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Affymax, Inc. (AFFY) Message Board

  • foggiafc foggiafc Jun 30, 2013 9:44 PM Flag

    Interesting read on O application withdrawal

    What was the recommendation o
    f the CHMP at that time?
    B
    ased on the review of the data
    and the compan
    y’s response
    s
    to the CHMP lists
    of questions, at the
    time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that
    Omontys
    could not have been approved.
    In
    particular, the CHMP was concerned
    by
    some
    supportive
    study
    results indicating that Omontys
    may
    increase the
    risk of death
    or
    heart and circulatory problems
    in
    patients treated for the first time
    compared with
    similar
    medicines for stimulating red blood ce
    ll
    production. The Committee was also concerned by
    the results of inspections
    indicating
    that the study
    data submitted
    might
    not be
    fully
    reliable.
    In addition, the CHMP was concerned by reports of serious
    hypers
    ensitivity (allergic) reactions, including f
    atal reactions,
    in
    some
    patients
    given
    Omontys
    in the
    United States,
    which
    had
    led to the removal of Omontys from the
    US
    market in February 2013
    .
    Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of
    Omontys
    did
    not out
    weigh its risks.

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    • Its funny no one has pointed out that the chmp does not have the final say and just makes suggestions to the EMA, and for themost part 2/3 of drugs get negative ratings but 1/3 make it through despire that.

    • If O is causing the issue unsure when the Trial is still ongoing for the other indications and that too 7th year in a Row.

      Secondly it is all about First day Allergic reactions. Obviously they need to conduct some initial tests for the new patients to ensure they are OK with Omontys. Every drug causes reactions and my father-in law had a blood thinner administered made by Baxter (I don't remember that name) and he had near death reaction for him. Dr's were present to resurrect him otherwise he would have passed away.

      It is just ensuring they are tolerant to specific medication is vital and O will get thru this issue soon.

      GLTA LONGS!

      Sentiment: Strong Buy

      • 1 Reply to jagan1961
      • Jagan- thanks for staying focused on the issue with Omontys. Everything else is just noise.

        I also believe that the solution is easy, come up with a simple test to determine if a patient will have an allergic reaction to O before first dosing. End of story!

        I also think that Takeda have already completed the investigation and are stalling for time to put a plan together for reintroduction to market or negotiating a buyout. There is a slim chance for bankruptcy...

 
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