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sentiment_stocks

02/04/19 6:06 PM

#212768 RE: longfellow95 #212746

I think you may be forgetting PFS adjudication.



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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notbrad

02/04/19 7:45 PM

#212792 RE: longfellow95 #212746

Longfellow,
Are you sure it takes a year to do PFS adjudication ? I don't know, that's why I'm asking.
I was thinking...you put 3 independent experts in a room. Say they review 10 sets of scans a day (is that too much, too less?). For 331 participants, that's about 33 days or 7 weeks. We will be paying the CRO who will pay the experts. So they better show up, right ? Or are these people with regular jobs who can only devote a couple of days a week. Besides, not all would have progressed, so we could factor that into the time estimate.