Delcath Systems Inc.’s decision to overhaul the ongoing Phase III study for its melphalan chemosaturation system could get the company closer to resubmitting a new drug application in 2019 but also brings with it considerable regulatory risk.
The company announced July 27 that it is reducing by two-thirds the size of the FOCUS trial in patients with ocular melanoma that has spread to the liver, altering the design from a
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