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Affymax, Inc. (AFFY) Message Board

  • godwinpeak godwinpeak Sep 30, 2013 4:15 PM Flag

    Pfizer Prepares for Voluntary Withdrawal of FDA Mylotarg NDA

    Pfizer Inc. announced today that based on discussions with the U.S. Food and Drug Administration (FDA), it will be discontinuing commercial availability of Mylotarg® (gemtuzumab ozogamicin for Injection) (used for the treatment of relapsed acute myeloid leukemia (AML)) in the United States and that it will be voluntarily withdrawing the new drug application (NDA) for Mylotarg effective October 15, 2010....

    Mylotarg administration can result in severe hypersensitivity reactions (including anaphylaxis), and other infusion-related reactions which may include severe pulmonary events. Infrequently, hypersensitivity reactions and pulmonary events have been fatal. In most cases, infusion-related symptoms occurred during the infusion or within 24 hours of administration of Mylotarg and resolved.

    See AFFY longs. It can happen. AFFY disclosed in its Apri 2, 2013 press release that there are "discussions with the FDA including a potential withdrawal of the OMONTYS New Drug Application (NDA)."

    Should that happen, I am confident that the AFFY longs will not be deterred and spin it as a bullish move for AFFY stock. Jagan most likely will say that it is just Takeda preparing for a lowball offer to buy AFFY in the $5 range.

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    • ANOTHER MASSIVE DISTORTION BY OUR CHIEF DISTORTION OFFICER GODWINPEAK...But JUST to show what a lying little weasel he is I would suggest anyone who would buy into this totally irrelevant extrapolation to Google the following to see that it couldn't be more of an APPLES V. ORANGES comparison he has just made (as he has shown us he'll attempt at nauseum)...GOOGLE : Mylotarg Adverse Events OR Mylotarg Fatalities AND Mylotarg Efficacy and you will find that if you just put Omontys up against Mylotarg on a statistical level, OMONTYS HAS PROVEN EFFICACY (Mylotarg's questionable at best) AND A MUCH LESS SEVERE AE and Mortality rate. NICE TRY CONMAN, but the problem for you is that it is SO EASY TO DISPROVE YOUR LIES!!!

    • Found 1 more little thing GWP.....Pfizer pulled the drug in June 2010 after 10 years on the market. The Food and Drug Administration requested the company stop selling the therapy after a clinical trial showed it didn’t help patients and was tied to deaths from liver complications......

    • So GWP why was it recalled? My opinion is because it showed no clinical benefit for the patients......What's yours? Never mind I already know.......

    • Mylotarg was granted an accelerated approval to allow patient access to what was believed to be a promising new treatment for a devastating form of cancer,” said Richard Pazdur, M.D., director, Office of Oncology Drug Products, part of FDA’s Center for Drug Evaluation and Research. “However, a confirmatory clinical trial and years of postmarketing experience with the product have not shown evidence of clinical benefit in patients with AML.” .............(YEARS OF POSTMARKETING EXPERIENCE WITH THE PRODUCT HAVE NOT SHOWN EVIDENCE OF CLINICAL BENEFIT IN PATIENTS WITH AML.)

    • Under accelerated approval, the company is required to conduct additional clinical trials after approval to confirm the drug’s benefit. If those trials fail to confirm clinical benefit to patients, or if the company does not pursue the required confirmatory trials with due diligence, the FDA can withdraw the drug from the market using expedited procedures.

    • Pfizer Inc. today announced the voluntary withdrawal from the U.S. market of the drug Mylotarg (gemtuzumab ozogamicin) for patients with acute myeloid leukemia (AML), a bone marrow cancer. The company took the action at the request of the U.S. Food and Drug Administration after results from a recent clinical trial raised new concerns about the product’s safety and the drug failed to demonstrate clinical benefit to patients enrolled in trials......... AT THE REQUEST OF THE FDA, THE CLINICAL RECENT CLINICAL TRIAL RAISED NEW CONCERNS, THE DRUG FAILED TO DEMONSTRATE CLINICAL BENEFIT TO PATIENTS ENROLLED IN THESE TRIALS.............I'll finish reading the rest now might find more stuff

 
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