Biotech Values

[DewDiligence]

LQDA/UTHR—It's a grey area in the law, which is what the "Chevron" doctrine is all about.

Under the Hatch-Waxman statute, a company is entitled to 3 years of US marketing exclusivity for "new clinical investigation" of a previously approved drug. "New clinical investigation" has generally been interpreted to mean testing the drug in a new indication rather than merely testing a new dosage in an approved indication. But in this instance the FDA decided that UTHR's newly tested dose was sufficient for granting 3-year exclusivity, thereby postponing the launch of LQDA's generic. I don't know what the FDA's reasoning was, but we will find out if this case ends up in litigation.

So, the short answer to your question (Does LQDA have a valid reason to challenge the FDA?) is yes, IMO.