Did you ever wonder why the European Medicines Agency issued a statement that the studies Takeda filed in support of its MAA for Omontys might not be reliable? Do you ever wonder why the plaintiffs in the securities class action allege that AFFY knew about O's anaphylaxis problem from O's clinical trials, but purposefully hid the anaphylaxis results in its efforts to get O approved by the FDA?
Here are some clues: Neither the PEARL studies nor the EMERALD studies when I read the patient safety results reported anything about anaphylaxis as an adverse event. However, the PEARL studies reported that O had 7x more sudden death than Epo, 2x more death from unknown cause than Epo and 4x more patients who experience convulsions than Epo.
Significantly, AFFY also admitted that the EMERALD/PEARL results could be biased in favor of Omontys over Epogen due to what it described as "limitations", specifically (1) the studies' open-label design, and (2) the number of premature patient withdrawals that may have influenced the results. See Fishbane, et al., Peganistade with Anemia Undergoing Hemodialysis, NEJM (Jan 24 2013).
Third. AFFY did mention anaphylaxis, somewhat as an aside, in connection with 12 O studies' patients who developed O antibodies. In that connection, it was reported that "No patient had an allergic drug reaction, including anaphylaxis, associated with the formation of antibodies." Id.
I suppose the FDA could always require O be distributed with REMS requiring an Epi pen and/or Benadryl and black box warnings for anaphylaxis despite nothing like this with Epo. AFFY can always blame the severe anaphylaxis reactions on the ineptitude of its customers, namely dialysis centers, but this might not be a winning sales strategy. For example, from the Bartelt amended complaint: "The label change [warning of anaphylaxis] apparently slowed clinics from converting from Epogen use to OMONTYS, stating that one Fresenius clinic in Tennessee told CW 3 that they could not convert to OMONTYS because they did not have a supply of Benadryl on hand."
I don't think Omontys customer base would need to worry about liability/lawsuits considering your admonition that anaphylaxis is so easily treated right jose? They are going to be eager to order O despite Mircera/Aranesp/Epogen/Procrit proven safe and effective to treat anemia in ALL CKD patients without the anaphylaxis worries right jose?
You are so negative. It's not hard to see your intensions. You must live on this board to bash. Everyone here is aware of the possibility this drug may not (but most likely will) be reintroduced back into the market. So you are just wasting your time trying to convince the longs to sell. You are on ignore.
Ask yourself these questions honestly while you hold tightly onto AFFY shares. If you are looking to profit on MM and Maxdad manipulation, then also be honest with yourself. Retail, to my knowledge, cannot short AFFY. Retail can only go long AFFY. I cannot bash a penny stock like AFFY. Instead, the lack of AFFY fundamentals is why the share price drifts lower after the Exp/Maxdad pumps.