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Arena Pharmaceuticals, Inc. Message Board

  • k.baker60 k.baker60 Apr 10, 2013 9:14 AM Flag

    EU Mandated Timeline for answers

    Any speculation on when Arena presented the oral explaination to the EU? As we all know, the EU DOES have mandated timelines in which to reposnd (unlike the DEA here in the US, who does NOT have timelines placed on when they are to answer)

    DEA is seriously dragging feet on this as there has only ever been 1 other drug APPROVED by the FDA which took a record amount of time for DEA to respond, Lucerna (350+ days). FDA, DEA; extremely broken systems causing americans their lives. Way to go, you all sure now how to work hard at accomplishing absolutely nothing except job security for yourselves!

    Sentiment: Hold

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    • I dont think that indefinite time would occur with the EU...The clock is stopped for sure as much as we know, while their experts look at belviq...Will they set a oral for arna or not? If/ when they do this then clock would start again but they dont tell us at all.......DEA is just a big joke

    • I contacted EU and they do not report the "day" where this (or any drug) sits. ARNA won't say either. Not sure how a drug can be at Day 180 for months; this seems toflaunt their guidelines for expeditious review. The clock can stop, but seems like it can be indefinite amount of time.

      I certainly LIKE the idea of a timeline and hard and fast deadlines. Sadly, DEA doesn't have one and EMA finds ways around it.

      As SA author seemed to purpoirt, 45 days is the DEA guideline. We are at twice that now. The excuse is that there were so many comments.

      Pretty ludicrous to say that eight, ten, twenty 'substantive" comments multiply the timeline at the DEA from the 'normal' one or two comments. If you make a pot of chili that is 5 times the recipe, does it take 5 times as long to cook?

      • 2 Replies to chrisanja
      • Are we even sure that Arena had to do an Oral Presentation? Last thing I remember hearing from Arena was they may have one, but hadn't been asked yet. Did I miss some news? You make some great points Chrisanja!
        Also, just curious, after Lucerna waited a year, did anything change?
        And isn't a public comment period kind of outdated? Both the FDA and DEA has scrutinized this to death. What more needs to be added. I would bet that 99% of the people including myself, aren;t really qualified to raise ant legitamate comments, other than lets start helping people, and let this go to market!

        Sentiment: Hold

      • Normal timeline for DEA is 6 to 7 months. We are passing 9 and a half months with ZERO indication they (DEA) are actually working on it. No wonder Americans travel abroad for medical care! Substantially more efficiant than in the U.S. (and we're suppose to be the "greatest nation on earth"?) Absolutely not, when it comes to healthcare.

        I truly belive what is happening to Arena is personal against Jack Leif (and have maintained this thought for 3 years). Way back in the day, Jack drew a line in the sand with WS and went against the grain. Today, we're paying the price for that (I believe).

        Sentiment: Hold

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