High CV? [Design Issues]

posted by d_labes  – Berlin, Germany, 2016-05-03 21:07 (2292 d 14:20 ago) – Posting: # 16276
Views: 6,878

Dear Helmut,

» Adding to Detlew’s wise words: For a CVwR of 54% I would expect no inflation of the TIE with the FDA’s RSABE and practically none with the EMA’s ABEL.

where did this CVwR you mention came from? I couldn't detect such a number in this thread. Did you use a crystal ball [image] to figure it out in M.tareq's post? Or do you have some insider information?

Regards,

Detlew

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