Marqibo received an accelerated approval for adults with Philadelphia chromosome (Ph) negative acute lymphoblastic leukemia (ALL) in second or greater relapse or that has progressed following two or more prior lines of anti-leukemia therapy on august 9, 2012.
Here it is close to one year later and the product has not been launched. Isn't there a time limit that FDA would put on how long a company can wait to launch a new drug after receiving an accelerated approval?