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Affymax, Inc. (AFFY) Message Board

  • godwinpeak godwinpeak May 16, 2013 11:06 AM Flag

    Heads Up For AFFY Longs - Keep the Faith No Matter What

    First. I guess everyone knows there is no AFFY buyout. It seems to me that the Longs have been saying a buyout is imminent by usually Takeda, but I have also heard the long pumpers tout an Amgen buyout, a Roche buyout and a Pfizer buyout. I guess if enough idiots keep saying AFFY will be purchased soon at a share price that will make the longs rich, then some might even come to believe it.

    Second. It does not appear the Old Monty, Killer O, Omontys, or peginesatide will be approved for reintroduction by the FDA, or receive final approval by the European Medicines Agency or approval in Japan anytime soon. It takes a long time to ascertain the causes of the patient severe adverse reactions, and it is likely that the FDA will require Takeda to undertake a new study to reestablish O's safety profile. AFFY even says the FDA discussions include "voluntary withdrawal" of O's NDA (sort of like the "voluntary recall" huh). O's application before the EMA has been pending since March 2012, and with O now recalled in America, what are the odds the EMA will now approve O. Takeda has so much confidence in O that it announced last October 2012 that it had decided not to market O in Japan. The only clinical trials for O have recently been approved by the EMA for CKD patients on dialysis who are under 18 - and are scheduled for completion by 2027.

    Third. There is some valued to the Takeda milestone/royalties agreement, but Takeda controls its value because ALL depends upon WHEN AND IF Takeda decides to recommercialize O, which AFFY itself describes as HIGHLY UNCERTAIN. Should AFFY seek Chapter 11 reorganization, which would free it from the burdens of securities class action litigation, derivative shareholder litigation and any products liability litigation, the Takeda milestone/royalties agreement might be sold to another entity, or retained by the restructured AFFY. In either event, current AFFY shareholders will get little or nothing for their shares.

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