FDA questions credibility of Daiichi data ahead of AdComm

FDA questions credibility of Daiichi data ahead of AdComm

Source: 
Fierce Biotech
snippet: 

The FDA has questioned the reliability of the phase 3 results Daiichi Sankyo hopes will win it approval for quizartinib in acute myeloid leukemia. Officials raised the concerns in a briefing document to support an upcoming advisory committee meeting.