It is my understanding that 208 could get orphan drug designation by the FDA. The FDA wants to stimulate as many drugs as possible for rare conditions. Therefore, it can grant orphan drug designation to similar drugs at the same time chasing the same rare disease.

Furthermore, eculizumab was approved in 2007 for PNH. Therefore, the 7 year exclusivity for eculizumab for PNH should be over by now. 208 could be a much cheaper option for patients. Furthermore, it may me more clinically effective. Evidently, we need to see how the trials go.

Anyway, hopefully someone can delve in to these questions further at the AGM. I suspect someone at the FDA is reviewing the file as we speak.

bfw