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Arena Pharmaceuticals, Inc. Message Board

  • tiger_josef tiger_josef Mar 1, 2013 5:42 PM Flag

    EMA Time analysis based on the 10-K filed on 03/01/2013 4:15 PM (ET)

    ================
    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.
    ================

    Looking at the CHMP Timetables, there are two timetables of interest.

    EMA Timetable on Page 8
    Timetable 3: Responses to List of Outstanding Issues - LoOI (30-day Assessment after clock-stop for responses to issues) – 3rd phase

    1) February 18, 2013 with a corresponding CHMP Opinion on March 21, 2013 [Possible also see 3) below Timetable 4 analysis below from Page 11]
    2) March 25, 2013 with a corresponding CHMP Opinion on April 25, 2013 (Unlikely IMO, since the total number of days will be over 210 days)

    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

    3) February 27, 2013 with a corresponding CHMP Opinion on March 21, 2013 (Possible)

    From the above 3 Scenarios whether ARNA responded on or before February 27 in either 1) or 3) above the CHMP Opinion seem to conclude on March 21, 2013 unless a Second LoOI is issued on March 21, 2013.

    Only if ARNA submitted on February 28, 2013 might mean that they missed the February 27, 2013 Deadline which could push the Final Opinion OR a Second LoOI to April 25, 2013.

    Sentiment: Strong Buy

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    • I’m amazed each one of us who posted what is basically public information got two thumbs down what a strange world we live in.

      Sentiment: Strong Buy

    • just a note to thank you all for an informative and meaningful thread. My word this board had been hijacked and this is a breath of fresh air. kudos

    • One example of Previous Drug, if you like to check other drugs too then Search for "Steps taken for the assessment of the product" with quote unquote and add the word CHMP or EMEA

      From Assessment Report For Yervoy dated May 19, 2011
      ===================
      • During the CHMP meeting on 17 March 2011, the CHMP agreed on a list of outstanding issues to be addressed in writing and/or in an oral explanation by the applicant.
      • The applicant submitted the responses to the CHMP List of Outstanding Issues on 18 April 2011.
      • The Rapporteurs circulated the Joint Assessment Report on the applicant’s responses to the List of Questions to all CHMP members on 4 May 2011.
      • During the meeting of May 2011, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, issued a positive opinion for granting a Marketing Authorisation to Yervoy on 19 May 2011. The applicant provided the letter of undertaking on the follow-up measures to be fulfilled post-authorisation on 19 May 2011.
      =================
      Just to note that the above example had a List of Outstanding Issues and required and Oral Explanation; yet between the response to the LoOI and the Final Opinion there is only 30 Days. Did the OE occur during the May 2011 meeting and CHMP concluded the Final Opinion at the end of the same meeting. I think so....

      Anyways, I think March or April are both plausible, IMO

      Sentiment: Strong Buy

    • TJ - I have read the these timetables but the timing depends on when the clock restarts - here is message I posted on IVB:

      "The clock won't restart until after the oral explanation. Although the wording does say invited by the CHMP, but I would assume that Arena will present an OE. As far as timing it will depend on when the consultation takes place with the outside experts for their recommendations. My guess is that the OE could now take place on the April CHMP docket but if consultation is completed then this month is a possibility.

      "If the Marketing Authorisation Holder/Applicant has to prepare not only written responses but also oral explanations (OE), the procedure will restart according to the next restart date following this OE.""

      Therefore, it is my opinion based on the above (which is a note below the timetable - (LoQI (30 day assessment.......) - 3rd phase.); that it could fall into the April date with an opinion in May. Assuming OE is done, day 181 is the first day of the OE meeting. Now it is possible that March 25, 2013 date above is the date of the OE. The key is when the independent experts have completed their work. Now that consultation work by the independent experts imo could almost be completed, at least let's hope that is the case.

      Sentiment: Strong Buy

      • 3 Replies to jdsstevens55
      • Jim,

        On second thought after my last response post. Is there a chance that the Oral Explanation and the Final Opinion be cramped in the same CHMP meeting of March 18 thru March 21, I doubt it, still possible.... I'm going to look more into this by reading the CHMP Final Assessment Reports on other drugs.

        Sentiment: Strong Buy

      • Jim,

        You indicated ""If the Marketing Authorisation Holder/Applicant has to prepare not only written responses but also oral explanations (OE), the procedure will restart according to the next restart date following this OE."""

        yes, that was a footnote on Page 9 that I inadvertently neglected to read; so thanks... however, I just like to note the differences between Phase 3 Timetable on Page 8 and Phase 3 Timetable on Page 11

        Page 8 Timetable by definition = LoOI (30-day Assessment after clock-stop for responses to issues)
        Page 11 Timetable by definition = LoOI (30-day Assessment after immediate responses to issues or Oral Explanation)

        Differences even though both Timetable are for Phase 3:
        1) The footnote (*) on Page 9 for the Timetable on Page 8 does not repeat on Page 12 for the Timetable on Page 11.
        2) Page 11 in the definition includes the words "or Oral Explanation" compared to Page 8 which has the reference footnote.
        3) Although the Opinion Dates in both Timetables are the same, the Submission Date is more relaxed in the Timetable Page 11 by 1 Day up to 10 Days compared to Page 11 (Example Page 8 has February 18, 2013 for the submission and Page 11 has February 27, 2013 as the submission date even though both has the same Opinion Date of March 21, 2013)

        Therefore, I suggest using the Timetable on Page 11, here is why:
        1) Assuming that the Oral Explanation happens at the next CHMP meeting (** See below) during the week March 18 thru March 21, 2013; from there we can go one line down on the Same Page.
        2) Submission Date after Oral Explanation of March 27, 2013 leading to a Final Opinion OR Second LoOI on April 25, 2013

        (**) If my memory serves me right, I have read other drugs CHMP Assessment reports that indicated the Oral Explanation did happen during the CHMP regularly scheduled monthly meetings.

