>>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.
Would that pose antitrust issues?
Frankly, I would prefer VPHM sue the FDA for splitting the indication improperly in violation of the authority granted by Congress to the FDA to grant orphan drug status to promote study of existing drugs (plasma component in this instance).
BTW - I have NO IDEA whether that remedy would lie, but then some IP lawyer should at least understand the idea.
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