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Arena Pharmaceuticals, Inc. Message Board

  • eccentricattorney1970 eccentricattorney1970 Mar 23, 2013 7:55 PM Flag

    CHMP and Europe

    Does anyone know if the timeline has restarted. I believe it has but others don't think so. If and when it started we will then be able to count down days from then till a decision. Any intelligent input is welcome.

    David

    Sentiment: Strong Buy

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    • Response to R& G post

      R&G Stated " As has been pointed out, we know with certainty that we are at least at day 180. The clock restarts when Arena makes its oral presentation, which I believe happened on the 20th or 21st of March."

      R&G

      If you think the OE happened March 18th or 20th, and without a final opinion on the 21st would take us to the EMA Timetable on page 11

      Timetable 4: Responses to List of Outstanding Issues - LoOI (30-day Assessment after immediate responses to issues or Oral Explanation) – 3rd phase

      Scenario 1:
      30-day Assessment after immediate responses to issues: There could be still minor issues that the EMA might request a quick response on thru a 2nd LoOI with a Deadline Submission date of March 27, 2013 (4th line down on the table). This would yield a Final Opinion on April 25, 2013

      Scenario 2:
      The Oral Explanation that you mentioned : The EMA probably needs some time to discuss internally and this will also put the final opinion April 25, 2013.

      Bottom Line and IMO if you are sure that the OE did occur on March 18th or 20th, then April 25, 2013 has to be the Final EMA Opinion.

      Sentiment: Strong Buy

      • 1 Reply to tiger_josef
      • Tiger, thank you for the post. I am not sure what to believe at this point. Just out of curiosity, do you see E.U. approval as a likely event? I see that some believe the likely hood is over 80% and as high as 93% based on previous cases dealing with outstanding issues. Where I become a little skeptical of approval is from the huge difference in healthcare systems and the culture of the E.U. vs the U.S. I honestly am not sure of what percentage I would put on an approval at this point. Another issue I see some debating is whether or not a flat out rejection is currently priced in too the PPS. I would most certainly think not and that low 6s and 7s might become the new range until sales numbers would begin flowing in. Any thoughts on this? I saw an earlier post from you stating that you want to avoid talking strategy so if you are not comfortable sharing any ideas/thoughts, no prob. Thanks in advance.

        Sentiment: Hold

    • based on past decisions of companies handed LoOI, the chmp made a decision within 3 to 4 months. Arna was handed at LoOI in January, which puts right at an April or May decision. either way it fits within the 1st half of 2013, so fasten your seat belts.

    • If Arena presented last week (I am pretty confident they did), then two days later the clock restarted at Day 181 and will run non-stop to Day 210. Under the rules, Arena was to have its oral presentation scheduled within 30 days after submitting the written responses (which were submitted in February), unless Arena asked for more time. However, I see no reason for Arena to submit the responses in February and then ask for more time to make an oral presentation.

      Consequently I believe the clock will hit Day 210 on April 22. Of course, the CHMP does not have to wait for Day 210, they can issue the opinion sooner.

    • JDSTEVENS hit right on the head...We just dont know when the experts will be finished or if there is oe required......ONE thing for sure is that in the looi there was NO questions about efficacy, Lorc meets the standard...Looi contained safety concerns , rat cancer cv related problems...Answered already to the fda and they approved and at least we got an looi and not just an rejection like VVUS...Our odds are good at this point. I think we will get approval with POST cv studies being done just like here

    • Thats the problem - no one knows. There are no experts on the number of days we sit at, at present. Could be 175 could be 160, could be 205, no one knows and ARNA isn't saying and EMA ain't saying.

      Kind of weird, huh?

      They want to hold themselves accountable to a timeline, but they can put a number up and say this is the day # we have.

      Fed up with USA and EU. I'm going to move to Brazil.... Venezuela... or maybe Cuba. At least there, you know the govt. is going to make stuff up to #$%$ over, and you don't worry about it.

      • 3 Replies to chrisanja
      • As has been pointed out, we know with certainty that we are at least at day 180. The clock restarts when Arena makes its oral presentation, which I believe happened on the 20th or 21st of March.

      • Is it possible we are counting down from the 180 already. It is a shame that they do not share these timelines with the share holders. I was hoping that we would have an answer in April.

      • Chisanja: We absolutely we know we are at Day 180! No dispute on that at all.

        "We have responded to the Day 180 List of Outstanding Issues in writing. As part of this process, the CHMP will consult with groups of independent experts who will provide recommendations on the outstanding issues. In addition, we have been invited by the CHMP to provide an oral explanation, and we expect to have other discussions with the CHMP and their experts. The CHMP is expected to reach its final opinion on the BELVIQ MAA by nominal Day 210, which, accounting for expected clock stoppages during the regulatory process, we expect to occur in the first half of 2013."

        Again, restarting of the clock to day 181 depends on whether or not Arena has to do an oral explantation. Per the March 4th CC, it was stated that a OE may not be required. Arena may or may not have received a notification from the CHMP on whether they have to do an OE. If not, the clock could have restarted. It certainly did not restart after their response above since that restart date would have been either Feb. 19th or Feb. 28th; both with an opinion on March 21st.

        But let's be clear, we are definitely at day 180.

        Sentiment: Strong Buy

 
ARNA
4.16-0.11(-2.58%)Sep 19 4:00 PMEDT

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