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What Changed After the 86 Vote A favorable recommendation now sits in the official record The clearest change is procedural: FDA now has a formal recommendation from its advisory committee supporting inclusion

Intensive (500mcg twice daily) = 5 days

Handle under appropriate laboratory conditions

Reconstitution calculations determine how much water to add for desired concentration

Reithmeier showed in 1987 that the structure of another calcium-binding protein, calsequestrin (which binds 40-50 calcium ions and is characterized by high levels of acidic residues), is calcium-sensitive as well, as this protein was rapidly degraded by trypsin in the absence of calcium, but showed remarkable stability in calcium-loaded form (Ohnishi and Reithmeier, 1987)