PE restriction for HVDs/HVDPs [Study As­sess­ment]

posted by Helmut Homepage – Vienna, Austria, 2015-04-22 18:41 (3263 d 05:40 ago) – Posting: # 14733
Views: 11,053

Hi John,

❝ ❝ VSL’s post is ambiguous:


❝ And guess what, he still hasn't replied :-|


❝ But if he was talking about ref scaled, then why would he bring up 90 CI? Strange, actually scary...


Duno. That’s why I asked for more information. He/she didn’t mention a 90% CI, only told us

❝ Study is passed in CI


Maybe he/she meant the upper 95% CL of FDA’s approach (≤0)? BTW, since for the EMA scaling is capped at CVWR 50% passing with a 90% CI and failing on the PE is very, very unlikely.

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