        Conclusion: To me April 25, 2013 seems to be right after reading everything put together which would lead to either a Final Opinion OR a SECOND LoOI

        Sentiment: Strong Buy

      • JD from

        JD from their K10
        European Union
        In March 2012, we submitted a Marketing Authorization Application, or MAA, through the centralized procedure with the European Medicines Agency, or EMA, for the marketing approval of BELVIQ in the European Union. The proposed indication for BELVIQ in the European Union is for patients over 18 years old as an adjunct to diet and exercise for weight control in obese patients (BMI ³ 30 kg/m2), or overweight patients (BMI 27 kg/m2) with associated risk factor(s), such as hypertension, dyslipidemia, type 2 diabetes managed with oral hypoglycemic medicinal products, or sleep apnea. For our centralized submission, the United Kingdom has been assigned as rapporteur and Sweden as co-rapporteur.
        The EMA’s Committee for Medicinal Products for Human Use, or CHMP, provided feedback to our MAA in the form of a Day 120 List of Questions. We responded to the CHMP in October 2012, and, in January 2013, the CHMP provided further feedback in the form of a Day 180 List of Outstanding Issues.
        The major objections in the Day 180 List of Outstanding Issues relate to non-clinical and clinical issues, including tumors in rats, valvulopathy and psychiatric events, and the CHMP requested that we further justify BELVIQ’s overall benefit-risk balance taking these issues into consideration. The issues will need to be addressed before the CHMP can recommend BELVIQ for marketing approval in the European Union.
        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

        Sentiment: Strong Buy

    • Thanks Tiger for the very good detailed post! Definately now looks like Mar EMA Approval instead of Apr or May, thus the rapidly rising OI (Option Open Interest) in ARNA Calls and lowering P/C Ratio (trading in Puts vs Calls ratio).

      In summary, ARNA pps should move up dramatically from March 4th on.

      Sentiment: Strong Buy

    • Yahoo didn’t like my comments and blocked them. Here goes I’ll try again.
      CHMP has received a Risk Management Plan (RMP) from PARC on lorcaserin. RMP comes with conditions in my opinion but still looks good on approval.

      Sentiment: Strong Buy

    • 7 February 2013
      EMA/91065/2013
      Pharmacovigilance Risk Assessment Committee (PRAC)
      Pharmacovigilance Risk Assessment Committee (PRAC)
      Minutes of the meeting – 7-10 January 2013

      Risk Management Plans (RMPs)
      (Item 5 of the PRAC Minutes)
      The RMP describes what is known and not known about the safety of a medicine and states how the side effects will be prevented or minimised in patients. It also includes plans for studies and other activities to gain more knowledge about the safety of the medicine and risk factors for developing side effects.

      5. Risk management plans ........................................................................16
      5.1. Medicines in the pre-authorisation phase............................................16
      5.1.1. Afatinib (dimaleate) ........................................................................17
      5.1.2. Atosiban........................................................................................17
      5.1.3. Avanafil.........................................................................................17
      5.1.4. Bedaquiline...................................................................................17
      5.1.5. Fenofibrate / simvastatin................................................................17
      5.1.6. Infliximab....................................................................................17
      5.1.7. Infliximab.....................................................................................17
      5.1.8. Lorcaserin Hydrochloride ............................................................17
      5.1.9. Masitinib mesylate.......................................................................17
      5.1.10. Memantine hydrochloride...........................................................17
      5.1.11. Ponatinib ......................................................................................17
      5.1.12. Regorafenib .................................................................................17

      I’ve been researching the EMA w

      Sentiment: Strong Buy

      • 2 Replies to danfinn61
      • The PRAC minutes don't include discussions of RMP's for pre-authorized meds until after the CHMP opinion is issued.

      • dan: I have seen this but there is no detail on the RMP. BTW, the RMP is developed by Arena and submitted either with MAA or after MAA. In fact, the new edict from EMA requires all MAA submissions after July XX, 2012 to have an RMP submitted with the MAA. As we know Arena submitted MAA in March 2, 2012. If RMP not submitted at that time, it probably was required as part of the 120 day LoQI response. Just my guess on that. The inclusion in this document based on research and understanding is that the PRAC is fine with Lorcaserin RMP.

        My other guess based again on research on the EMA is that Arena has to (maybe already done so) submit what is called a "Incident Management Plan" which would describe how the Sponsor (Arena) plans on tracking certain incidents (in lorcaserin's case, incidences of valvulopathy and certain pysch events). Essentially it is setting up a registry. My guess is that Arena finalized their plan with their 180-day written response back to the CHMP.

        Not a slam dunk imo but moving forward in the right direction towards EU approval. Think about it, did the CHMP bring in independent experts for Q? The answer is no. If the CHMP was leaning toward rejecting Belviq, why go that extra step?

    • Bringing this back to the top as per request.

 
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