Oxigene Neu-Sensamide NDA may reference Sensamide pivotal data, FDA has told company -- CEO.
OXIGENE NEU-SENSAMIDE RADIATION SENSITIZER ON TRACK FOR 1998 NDA filing, Oxigene CEO Bjorn Nordenvall, PhD, indicated during a UBS Securities conference in London April 15. A Phase III trial of the high-dose metoclopramide formulation will be completed by the second quarter of 1998, putting the drug on track for a 1999 launch, Nordenvall estimated. The company plans to use a Phase III trial of an earlier formulation, Sensamide, to support the application. FDA has told the company that data from the two formulations can be included in the Neu-Sensamide NDA, Nordenvall said.
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