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Arena Pharmaceuticals, Inc. Message Board

  • tiger_josef tiger_josef Feb 15, 2013 6:23 PM Flag

    Honest and True Conversation with my Endocrinologist

    I just got home from appointment with my Diabetes Specialist and here is what transpired during my appointment. We had about a fifteen minute conversation concerning my weight and how I would like to use BELVIQ to bring the weight down.
    Some History: During last meeting with his practitioner helper (a lady) about 4 months ago my HbA1c (3 months average) measured 6.8% and that was mainly attributed to me taking Glumetza 2000mg daily that caused my stomach to act up. So I asked to reduce down to 1000mg daily and that worked well for me in the last 4 months.
    Synopsis of today’s appointment:
    My HbA1c today measured 7.2% and the Cholesterol was 230. That’s when we started discussing BELVIQ. I gave him all the information I know to date about BELVIQ and he promised me to Look into the BLOOM; BLOSSOM; BLOOM-DM trial results and hopefully on my next appointment (3 months from now) he will prescribe BELVIQ for me.
    I asked “Are you aware that Qsymia is currently available?”
    The first reaction I got is a shrug in the face and he started mentioning about the stems of the problem going back to f e n / f e n
    I asked “Will he be able to subscribe BELVIQ with F e n if needed?”
    His response was that he currently has some of his patients on F e n on a need to basis and yes he can prescribe with BELVIQ if he feels there is a need for it.
    =====================
    Jairy,
    My earlier response concerning the 45 day DEA review period did not post, I did say that I will not retype and repost the response because I was on my way out to this appointment.
    Here it is again:
    Your last response:
    “The few examples shown indicate the average time for DEA to issue the final order after close of the comment period is from 30-45 days. In the instance of Nucynta it was 63 days. If you look at the 2 flow charts under the "FDLI Annual Conference" section you will note the timeframe is 30-60 days.

    This leads me to conclude that there is no guideline limiting the DEA to 45 days in which to issue a final order. FDLI is not a government agency.”
    Here is my response:
    Nucynta took 63 days because it got interrupted during the comment review period, see page 6 of the report "Industry Perspective on Scheduling Process"
    DEA Prop Rule - Schedule II on 17-Feb-09
    NPRM on 20-Feb-2009
    End of Comment Period 20-March-09
    FDA Grants Waiver for PAS on 29-Apr-09 = 40 Days during the Comment Review Period.
    DEA Final Rule - Schedule II on 22-May-09 = 23 Days Later for a total of 63 Days
    Authorized to Market on 22-Jun-09
    Concerning the 30-60 Day Flowchart is the estimated range by FDLI however everything that has been reviewed by the DEA post the 2006 ruling took between 30 and 45 days most notably the drugs on page 3 that had between 38 and 43 days for the comment review period.
    Yes, FDLI is not a government agency rather FDLI is a research consulting non-profit agency that deals with FDA and DEA scheduling processes. I looked for regulations on this issue and could not find any, good luck to you finding a reference in the Justice Department that cites a certain limited day requirement. All what has been mentioned so far is based on actual time experience for existing drugs on the market.

    Sentiment: Buy

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