Dew, ORPH developed xyrem at the request of the fda, yet it was still a controversial approval and is a highly controlled substance. You can speak to theoretical risk or realistic risk. I suppose you can't rule anything out, but still I think it's an unlikely scenario that someone comes in and develops GHB for a new indication to work around xyrems orphan status. We're talking about a $10M selling drug with optimistic upside of $100M or so (imo). I don't think the return would be there for a second entrant.
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