Spectrum Pharmaceuticals Inc.’s (SPPI) New Drug Application for EOquin as intravesical treatment for patients with non-muscle invasive bladder cancer is slated for review by an outside panel of experts on September 14, 2016.Intravesical treatment refers to administering the drugs directly into the bladder through a catheter.The FDA’s final decision is scheduled for December 11, 2016. The regulatory agency usually follows the recommendations of its panels although it is not mandatory.Spectrum, in 2008, had entered into a $345 million licensing deal with Allergan Inc. (AGN) to develop EOquin. In 2012, two of the phase III trials of EOquin in patients with non-muscle invasive bladder tumors failed to meet their main goal. The following year, i.e. in January 2013, Allergan returned the rights to develop EOquin to Spectrum. Although the two trials failed, pooled data from the two studies showed a statistically significant treatment effect for the primary study endpoint, i.e., a reduction in the 2-Year Recurrence Rate, in favor of EOquin, and in a key secondary endpoint, namely, Time to Recurrence.Spectrum conducted another phase III trial of EOquin in October 2015, satisfying FDA's requirement of an additional phase III study before NDA submission.It remains to be seen whether EOquin, which has had its share of initial setbacks and negative clinical trial results, will clear the penultimate regulatory hurdle in the U.S. when the FDA panel members cast their vote on the issues related to its approvability.