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We agree with the applicant that SUL-DUR meets the cost criterion and are therefore proposing to approve SUL-DUR for new technology add-on payments for FY 2024 for the treatment of HABP/VABP and bloodstream infections due to Acinetobacter baumannii, subject to the technology receiving FDA marketing authorization for the indication corresponding to the QIDP designation by July 1, 2023

L -carnitine (LC), a trimethylated amino acid, roughly similar to choline in structure, is a cofactor required for the transformation of free long-chain fatty acids into acylcarnitines and for their subsequent transport into the mitochondrial matrix, where they undergo -oxidation for cellular energy production 19, 20

The results were significant: At 48 weeks, participants receiving the 12 mg dose achieved a mean weight reduction of 24.2% (approximately 58 pounds or 26.2 kg) 100% of participants on the 8 mg or 12 mg doses lost at least 5% of their body weight More than 90% of participants on the 12 mg dose lost at least 10% of their body weight Nearly half of participants on the highest dose lost 25% or more of their body weight The study also showed improvements in cardiometabolic markers including blood pressure, triglycerides, LDL cholesterol, and fasting glucose

& Ley, S