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Affymax, Inc. Message Board

  • godwinpeak godwinpeak Dec 8, 2013 8:22 PM Flag

    Attn Newbies. There is no binary event for AFFY.

    AFFY's only product is Omontys [O], an ESA that has proven itself to harm the patients it was intended to help, namely the sicker chronic kidney disease [CKD] patients whose disease has progressed to the stage where they are on dialysis in a clinical setting three times weekly. In terms of efficacy, O is no better than other ESAs such as Amgen's Epogen, Procrit and Aranesp. In terms of safety, O has proven itself to be unsafe for the healther CKD patients who are not on dialysis, and actual patient usage has proven O to be unsafe for CKD dialysis patients. O's only advantage over other ESA's is that O is administered once monthy compared to weekly for Epogen/Procrit and biweekly for Aranesp. O's once a month dosing advantage is about to be lost to Roche's Mircera, scheduled to be introduced into the US market in mid-2014, which also is administered about once a month.

    The AFFY longs, and others manipulating this basically worthless stock, have created the illusion of a binary event when there is no binary event in fact. It is not as if Takeda is now waiting for an FDA decision after submission of a new drug application [NDA]. Instead, Takeda must investigate and determine the cause of O's severe allergic reactions that are so serious patients have died, and as many as 22 patient deaths have been associated with O administration since its limited US 7-month rollout between August 2012 and Feb 2013. The reason O cannot be used for healthier CKD patients, as all other FDA approved ESAs are so used, is because of O's higher number of patients deaths and serious adverse reactions which have been called "inexplicable" and "one for which there is no defenitive answer" by Takeda/AFFY. While Takeda's investigation of O is ongoing, investors have no idea how far it has progressed, how long it will take, or what the results will be. AFFY discloses it will run out of cash by the end of 2nd Q 2014. AFFY faces ruinous class action and products liability litigation.

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