allergic reactions were 1:1000 that means 18:18000
most of that 18 were mild, lets say 14
a small number, say 4, had serious allergic reactions, that's 4 out of 18000 !
only fools can dare to doubt and short AFFY and Omontys
i believe its an utter important medication for human-kind
The error in your argument my friend is that you equate allergic reactions with adverse reactions. They are not the same. Allergic reactions are a small subset of adverse reactions. The Fresenius letter only mentioned allergic reactions and was completely silent about any other type of adverse reaction to Omontys. My question remains: Why would Fresenius suspend the rollout of Omontys if it were performing so well?
The reaction rates were similar but were mild in the phase III studies. The post marketing was done on drug in multi-dose vial. Also, 30 minutes after treatment...sounds very much like Anaphylatoid reaction, which for all intensive purpose appears clinically like an Anaphylactic reaction. You still give Epi when you are not sure...thus in a frail population (dialysis dependent patient), this could result in the heart attack or death. However, the difference is IgE (anaphylaxis) verus non-IgE mediated (anaphylactoid).
CEO and Medical Officer didn't seem to be panicking. I think they are fairly confident that the reaction will likely be attributed to the preservative in the multi-dose vial. They will likely consider going back to the single vial formulation from their phase III trial. They will do another post marketing with this formulation and those who bought as the herd jumped off the cliff will be sitting pretty.