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Arena Pharmaceuticals, Inc. Message Board

  • pharmaapproved pharmaapproved Apr 8, 2013 11:33 AM Flag

    Someone with more knowledge

    Tell me where we are at with the EMA? Are we still looking at May?

    Sentiment: Buy

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    • Thanks for the replies.

    • The posts below are pretty insightful and informed. April is a possibility, May seems more likely, but in truth nobody can be truly sure of this as we have so little definitive information.

      • 1 Reply to iago4466
      • Iago, I saw your reply to me on Reds thread about HR. I did not reply because I see no reason to bring that thread back to the top. Your response was well stated and in hind sight, I should have not said anything. I just hope for Reds sake and others, they are taking notes when HR talks about investing strategy and shorting, I know I am. As far as the EMA, I would think a rise in volume would be one sign to look for. If traders think the EMA is in April, I would think they would begin placing bets. If the EMA is in April, are we looking at the 20th time frame? Can you confirm this for me? Thanks

        Sentiment: Buy

    • I have written them for explanation and what I can gather over 2-3 emails is that we are definitely at 180 days. ARNA has responded to the LoOI but we don't know if they have provided an oral response. What is not clear is whether the clock stays stopped while the EMA gets the outside scientific advice. My best guess after reading their emails is that it does stay stopped until the LoOI is completely answered and that would include the request for outside scientific opinion. If not then 210 days could be this April's mtg.

      I have tried but yahoo won't let me post their email. I am waiting for another response specific to the 180 LoOI response, but they take 3-4 weeks to answer.

      Sentiment: Strong Buy

      • 3 Replies to surfer50st
      • Post somewhere else like Ihub

      • We don't know for sure if Arena have provided an oral response below is Craig Audet answer to Lee Kalowski on March 4th. (part transcript)

        Lee Kalowski - Crédit Suisse
        And just as far as where things stand in Europe, can you say, have you gone through an oral hearing? Is that something that is going to happen down the road? Or is that something that’s already happened? And as far as the list of 180-day questions, prior to that, had you given the CHMP essentially all of the same information that you had given FDA as part of their review process?

        Craig Audet - Senior Vice President, Operations and Head, Global Regulatory Affairs
        We have not been to an oral explanation. We have been invited to one, though. But it is still proposed at this time. The day has not been set, and it’s not definite that that will happen or not. So we have to wait until the CHMP has done a little bit more of an assessment, and then they’ll let us know whether they want us to come and speak to them.

        In terms of the 180 day, we have given the CHMP the same information that we’ve given to the FDA, so they have the same information in order to make their determination in terms of safety and efficacy.

        Sentiment: Strong Buy

      • thats the key we dont know if arna has given their oral or even if a date has been set...They cant say one way or the other...If oral was given in march which is a good guess then we will be on this month..At least we have not been rejected like vvus was which is encourageing

    • Forgot to mention that the CHMP opinion must - must - be issued within 30 days after the oral presentation is made.

    • Either April 26 (yes, that is quite possible) or May 31. The big issue is this: Has Arna already made the oral presentation? I have really invested a lot of my time in figuring this one out. I have even had e-mail exchanges with the EMA to clarify issues that have caused confusion.

      Do not focus on the fact that ARNA was "requested" to make an oral presentation. That is standard CHMP terminology. The sponsor always has the option of making the oral presentation or not. If ARNA had turned the request down (btw, no one does that), we probably would already have seen the CHMP opinion, because the clock would have started ticking again in early March.

      I think ARNA presented in the last week of March. Hence April 26 is a possibility. If they did not present at the end of March, then they will at the end of April, which means a May 31 opinion.

1.57-0.04(-2.48%)Feb 5 4:00 PMEST