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Monday, February 04, 2019 6:06:49 PM
Okay... they likely know pretty much how they're going to go about the adjudication, and have established the criteria by which they are going to determine progression, and are waiting to put it together in the SAP to submit for approval.
I can't think of an argument for why they would wait until after they'd gathered all the blinded data again - for the 5th time now - before they sat down to figure out how they were going to approach this process. Surely they have a solid plan to move forward that has been massaged and reviewed and assembled by LL and Dr. Bosch et.al. They knew psPD wreaked havoc quite time ago, as evidenced by Dr. Bosch's comment at that London symposium he chaired. They had to have examined those MRIs and the corresponding data ad nauseum just to figure out there was a problem. So as I state, I hope by now they have a decently solid plan as to how they going to do it.
Would they have started it before the SAP was submitted? I dunno. But what data did they use to figure out how they were going to approach this ginormous take in the first place? It would seem that their own blinded data would be the best place to start. I mean, they have it so...
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