There was only one question on the phone call, repeated 25 different ways. Here is a summary of what I heard from the CEO:
1) 483 is separate from the approvable letter 2) Issues from the 483 were comprehensively responded to in AMAGs response to the FDA 3) AMAG IS ONLY WAITING FOR THE FDA TO RESPOND TO THE MANUFACTURING ISSUE RESONSE - THIS IS THE RATE LIMITING STEP 4) It sounds like the label has been negotiated and is awaiting agency sign-off 5) The CMC technical response can be readily, quickly, and effectively addressed. 6) The label is not currently split and the target population is ALL chronic kidney disease patients. From predialysis to dialysis.
Bottom line: It looks like AMAG has a shot at NOT having a new PDUFA date issued. They may just receive an approval from the FDA following the resolution of the manufacturing issues.
Good summary. Good news seems that approval is a done deal with the maufacturing caveat. But bottom line is, there still will be a delay however small. With the Holidays right around the corner, not much will happen for the next 2 weeks. So we are looking at least 1 month and a half to 2.