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raja48185

11/07/17 10:23 AM

#41845 RE: ignatiusrielly35 #41843

we will have to wait and see what happens - there are 3 ifs to consider.
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khaled_shatila

11/07/17 10:31 AM

#41846 RE: ignatiusrielly35 #41843

early termination because of good results automatically means earlier approval as you will use these data to supplement your application to regulatory authorities (ie FDA etc )

it is a double win because you have data Earlier than expected and Better than expected
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mypekeispooped

11/07/17 11:04 AM

#41853 RE: ignatiusrielly35 #41843

Ig, You may find this interesting reading regarding accelerated approval.

http://www.healthaffairs.org/do/10.1377/hblog20170320.059267/full/