Spectrum Pharma (SPPI) Receives FDA Complete Response Letter Related to QAPZOLA NDA

November 18, 2016 6:05 AM EST

Get daily under-the-radar research with StreetInsider.com's Stealth Growth Insider Get your 2-Wk Free Trial here.

Spectrum Pharma (NASDAQ: SPPI) disclosed the following in a U.S. SEC filing on Friday:

Item 8.01 - Other Events.

On November 17, 2016, Spectrum Pharmaceuticals, Inc. (the “Company”) received a Complete Response Letter from the U.S. Food and Drug Administration (the “FDA”) with respect to the Company’s New Drug Application for QAPZOLA (apaziquone for intravesical instillation). On November 15, 2016, the Company met with the FDA to discuss the strategy for further development of QAPZOLA. Based on the discussions, the Company is evaluating a new smaller study that would replace the ongoing Phase 3 program in which enrollment has been stopped.

Serious News for Serious Traders! Try StreetInsider.com Premium Free!

You May Also Be Interested In

Related Categories

Corporate News, FDA, Hot Corp. News, Trader Talk

Add Your Comment