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The FDA, EMA or other comparable foreign regulatory authorities can delay, limit or deny approval of a product candidate for many reasons, including: 42 With respect to foreign markets, approval procedures vary among countries and, in addition to the foregoing risks, may involve additional product testing, administrative review periods and agreements with pricing authorities

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Furthermore, SGLT2 inhibitors promote the utilization of ketone bodies as the energy source for the myocardium, which can lead to reduced reactive oxygen species (ROS) production

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