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Affymax, Inc. (AFFY) Message Board

  • godwinpeak godwinpeak Jun 28, 2013 8:55 AM Flag

    Takeda Withdraws O from EMA

    On 28 June 2013, Takeda Global Research and Development Centre (Europe) officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Omontys, for the treatment of symptomatic anaemia associated with chronic kidney disease in adult patients undergoing dialysis.

    PS Somehow Longs will try to spin this as bullish news. A big nail in the O coffin.

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    • Gadflypeckerhead you are a true idiot to say the least! It is a logical step by Takeda to delay the Application Process until conclusion of the Omontys investigation, to not do so would be pure folly! No one here expected a EU Approval during the Investigation. Something for shorts to ponder is this, if there is a new Partner in the wings or a Merger then it makes sense to withdraw the Application now and then resubmit the Application with their names on it, otherwise the process would need to be duplicated wasting time and money. SMART MOVE BY TAKEDA..THEY ARE PRO'S!!!

    • Again you copy and pasted only the part which serves your purpose:

      Here is the remaining letter ...

      This withdrawal is based on the following reason: post-marketing reports of serious hypersensitivity reactions, including anaphylaxis, some of which were life-threatening or fatal, following administration of Omontys in the United States of America (USA), while the EU MAA was under review. Such severe reactions had not been observed during clinical trials. An investigation into the root cause of the reactions was initiated and is currently ongoing. Takeda has determined that it will not be able to complete the investigation and propose appropriate risk mitigation measures within the MAA procedure timeframe.
      There is one ongoing clinical study in CKD patients with pure red cell aplasia. Given that most of the reported serious hypersensitivity reactions occurred after first administration, recruitment of new subjects has been halted. Subjects already in the study have been on treatment between approximately 1 and up to 7 years and have the option to continue receiving Omontys.

      We reserve the right to make further submissions at a future date in this or other therapeutic indication(s).

      There is nothing new in the withdrawal !!!

    • Exactly what was the entire contents of the letter. You may want to reread.

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