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Affymax, Inc. Message Board

  • declaes declaes Sep 9, 2013 1:23 PM Flag

    FDA mailed me back...

    I got a very encouraging anwser...

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    • It is very good news all along I've been saying the Same thing "it is just the first day issue".
      They can suggest a precautionary tests for this reaction or a low dosage initial regimen in a hospital sort of settings.

      They can very easily bring this product back to life. Once comes back it will be a Block Buster.


      Sentiment: Strong Buy

    • Declaes Mom just mailed me this back.....She said.. now this is verbatim " I love it from the shorts, I love it from the longs. But I really like it when guys are long" Who do you believe these days? Someone is gonna swallow when it's all said and done.

    • nice... all this death #$%$ could be a conspiracy theory, it allows the BIG boys to get a second go around on BIG money, period! it's a flippen game IMO.


    • care to share?

      • 1 Reply to mfm401kvp
      • "Thank you for writing the Division of Drug Information, in the FDA's Center for Drug Evaluation and Research (CDER). As you may already be aware, in Februrary 2013 Affymax and Takeda announced a nationwide voluntary recall of ALL LOTS of Omontys (peginesatide) injection. This was a result of postmarketing reports regarding serious hypersensitivity reactions, including anaphylaxis, which can be life-threatening or fatal. The companies have been working actively with the U.S. Food and Drug Administration (FDA) which has indicated its agreement with this decision.

        To date, fatal reactions have been reported in approximately 0.02% of patients following the first dose of intravenous administration. The reported serious hypersensitivity reactions have occurred within 30 minutes after such administration of OMONTYS. There have been no reports of such reactions following subsequent dosing, or in patients who have completed their dialysis session. Since launch, more than 25,000 patients have received OMONTYS in the postmarketing setting. The rate of overall hypersensitivity reactions reported is approximately 0.2% with approximately a third of these being serious in nature including anaphylaxis requiring prompt medical intervention and in some cases hospitalization. The companies are actively investigating these cases. For further information, please visit:"

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