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A Phase 2 trial (NCT01311518) was designed to test RGN-352 in ~75 heart attack patients, but was placed on FDA clinical hold in 2011 due to manufacturing (GMP) compliance issues at the contract site not safety concerns with the drug itself

KPV is derived from alpha-MSH but does not bind melanocortin receptors (MC1R, MC3R, MC5R)

Per the applicant, the VersaVue TM Single-Use Flexible Cystoscope is (1) not considered equipment, an instrument, apparatus, implement, or item of this type for which depreciation and financing expenses are recovered as depreciable assets, and is (2) not a material or supply furnished incident to a service, and, therefore, is eligible to be considered for pass-through payment

Duration: Preclinical studies have lasted about 4 weeks on average

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The reconstitution process is identical, but there are important differences