On Monday, the FDA posted a substantially negative assessment of pixantrone in advance of Wednesday's FDA advisory panel meeting. The FDA review hits on almost all seven of the pixantrone concerns and problems I raised.
|Cell Therapeutics' CEO Jim Bianco|
- The randomized study was stopped at less than 50% of its planned accrual because of poor accrual. Do the efficacy data support accelerated approval of pixantrone for the proposed indication?
- Is the risk:benefit ratio favorable for the proposed indication?