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Dynavax Technologies Corporation Message Board

  • joeyzazza01 joeyzazza01 Feb 3, 2013 7:17 AM Flag

    DVAX and Europe - CHMP, MAA, 120-day, 180-day, 210-day

    Did DVAX receive '120-day' questions ? Or do we find that out on the 180th day? If we find out on the 180th day, I guess on Feb 20th we will find out whether the EU CHMP has any questions for DVAX and if not, we should expect EU Decision in March?

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    • I've been going through this MAA thing with ARNA and have read a ton of documents relating to the EMA approval process.

      The company announced that the MAA was accepted by EMA on 8/22/12. The clock doesn't start then, it starts on the next scheduled start date which in this case was 9/19/12. Following the calendar set forth by the EMA the 120 day assessment (list of questions) was due 1/17/13. This date coincides with the conclusion of the January CHMP meeting.

      After receiving the 120 day assessment the clock stops. The company has 90 days to respond and after the response is received the clock starts again, not on the date the response was received but on the Phase 2 start date. If the company takes the full 3 months to respond the clock starts again on 4/26/13. At the 180 day mark, 6/27/13 the CHMP either issues it's opinion or sends the company a List of Outstanding Issues.

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