Replies to post #252773 on Biotech Values

[DewDiligence]

LQDA/UTHR—Another case where the US Supreme Court’s “Chevron” decision could lead to a lawsuit against the FDA:

https://finance.yahoo.com/news/u-fda-grants-tentative-approval-100000113.html

Dr. Roger Jeffs, Ph.D., Chief Executive Officer of Liquidia, said: “We are pleased that the FDA agreed that our NDA amendment last July was proper, providing a clear path to full approval of YUTREPIA in both PAH and PH-ILD. However, we are disappointed and disagree with the FDA’s decision to simultaneously grant regulatory exclusivity to United Therapeutics for Tyvaso DPI that encompasses chronic use of essentially any dry-powder formulation of treprostinil in the approved indications for a three-year period for its new dosage form approved on May 23, 2022.

We plan to take quick action to challenge the FDA’s broad grant of regulatory exclusivity and defend the ability for patients to have access to YUTREPIA with the least delay possible.”

As I’m typing, LQDA is -31% and UTHR is +8%.