that has shaken the tree, page-49

to Kenny Powers and All (who are interested not just in the sp ups and downs :) )

I'm far from happy re. the slow ramp up in the initiation of the sites for CANVAS (to be correct I'm not happy that they change and push initial timeline as the time goes by which affects all other milestones) and I was bringing it up couple of times here.

Also I raised it with ML and below is a response I got back in early September.

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"The overriding factor for starting sites on the CANVAS trial is our need to implement very strong training and operating procedures for each blood collection center. The blood collected from each patient is a critical starting material for manufacturing our CVAc product. Additionally we constantly monitor a number of factors such as quality and experience of the doctors, the availability of patients, and associated costs when adding sites to the trial. We anticipate that we will finally utilize about 130 sites but we are now starting with about 100. There is some fluidity to the final number of sites that we will chose to participate.

We are highly attentive to the quality of the conduct of the CANVAS trial. Given the level of investment we have made into this project, our first priority is to assure the quality of each product made and the integrity of the data we receive from the study.

...

Overall, there has been a significant amount of progress made in the last year and we receive a lot of positive feedback from the doctors and patients across the world."
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In simple words, the #1 priority for the Prima team is QUALITY (and not speed) in the start up of a new site.

Nevertheless, on the cons I'd note that not all EU countries gave authorization for the trial yet, they are still waiting for this (and who knows how long it will take to get it from each government => more delays)

And on the pros, given they plan to run ~100 sites, to enroll ~1000 patients, each site needs ~ 10 patients only, I would estimate it should take 6-9 months. So the current timelines are still achievable.