it is going to be very interesting. FDA panel voted for the Drug and FDA approved the drug and did not disapprove the drug.
Since this is a voluntary recall and most of the studies were conducted in Europe I suspect the Europeons might approve the drug with additional usage warning for this type of Allergic reactions and if identified for the not to prescribe for the specific population.
Unlike US, the hospitals provide services in Europe, if the reactions occur within the few hours of administration for the first time, they can provide specific instructions to keep the patient on constant monitoring for the first day of administration during first time administration. This is basically LIFESTYLE change and Europeons will go that extra mile.
Alternatively they can approve the drug and subject to additional review once the reactions are identified and rectified.
O has been pending approval before the EMA since Feb/Mar 2012. Why a decision now after more than a year of pending approval? Now Jagan expects EMA approval for O next Monday. Last Friday, a week ago, Jagan posted that he "wouldn't be surprised" to wake up the next Monday to see the announcement of an AFFY buyout. What do you think this paid pumper's agenda is? All part of what I call Operation AFFY Retail Bagholders. Don't drink Jagan's Kool-aid.
I am not sure about his agenda but definitely know for sure, you are a PAID BASHER! Very good in twisting the facts to misguide and scare people to sell their shares so your employer can buy them cheap.