Actually there have been 53 drugs recalled around the world (NOT all in the USA) since the early 1960's. That's out of THOUSANDS OF DRUGS on the market. Of those 53 ONLY ONE had anything even close to Omontys AE profile and it was not brought back because it was in a class of antibiotics that had over a half dozen ready substitutes and was absolutely not needed. ALL the rest had AE's and fatality stats FAR WORSE THAN OMONTYS!!! Conversely, there are TODAY IN THE USA, HUNDREDS of drugs with AE and Mortality stats far worse than Omontys.
Finally, it still appears that the 3 fatalities under investigation were anaphylaxic reactions (though that still needs to be proven during the investigation). As such, it was the responsibility of the Dialysis personnel to quickly identify such reactions (WARNINGS WERE REPLETE THROUGHOUT DOCUMENTATION AND TRAINING REQUIREMENTS AS SUBMITTED TO AND APPROVED BY THE FDA) and remedy them. It is not advanced science to know that anaphylaxis is readily and easily treatable if detected in time by the administration of an EPI-PEN or the equivalent. Anaphylaxis the cause, FAULT IS FRESENIUS.
If anaphylaxis should turn out to not be the cause of these 3 fatalities (HIGHLY UNLIKELY) then it will depend on the identification and remedies available to whatever such cause may be. HOWEVER, the probabilities that it was NOT anaphylaxis is exceedingly small or there would have been far more AE's and fatalities evidenced. 25,000 IS a statistically significant population but 3 Fatalities JUST IS NOT!!!
Nobody here knows for sure what happened and we are all applying our own best judgment to this case. In my judgment I have little doubt Omontys will be returned and also little doubt that Affymax has the financial wherewithall to be sustained until that outcome has been determined with 7.5 to $10 million left and a burn rate well under $100,000 per month. And YES I HAVE HEARD THE LEGAL ARGUMENTS...They just don't hold any water NOW.