown/chemo) vs. fight like hell to get them to the sexy PDx products that seem to be (and are) producing great results?

Reaching the milestone of 90%, whatever the actual number is, should be taken as a monumental achievement. Wherever one stands with regard to disappointment, ambivalence, or excitement related to achieved enrollment - we should all recognize that it took tremendous effort not to mess this one up. What's implied but is not expressly understood is the power and pressure that large players exert on the clinics and large research organizations - which are typically the pathways/channels for patient recruitment. These are invisible forces (not sinister - to be clear. Only natural progression of business as a customer will be prone to address the needs of the larger hand that feeds it when conflicting demands arise) that wreak havoc in many trials and research operations.

We are in the clear for this phase of the work.

Outcomes are now based on executing the trial reliably and keeping an eye on all the moving parts.

With the AZN Durvalumab/Bavi combo trial set for 1Q start - chances are Peregrine is letting sites get to full enrollment prior to 'converting' or 're-setting' focus on the new trial. Creating competition within the same center would naturally swing new patients towards the more modern IO/IO combo and put final enrollment of the last few patients at risk.

Best to all and thanks again for the countless hours spent on research, sharing and passion involved.

This can get to be quite the addicting hobby if not well controlled!

MH