I would not be holding AMAG at these levels. The company has not disclosed the next steps in the regulatory process, which either means that they do not know for sure (unlikely), or they are still in debate with the Agency about pivotal issue(s). The clinical review will need to be restarted for the company to be able to discuss a label with the Agency, and it has not been disclosed what it will take to start the clock. It is possible that they have even attempted to re-start the review clock, but been told by the Agency that they need more data to start another cycle, which should have been disclosed if it were the case. However, the decision to stop marketing Feridex was not disclosed, suggesting that transparency is not a hallmark of this management team. I have never seen this level of non-disclosure as a good sign, and think that there is risk that the planned general IDA trials may be necessary PRIOR TO ANY APPROVAL. It is naive to assume that the review process is over and all that is left is to dot the i's and cross the t's. I would cash out on the hype as risk/reward is not favorable at these levels. Full disclosure: I have no vested interest in AMAG, but know the story very well. I would be very careful at these levels and weigh the potential upside versus the downside. The Street is pricing in over a 75% chance of approval, which I think is very, very optimistic.
They will not have a final label until the very end of the clinical review and they need the review clock to be ticking to enter any discussions with the FDA. I view the announcement that the FDA has accepted the resubmission as a minor positive. We will see whether they have enough data to support a viable label in dialysis, which requires frequent administration of iron to meet KDOQI Guidelines. I would sell on any strength from this announcement, as there is very likely much more to this story than meets the eye. We'll see where things head from here.
Since you are in the medical field, perhaps you should contribute your informed opinions about the technology, FDA process, etc and leave the buy/sell decision making to those who have a vested interest in the stock. No one should be giving buy/sell advice to others.
Why would the clinical review need to be restarted? They already have a draft label. If the clinical review really needed to be restarted, wouldn't they get a new PDUFA date? AMAG would disclose that type of information.