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Thursday, June 16, 2016 7:44:11 PM
You know there is a separate pseudo arm in the randomized trial.
It was to have had about 48 patients in it.
In May 2014, there were 32 patients and they stopped enrolling pseudos into their separate arm. Then in August 2014, the company announced the trial enhancements. We weren't told anything about the pseudo progressor number having been changed as it really never was public knowledge their was a pseudo arm. We only knew it because some had gotten a peek at the leaked protocol - me being one of them who got more than a leak.
A month or so after that August 2014 enhancement announcement, Linda or someone else was giving a presentation and on one of the slides, it showed there were 32 total patients in the pseudo arm.
So why go from 48 to 32 when they were increasing the size of the main arm - the main arm having hopefully, no pseudos and no rapid progressors. It makes more sense they'd increase the pseudo arm to match the increase in the main arm.
Unless the pseudos were showing such progress that it was decided it was wrong to continue enrolling them into a trial where they had a one in three chance of being put on the placebo first.
So that represents the gist of what I was writing earlier.
Then I was only suggesting to flipper that AFTER what ever is going on is done and announced, if it does involve the pseudo arm... they may be able to show the data in the EAP trial. It's open, and its participants are primarily rapid or pseudo progressor patients.
The EAP has been where all pseudo progressor patients go after May 2014. Their data would be available to the sponsor because this trial is NOT blinded. If the sponsor was asking for approval for pseudos and/or mesenchymal, they may be able to use the pseudo data in the EAP to help support their request for approval.
I only bring the rapids into the conversation with flipper because if they choose to share on EAP data, it won't necessarily reflect how the main arm patients will respond to L because there are no rapids or pseudos in the main arm. So sharing that data with the world might not compromise the blinded L trial. The statisticians of the world would know better than I.
Hopefully, that makes sense. If this is what you thought I meant, well... that's okay, I didn't mind writing it again. :)
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