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The federal agency wants to see records showing how a select group of willing patients responded to receiving a drug versus a placebo to confirm that its safe for patients with specific conditions to take it
EMA, Ozempic
One arithmetic point is specific to this size, where a proportional error is easy to overlook
To get a drug FDA approved, a company must conduct phase 1, 2 and 3 clinical trials proving safety and efficacy of the compound through a laborious, multi year and extremely costly process
Weight loss 5% is generally considered to be clinically meaningful [10]
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