<BDEL>
I've followed them. Key question here is if they can get the FDA to ignore some of the data from one of their India-based trials. If you throw out that data, then their trial succeeded, if not, it failed to show non-inferiority.
The company apparently company claims they know the reason for the bad Indian data - they say some blood samples were transported by land, unrefrigerated.
If the FDA believes them and is accommodating, then the stock is a buy. I don't really have enough information to make an informed decision.
(No current position, but I'm tempted).
Peter