Bfw, I hope you are right however it is my understanding that an ODD comes with the market exclusivity of which you spoke and I'm not sure how that could be given to RVX-208 given the existance of Soliris (just as a point of interest I believe Soliris still has protected status wrt aHUS).

Perhaps though, due to the extremely high cost of Soliris, RVX might be considered by the FDA for a Priority Review Voucher, perhaps getting in as a rare pedeatric disease? I would think though, again due to Soliris' price, that RVX-208 could easily qualify as a Fast Track candidate, a Breakthrough Therapy or as an Accelerated Approval candidate based on the definitions for those programs on the FDA site.

The exercise of thinking through this would lead me to believe that RVX-208 might relatively quickly be seen as a threat by Alexion if RVX-208 achieved status in any of the above mentioned programs.