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AVEO Pharmaceuticals, Inc. Message Board

  • ubcprof ubcprof Mar 9, 2013 4:32 PM Flag

    May 2 FDA panel/public meeting

    Anybody knows what the process is? What happens at the meeting? Will anything be announced after the meeting or do we have to wait until July 28? FDA decision is by July 28 so will we find out sooner than July 28? The May 2 meeting is sooner than what AVEO expected according to AVEO's CFO.

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    • The May 2 (and it is 2) meeting is ODAC. This is an advisory panel of "independant" experts who will be presented with the FDA and AVEO presentations, then discuss the issue. At the end they will (usually) vote for/against on both efficiacy and safety. These are not binding on the FDA, but strongly tend to reflect how the FDA will act a few months later.

      Two things to watch for other than the yes/no votes.

      A) About 2 days before the meeting the FDA will publish their briefing papers. This is the first time we can see for real what the FDA thinks. It will be crtical (that is their job), but hopefully no big bad surprises.

      B) The discoussion on OS will be important. My guess is that the FDA staff will have the opinion that there is simply no OS data yet The commitee might lean a little either way, and one will need to hear the discussion to know what they are thinking.

      The meeting will be webcast (I think).

    • a date (panel review) has been set for may 7, so yeah

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