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Arena Pharmaceuticals, Inc. Message Board

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  • doctorevensen doctorevensen Jun 22, 2012 7:41 PM Flag

    MY IMPRESSION AS WEIGHT LOSS DOCTOR

    Here is the link that will answer all your questions on how to develop your own weight loss drug and have it approved by the FDA (it only takes 3-7 years, and hundreds of millions of dollars)....the "Guidance for Industry: Deveolping Products for Weight Management"

    http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071612.pdf

    see page 7 for efficacy benchmarks....it is very interesting that most people only mention the two benchmarks, below this it states "changes in common weight-related comorbidities should be factored into the efficacy assessment of investigational weight-management products"....thus the positive change in diabetics HgbA1c with this drug is a substantial positive with this drug....just look at how the endocrinologists voted for it!!!

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    • Thanks, that was one of my concerns. I wasn't sure that the diabetes aspect would be considered since weight loss was the end point of the studies. That more, or less has helped me decide that it will be approved. My only remaining concerns are with the DEA classification as a class IV drug. That is somewhat troublesome to me, but I guess it is to be considered since it is a drug that works with mechanisms in the brain. Was Phen/Fen considered a class IV drug? Different receptors, but still would be interesting to know.

      Thanks you have been very helpful during worrisome times.

 
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