Onconase maker meets with FDA concerning mesothelioma drug
Mesothelioma, Onconase and the FDA
Alfacell Coporation, the maker of Onconase, a drug for the treatment of mesothelioma, met with the FDA to discuss the company’s submission of the final parts of the Onconase New Drug Application (NDA).
At the pre-NDA meeting, the FDA gave some guidance to the company by recommending that an additional clinical trial be conducted in patients with malignant mesothelioma who have failed a prior chemotherapy regimen.
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NY mesothelioma lawyers: Onconase manufacturer meeting with FDA