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there's no federal mandate for batch-level potency, sterility, or endotoxin testing Limited batch size: Generally produce smaller quantities for individual patients No FDA inspections: Not subject to routine FDA inspections (though the FDA can inspect in response to reported problems) 503B Outsourcing Facilities Section 503B outsourcing facilities represent a higher regulatory standard for compounding operations

Beyond the pipeline, investors should examine whether the company has demonstrated disciplined capital allocation reinvesting cliff-period cash flows into acquisitions or internal development rather than returning all capital to shareholders in a manner that leaves the company underinvested in its post-cliff portfolio

A $10 biotin supplement does the same thing a $40 gummy does

STEP 4 patients lost 10.6% by week 20