7-One main question to investigate is why 3 people died when a simple and timely Epinephrine injection could have saved their lives (Of course we have Epinephrine stand by in all floor in my hospital but even in my solo practice I have had stand by Epinephrine since my day one in practice).
8-It is abundantly and 100% clear to me that because of above Omontys will be back in the market and this may not be even with the need for a new warning or stand by Epinephrine. But even a new warning or stand by Epinephrine is placed on Omontys those are not big issues anyways.
9-I know this was a long note but I've tried to stay away from medical jargons so common folks won't have any problems for a fast reading. I don't believe the issue surrounding Omontys is as complicated as some make it.
CONCLUSION: There were 3 deaths which no way in the world Omontys as originally manufactured could have possibly caused and even those 3 could have been prevented with proper Epinephrine usage. Omontys will be back in the market sooner than most think and that the the company and others investigating definitely already have a pretty good idea what caused the reactions whether they say it this week or hold of for more documentation and proof. Furthermore, the recall was voluntary and Affymax does not legally, medically, or scientifically need but probably will seek and easily obtain FDA's nod and return to market.
It seems somebody gooft or a timely epi injection would have saved all 3 lives. Doc I read all 3 portions of you part III note. Wanted to say thank you for taking time to shed light on a n the issues. I also agree that a voluntary recall is just that: voluntary. Meaning it is basically unto Affymax to decide when it wants to come back to the market although as you say they will easily get FDA's agreement before doing so and if they so choose.