Dum Monkey doesn't understand what he's reading he keeps reading short selling articles that are not factual .....to show how much of a moron you are ....do a simple google search and see how many people die from aspirin each year ....Dumbazz....
now that you see how much of a moron you are ...the facts are the deaths are pointing to human error in the dialysis centers .......not omonty's.....dumbazz...
From: JesseLivermore (Rep: 175) Date: 07/28/2013 12:24
Forum: Wall Street Pit - Msg #2388646 - List AFFY msgs Thread #673552242 (Rec: 1)
Brief Overview: Summary of the Affymax/OMONTYS Story
Affymax's sole drug product is OMONTYS® (peginesatide) Injection ("OMONTYS"), which was approved by the FDA in 2012 and well received by the medical community as a treatment for anemia due to chronic kidney disease (CKD) in adult patients on dialysis. The drug seemed destined to break Amgen's (AMGN) monopolistic stranglehold on this large population therapeutic area, as both drug sales and AFFY share price rocketed.
Then the trouble started. (The cascading waterfall starts here.)
As it turned out, the drug performed very well in a controlled clinical trial environment. Both safety and efficacy surpassed expectations. However, outside the clinical trial environment and into the dialysis center environment where OMONTYS was distributed, results were different and in a very, very small percentage of patient cases, tragic.
Hypersensitivity reactions were reported for approximately 0.2% of the first 25,000 patients receiving OMONTYS, with approximately a third of these reactions serious in nature, including anaphylaxis requiring prompt medical intervention, and in some cases hospitalization. Three patient deaths were attributed to OMONTYS administration, though it is yet not settled whether the cause was the drug or human error, though statistically it points to human error as the most likely possibility.
Affymax and its partner, the global Japanese pharma company Takeda (TKPYY.PK) (eighth largest pharma in the world), made the decision to VOLUNTARILY recall OMONTYS in February of this year. All lots of OMONTYS were affected by this recall. Takeda has committed to fully investigate exactly what happened to those affected patien