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Even if the PCAC votes in favor and the FDA agrees, formal notice-and-comment rulemaking is STILL required, a process that can take a year or more under standard timelines

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Standard maintenance therapy typically involves hydroxocobalamin 1mg injections every two to three months for patients without neurological involvement

Elevation of intracellular Ca 2+ activates scramblase to ensure PS externalization, opens the Gardos channels, resulting in K + efflux and subsequent cell shrinkage, and mobilizes calpain, leading to cytoskeleton degradation and membrane microvesiculation [78]