Research PML. I forget what it means. To us, it means that 2 people died while on Tysabri. out of 30,000+ that have been on it. Maybe it was 3 people. Point is that Tysabri was FDA approved... then it was yanked over the deaths that were found to be related to the cocktail of immunosuppresants (6MP, Immuran, etc...) and the drug.
Then, there was the unrelated death where no immunosuppressant was in use. In Europe, back in April or May of last year.
Bottom line: Tysabri has to cover their @sses, just as you've said.
Don't forget that Tysabri was in use w/ MS patients long before CD... so there were many people on it before the deaths. I don't know whether the dead people had MS or CD... no matter, it is a PITA!
But once it is done, you are good to go.