Not as if you can do a trial C1 vs placebo for laryngeal attacks :)Shouldn't they have open label data on various attacks? Does it indicate anywhere that they did receive orphan status?
Makes sense the FDA wants 2 products in the market…
The FDA’s actions in this case vis-à-vis orphan exclusivity are questionable from a scientific standpoint, IMO.
If VPHM and CSL were thinking outside the box, they could outflank the FDA’s rulings by agreeing to co-market both drugs, which would be more efficient for the sales reps from both companies. (The company with the more valuable drug from a commercial standpoint could receive a kicker to make the co-marketing deal equitable.)