Re: AMAG Hits New Low as Makena No Better than Placebo in 1700 Patient Post-Approval Trial; Questions Raised about Study Group Differences
This is probably an overreaction. They will be analyzing the results for months, and then the FDA will be analyzing their analysis for months, before any conclusion is reached. 25% of the trial was in the United States, so I guess they'll be looking very carefully at those patients and how they compare to the 75% from Eastern Europe. In my opinion there is no way that the fate of an approved drug which has been used with apparent satisfaction for a decade will be decided by a single trial conducted mainly in Eastern Europe because of U.S. doctors' refusal to participate in it. AMAG will be presenting on Monday at Cowen, 1:30 p.m. ET.