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AMAG Pharmaceuticals, Inc. Message Board

  • doublestat doublestat May 12, 2009 1:28 PM Flag

    All is not as it seems...

    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.

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AMAG
26.53-0.06(-0.23%)Jul 29 4:00 PMEDT