Why is FDA biased?
Is 3% weight loss SIGNIFICANT? Qnexa vs Phentermine math
"PHEN/TPM achieved significantly greater weight loss compared to its components"
Now check slide 6 from FDAs presentation
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM227050.pdf
Mid dose(7.5/46 mg)
LS Mean % loss for Qnexa - 8.5
LS Mean % loss for Phentermine - 5.5
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LS Mean % loss difference - 3.0
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High dose (15/92 mg)
LS Mean % loss for Qnexa - 9.2
LS Mean % loss for Phentermine - 6.1
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LS Mean % loss difference - 3.1
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Do your math for Topiramate and now answer, do you get the picture?
Lorqess a novel compound has 3.8% mean adjusted weight loss compared to placebo arm with clean safety profile.
How can FDA not see this? If they do see, why are they biased? Is 3% considered SIGNIFICANT or "SLIM MARGIN"?
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