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MH received clinical trial materials and funding from Janssen Pharmaceutica NV for work related to this trial

Bottom line: even if the FDA eventually recommends that certain peptides can be compounded under Section 503A, many stakeholders could still be blocked by the requirement to source pharmaceutical-grade API from an FDA-registered establishment with a Certificate of Analysis and by FDAs demonstrated willingness to police marketing claims around compounded drugs

Over six months, this approach results in an average weight loss of 810%, equivalent to 810 kg for most patients

In some embodiments, the otic formulation or composition comprises between about 0.01% to about 30% by weight of the therapeutic agent, or pharmaceutically acceptable prodrug or salt thereof