So how long until you think our FDA gives it a thumbs up ? I believe it has been resubmitted or it is close - maybe by the end of 2014 is my thinking. I'm surprised that NICE approved it.
The paperwork on Lemtrada for USA was being resubmitted, but the FDA had problems with the manner in which this study was crafted, and also had issues with the high rates of thyroid dysfunction in the test cohort, as well as some immune thrombocytopenia. They may drag this out, waiting more big numbers from use around the world before they approve it.