Reversed procedure? [Dissolution / BCS / IVIVC]

posted by The Outlaw Torn – Europe, 2018-07-04 11:50 (1126 d 13:03 ago) – Posting: # 19018
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Thank you Lampshade! :-D LMAO at the video...got to watch the movie!

Very comforting that you see it this way too. And I found a precedent where the CHMP ruled on this very issue during an arbitration hearing, though the initial application was 10a and shouldn't have been eligible, or needed, to use the BCS biowaiver option.

I'd love to go to Prague. Love it the first time I went. I'd noticed that Henrike Potthast would be there and worked on ICH M9, with Jan Welink from the EU side. Might be able to convince someone around here that it's worth attending! Thanks again, Helmut.

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