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Theres no revenue share, no equity stake, and no long-term contracts to worry about

We are not aware of any way for a 503B to demand that the FDA inspect them, so the timing of an inspection is not entirely in an outsourcing facilitys control

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Clinical trials did not specify a relationship to meals, and absorption occurs through subcutaneous tissue, not the GI tract, so food in your stomach has no direct effect on how the drug enters your bloodstream

Outcomes included restored walking indices, reversal of contracture, preservation of muscle mass, and complete structural reattachment confirmed by imaging