CTICD Cell Therapeutics-FDA set early June pixantrone meeting
Puget Sound Business Journal
Date: Friday, May 20, 2011, 9:52am PDT
Related:Health Care
Officials with Cell Therapeutics Inc. said they’ll meet with representatives from the U.S. Food and Drug Administration’s Office of Oncology Products early next month to discuss resubmitting the company’s pixantrone cancer drug application.
Officials with Cell Therapeutics Inc. said they’ll meet with representatives from the U.S. Food and Drug Administration’s Office of Oncology Products early next month to discuss resubmitting the company’s pixantrone cancer drug application.
Earlier this month, the FDA’s Office of New Drugs “denied the dispute appeal request to conclude that the efficacy of pixantrone has been demonstrated,” but Cell Therapeutics added the “accelerated approval of pixantrone NDA 022481 may not necessarily be out of reach based on a single controlled clinical trial, provided two key matters can be satisfactorily resolved. ... If these two key matters are addressed satisfactorily, then PIX301 could be deemed successful,” officials said in a statement.
Cell Therapeutics said it will submit a review of a research panel and additional information to the FDA.
Earlier this week, in an effort to get its stock price above the NASDAQ stock exchange’s $1-per-share minimum, Cell Therapeutics (NASDAQ: CTICD) enacted a reverse six-for-one stock split. Its shares now trade above $1 for the first time in 14 months.
