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Post by cppoly on Aug 19, 2024 5:43:40 GMT -5
finance.yahoo.com/news/u-fda-grants-tentative-approval-100000113.htmlFDA confirmed that the amendment to add PH-ILD to the YUTREPIA NDA was proper and that application otherwise meets the requirements for approval under the Fede... Final Approval of YUTREPIA for PAH and PH-ILD may occur after expiration of 3-year regulatory exclusivity for Tyvaso DPI on May 23, 2025 Wow looks like tentative approval no earlier than May 23, 2025.
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Post by jkendra on Aug 19, 2024 5:47:47 GMT -5
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.”
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Post by Clement on Aug 19, 2024 6:24:08 GMT -5
"Wow" is right! For the next nine months, UTHR can work unimpeded by competition to accumulate patients and make money on PH-ILD. PH-ILD is where the opportunity lies right now to grow the market for inhaled treprostinil.
And MNKD can get those increasing royalties while progress is made in the MNKD pipeline!
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Post by jkendra on Aug 19, 2024 6:33:03 GMT -5
"Wow" is right! For the next nine months, UTHR can work unimpeded by competition to accumulate patients and make money on PH-ILD. PH-ILD is where the opportunity lies right now to grow the market for inhaled treprostinil. And MNKD can get those increasing royalties while progress is made in the MNKD pipeline! This also helps to solidify future MNKD drugs.
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Post by nxc2 on Aug 19, 2024 6:41:42 GMT -5
LQDA down premarket on tentative approval. UTHR up big (+21) premarket LQDA down big (-5.34) premarket
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Post by peppy on Aug 19, 2024 6:44:49 GMT -5
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Post by agedhippie on Aug 19, 2024 8:16:09 GMT -5
Well that was an option I hadn't seen coming! The FDA effectively said they will approve PH-ILD and PAH, and tossed UTHR a 3year exclusivity on the entire drug class rather than just the drug. I think the FDA comprehensively screwed this up with both sides and is attempting to extract themselves. I suspect now we will see LDQA also suing the FDA! I cannot see an LQDA lawsuit going anywhere, but I think they will file so they can go to discovery on the FDA process paper trail. What is the outcome? From an FDA standpoint there is an approval date on or near 23rd May 2025. In between there is still the '327 lawsuit but I don't think that will make much progress in 9 months.
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Post by alethea on Aug 19, 2024 9:09:10 GMT -5
This news is Very Good for UTHR and FANTASTIC for MNKD.
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Post by thekid2499 on Aug 19, 2024 9:18:02 GMT -5
Can't say I saw that coming but it's nice to be on the side of "big pharma" for once.
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Post by jkendra on Aug 19, 2024 10:21:16 GMT -5
Well that was an option I hadn't seen coming! The FDA effectively said they will approve PH-ILD and PAH, and tossed UTHR a 3year exclusivity on the entire drug class rather than just the drug. I think the FDA comprehensively screwed this up with both sides and is attempting to extract themselves. I suspect now we will see LDQA also suing the FDA! I cannot see an LQDA lawsuit going anywhere, but I think they will file so they can go to discovery on the FDA process paper trail. What is the outcome? From an FDA standpoint there is an approval date on or near 23rd May 2025. In between there is still the '327 lawsuit but I don't think that will make much progress in 9 months. Let's not forget '793 with the Supreme Court. There is also another pesky lawsuit out there regarding trade secret misappropriation. Liquidia is still driving on a very bumpy road.
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Post by cppoly on Aug 19, 2024 10:49:05 GMT -5
Anyone know if LQDA built up inventory of Yutrepia in anticipation of approval? If yes, does that all need to be tossed out based on shelf life now that there's a minimum 9 month delay?
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Post by jkendra on Aug 19, 2024 11:09:15 GMT -5
Anyone know if LQDA built up inventory of Yutrepia in anticipation of approval? If yes, does that all need to be tossed out based on shelf life now that there's a minimum 9 month delay? Looks like the Liquidia Q1 '24 call transcript talks a bit about inventory. Q: Hi. Good morning, guys. Thanks for taking the questions. Just in terms of your commercial prep and readiness, how soon after approval will you launch the drug? Thanks. A: Michael Kaseta addressed the company's readiness for the commercial launch of YUTREPIA, stating that the sales force and commercial inventory are prepared to initiate distribution within days following FDA approval. He highlighted the company's proactive engagement with payers and the readiness to provide immediate access to YUTREPIA post-approval. finance.yahoo.com/news/liquidia-corp-lqda-q1-2024-070350254.html
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Post by gamblerjag on Aug 19, 2024 16:03:16 GMT -5
Anyone know if LQDA built up inventory of Yutrepia in anticipation of approval? If yes, does that all need to be tossed out based on shelf life now that there's a minimum 9 month delay? Looks like the Liquidia Q1 '24 call transcript talks a bit about inventory. Q: Hi. Good morning, guys. Thanks for taking the questions. Just in terms of your commercial prep and readiness, how soon after approval will you launch the drug? Thanks. A: Michael Kaseta addressed the company's readiness for the commercial launch of YUTREPIA, stating that the sales force and commercial inventory are prepared to initiate distribution within days following FDA approval. He highlighted the company's proactive engagement with payers and the readiness to provide immediate access to YUTREPIA post-approval. finance.yahoo.com/news/liquidia-corp-lqda-q1-2024-070350254.htmlHe didn't know it at the time, but he probably should've said at least 280 days 😎
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Post by agedhippie on Aug 19, 2024 17:06:28 GMT -5
Let's not forget '793 with the Supreme Court. There is also another pesky lawsuit out there regarding trade secret misappropriation. Liquidia is still driving on a very bumpy road. I am curious about how the Supreme Court request will go. The trade secret case is not a serious threat, filing that case was pretty standard practice. You can almost always find an ex-employee in possession of something somewhere.
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Post by jkendra on Aug 19, 2024 18:05:04 GMT -5
Let's not forget '793 with the Supreme Court. There is also another pesky lawsuit out there regarding trade secret misappropriation. Liquidia is still driving on a very bumpy road. I am curious about how the Supreme Court request will go. The trade secret case is not a serious threat, filing that case was pretty standard practice. You can almost always find an ex-employee in possession of something somewhere. Wasn't the original filing accusing Liquidia of submitting the stolen blueprints to the FDA that United literally submitted to get FDA approval ? Seems kind of serious to me. I would have to refresh my memory on court documents.
LIQ861 = Yutrepia
During discovery in the patent infringement case, United Therapeutics uncovered evidence that a former United Therapeutics employee took United Therapeutics' trade secrets when he left the company and joined Liquidia to develop LIQ861. The former employee, who was central to Tyvaso's development, brought to Liquidia confidential United Therapeutics documents, including confidential FDA submissions and detailed financial forecasts relating to Tyvaso. On June 4, 2021, United Therapeutics filed a motion alleging that Liquidia used these trade secrets in the development of LIQ861 and seeking permission from the court to pursue these additional claims based on this newly-discovered information. United Therapeutics is seeking monetary damages to compensate it for this misappropriation, trebled damages, punitive damages, attorneys' fees, and injunctive relief.
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