Fresenius update was for those who actually believe
That Fresenius was NOT the culprit in the Omontys fatalities !!! The issue is how does Takeda deal with Fresenius as they restore Omontys to market...and I personally believe THIS is what is taking so long for them to complete the investigation and return Omontys and deal with the final Affymax disposition (buyout or royalty trust). JMO
Just to play devil's advocate, pegylation keeps a drug in the system and reduces the chance of hyperimmune reactions. Maybe what we have here is a failure of their pegylation technique and the drug does indeed cause a hyperimmune response.
Mershaw...I don't doubt that if you're referring to anaphylaxis response as it was evidenced in both the trials and post approval on several who did NOT die. But all one has to do is watch the array of commercials for meds ON THE MARKET where they warn "and can cause death" or "can cause death in rare circumstances"...In the case of Omontys the fatality stats 3/25000 patients and far greater dosages, as well as the fatality circumstances (which have been enumerated ad nauseum both here and in various articles/blogs) all point to human error and that points to Fresenius. But we will all only KNOW THIS 100% when the investigation is completed (which i personally believe has already occurred) AND ALL THE NEGOTIATIONS WITH VARIOUS PARTIES has been concluded (and this includes the valuation and compensation to Affymax' shareholders under one of at least two potential options...I do NOT believe bankruptcy is one of them...at least not for the forseeable future). So we sit and wait with our various beliefs. I believe (based on info, analysis and 30 plus years of experience) that this will turn out great for current Affymax shareholders, though perhaps not great for those who bought in the upper $20's. And I personally believe that the arrival of these resolutions is not that far off from now.