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The interest of clinicians in developing their own data on Celgene Corp.'s Thalomid thalidomide to treat multiple myeloma has enabled the company to submit an sNDA before its own Phase III data are in hand.

In 2002, the company had planned to submit an sNDA after running four trials of Thalomid in MM patients, but without a Phase III study. "After discussions with FDA, we decided that it would not be in our best interest," CEO John Jackson told BioCentury. "In those discussions, the agency suggested that we should initiate a trial in newly diagnosed multiple myeloma patients."...