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Post by prcgorman2 on Aug 3, 2024 8:03:13 GMT -5
re: UHTR's PH-COPD study " The PERFECT study (ClinicalTrials.gov: NCT03496623) evaluated the safety and efficacy of inhaled treprostinil (iTRE) in this patient population." "The study was terminated early at the recommendation of the data and safety monitoring committee based on the totality of evidence that iTRE increased the risk of serious adverse events and suggestive evidence of an increased risk of mortality. The change in 6MWD was numerically worse with iTRE exposure than with placebo exposure." pubmed.ncbi.nlm.nih.gov/38811045/This indication is a no-go for Tyvaso. IMHO Since I don’t want to go read the study, and you may have, was the inhaled treprostinil Tyvaso DPI, or the older flashlight-nebulizer inhalable Tyvaso which was a viscous liquid that needed to be warmed before it could be nebulized and inhaled? More generally, I’ve sometimes wondered if TechnoSphere couldn’t be used to treat asthma and/or COPD too. Inhalers are used, but no idea if TS would be suitable to carry a steroid or whatever else is used to treat those ailments.
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Post by agedhippie on Aug 3, 2024 9:45:51 GMT -5
It was the nebulized version. They probably didn't want to use TS because the black box label would have caused delays with getting the trial up and running. It's simpler to start with the nebulized version and if it works do a transition trial for TS.
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Post by Clement on Aug 4, 2024 7:53:07 GMT -5
Yep. nebulized. I feel strongly that UTHR is not going to throw any more money at any form of Tyvaso for this indication.
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Post by Clement on Aug 12, 2024 10:20:11 GMT -5
Re: MNKD's "collaboration and services" (C&S) revenue and Re: UTHR's free drug program aka "Patient Assistance Program" (PAP)
I've puzzled over why has the MNKD C&S revenue been unexpectedly high. A few quarters ago, MNKD told us that C&S revenue would stay flat for a while, but it has grown.
I speculate that UTHR wants to get as many new patients as possible on Tyvaso (free or paid) before Yutrepia comes on the scene. If patients are happy (there's a high satisfaction rate with T-DPI), they may choose to stay on T-DPI. "Free drug" from UTHR to patients will show up at MNKD EC as revenue for C&S but not Royalty. Royalty will come later when the patient continues T-DPI as paid-for script. Therefore, I expect MNKD's C&S revenue to remain high for the near future.
This is my own speculation. C&S includes several things, so it is hard to analyze.
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Post by sr71 on Aug 13, 2024 12:08:01 GMT -5
There must be news: UTHR is down 2.5% and LQDA is up 7%.
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Post by awesomo on Aug 13, 2024 13:04:45 GMT -5
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Post by prcgorman2 on Aug 13, 2024 13:52:17 GMT -5
This helps explain today's price action. A win for LQDA (which has been expected for some time) bolster's Mike's argument MNKD can go it alone on nintedanib DPI (albeit with probable delay from legal efforts to stall).
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Post by anderson on Aug 15, 2024 7:51:39 GMT -5
I feel sorry for those that invested in LQDA thinking UTHR can buy them out. The really should read the MNKD UTHR agreement. I would love to see UTHR buy LQDA and see Tyvaso DPI right fall back to MNKD. That would make our stock price soar. Or how much do you think MNKD would ask UTHR (besides shelving LQDA's product) for to amend the contract to allow UTHR to buy LQDA?
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Post by agedhippie on Aug 15, 2024 9:32:46 GMT -5
I feel sorry for those that invested in LQDA thinking UTHR can buy them out. The really should read the MNKD UTHR agreement. I would love to see UTHR buy LQDA and see Tyvaso DPI right fall back to MNKD. That would make our stock price soar. Or how much do you think MNKD would ask UTHR (besides shelving LQDA's product) for to amend the contract to allow UTHR to buy LQDA? I don't think anyone expects UTHR to buy LQDA, they are well covered with Tyvaso DPI. The buyer would have to come from elsewhere. That said, I seriously doubt there would be a buyer until LQDA has established that it can sell into the PH-ILD and PAH markets.
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Post by agedhippie on Aug 16, 2024 9:49:46 GMT -5
The FDA approval (or not) for Yutrepia should happen today. Place your bets for the outcome. I think they approval PAH and delay PH-ILD. The PAH approval would not be controversial since they granted tentative approval three years ago so any issues would have long since been cleaned up so I think that gets granted. The PH-ILD approval is the point of this law suit so I think that will be a lot less certain but I think it still gets approved because once it is approved for PAH it can be used off-label for PH-ILD. The FDA are not going to want that area sitting outside their scope.
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Post by Clement on Aug 17, 2024 6:41:12 GMT -5
Do we find out on Monday?
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Post by cppoly on Aug 17, 2024 10:12:12 GMT -5
Anyone else feel this is odd? If it were good news for LQDA and it could have been released yesterday, why wasn't it?
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Post by prcgorman2 on Aug 17, 2024 10:38:45 GMT -5
Silence is golden?? (For UTHR and MNKD?)
Not sure what the protocol is for releasing information from sealed documents but wonder if they might or can include instructions to withhold publication of information in the sealed document.
Is it likely it could be some communication other than an approval or denial?
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Post by agedhippie on Aug 17, 2024 15:02:03 GMT -5
The FDA refiled the notice, it's not clear exactly what they did without seeing the documents but it looks like they filed a statement of their proposed actions and were asked to instead file the documents themselves (the court wanted the documents rather than notice of the documents). That is speculation based on Pacer.
That may restart the three day clock, or the court may just say they have known the outcome for three days at this point (I suspect the latter.) Since both sides have their lawyers lined up at this point I think the judge will give his final resolution of the request for an injunction. Previously he had refused an injunction but had asked to be informed before approval was granted, and this is almost certainly approval being granted to at least PAH.
When is this announced? That's an interesting question. Probably Monday, but maybe not until Wednesday or Thursday. When does it get settled? That's a bigger question since it is not impossible that the judge slaps an injunction on the sale of the drug since UTHR got over their skis on this suit and sued before there was the context for a suit, hence the notification clause for when the context did exist. An injunction seems unlikely - however, this is the US legal system so anything is possible...
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Post by jkendra on Aug 19, 2024 5:19:07 GMT -5
LQDA down premarket on tentative approval.
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