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Endocyte, Inc. Message Board

  • paintball_is_stellar paintball_is_stellar Feb 5, 2014 7:50 AM Flag

    We're still on the COMP agenda

    for this month. Hope we get approval from the CHMP this go around. I'm reading for this month's earnings conference call. I would like an explanation on everything.

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    • Here we go:

      google: ema comp agenda

      COMP meeting is 4-6 Feb with the Dx + vintafolide on the agenda for discussion

      I guess that CHMP could decide next month on its recommendation should this month's discussion at COMP bear fruit.
      If we are extremely lucky, however, COMP's conclusion this week could directly be funneled into the CHMP meeting to be held later this month - no idea how bureaucratic or speedy the EMA processes are

      Sentiment: Strong Buy

      • 1 Reply to mt_cervin
      • ECYT appears on COMP agenda bcoz COMP keeps track of the drugs to which it assigned an Orphan Drug Designation.

        COMP has no more role. Ball is in CHMP's court.

        Ron Ellis, CEO and president of Endocyte: "It is our expectation that the oral explanation will occur in the first quarter, and if we are able to address those questions completely, an opinion from the CHMP could be rendered at the following monthly meeting."

        So approval not coming anytime before March. I believe it will be April.

        But wait ! we have phase 2 NSCLC data due in late 1Q.

    • How do you know this, the agenda isn't out yet? Got a mole inside the EMA? LOL

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