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We further proposed that if a manufacturer submits a complete and timely extension request, and CMS determines that the information submitted warrants an extension of the rebate reduction, the total rebate amount would be reduced by 75 percent for a second consecutive applicable period for that manufacturer's generic Part D rebatable drug in accordance with 428.303(b)(2)

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Unlike RAD-140, it has been through Phase II and III human clinical trials, giving it one of the most documented safety and efficacy profiles among SARMs