A complete response letter (CRL) from the FDA delays a product's entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them. Imagine how much you could save if you could anticipate the FDA's concerns and address them before the agency issues the complete response letter? Now you can.
Celgene said its unit Celgene International Sàrl announced results of its Phase III, randomized, international study of ABRAXANE (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in chemotherapy-naïve patients with metastatic melanoma. RTTNews