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posted by Ohlbe – France, 2014-11-28 10:30 (4230 d 20:11 ago) – Posting: # 13943
Views: 4,095

Dear Kumar,

❝ The date for coming into effect for this guidance is 1 June 2015. Can we submit the study as per the old guidance (without pAUC) now? :-D

Yes. The old guideline still applies to any application submitted before this date.

—
Regards
Ohlbe

Complete thread:

EMA MR guideline Ohlbe 2014-11-18 22:55
- Published ! Ohlbe 2014-11-27 19:22
  - Published ! kumarnaidu 2014-11-28 06:20
    - Published !Ohlbe 2014-11-28 09:30
      - In effect 1 June 2015 Helmut 2014-11-28 14:11
        
        In effect 1 June 2015 Ohlbe 2014-11-28 18:29
        
        Accumulation Jay 2014-12-01 11:11
        
        Accumulation nobody 2014-12-01 15:48

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