With most recent Salmonella/peanut butter manufacturing debacle added to the long list of examples of FDA negligence and incompetence under previous administration and new reports of manufacturing issue concerns, it looks to me as though any approval now is a very long shot.
I believe the new FDA commissioner will first totally revamp and upgrade FDA quality, scrutiny, processes and controls. Especially w/ a manufacturing issue, don't think he/she will allow Ferumoxytol approval until entire new inspection process completed. I not only sold most of AMAG position, I now am shorting.
disagree with that ,your not comparing apples to apples ... amag could get approval tonight ,or anyday...only people who know of the problems are the fda and amag , although problems could be major or they can be minor..