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Ready4bluesky

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Ready4bluesky

Re: flipper44 post# 46251

Wednesday, 12/02/2015 1:39:33 PM

Wednesday, December 02, 2015 1:39:33 PM

Post# of 708084
Flipper, quick question. In your opinion, would it be possible to use data from the information arm trial, such as OS, as supporting documentation with the application "package" for AA? I know that it would be different patient criteria than the randomized arm, but it seems if patients with a worse prognosis are experiencing an OS benefit (vs. historical norms), it is additional proof of treatment effect. Hopefully it would accompany robust PFS data (and some amount of OS data) from the 1st IA. Thoughts?
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