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03/02/16 8:24 PM

#55778 RE: Ready4bluesky #55773

"She (Linda Powers) talked about accelerated approval and said that they can't apply for it until the trial reaches its end."

This had to have been some sort of a misunderstanding between the two as the point of AA is that you don't wait until the end. Avii has given examples that seem to support that full enrollment must be reached first.

'Course, I think it's fully enrolled, so there you are.

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flipper44

03/03/16 12:49 AM

#55798 RE: Ready4bluesky #55773

Hi Ready. I know it must have been painful for you to say someone on this board stated LP said AA was off the table, only to learn they stated it was on the table. Funny how "fantasies" become reality.

"She (Linda Powers) talked about accelerated approval and said that they can't apply for it until the trial reaches its end. -- beartrap"



You must have thought because they weren't applying for it in December 2015, they were not filing at all for it in this trial. Ready, the option remains on the table for all we know. Whether they decide to use it likely has to do with what is going on right now.

The point at which they formally apply, if they do, likely has to do with any commitments they might or might not receive from the FDA, and of course whether they need it or not. When a surrogate endpoint is reached (Example: SS on PFS), the trial may end -- or not; and convert to a confirmatory trial, or not. Although I believe LP may have confused the wording a tad, she clearly did not eliminate AA as an option.

What was that you previously said?

Don't play coy. You know what I'm talking about. Enough with the AA fantasy. It's not on the table! -- Ready



Better luck next time.