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Post by agedhippie on Sept 11, 2023 9:53:05 GMT -5
The latter.
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Post by agedhippie on Sept 8, 2023 19:31:57 GMT -5
And, if UTHR wins the trade secret theft lawsuit, it won't matter if they lose the PTAB appeals. How long do you think LQDA can drag out that lawsuit, and if LQDA lost what do you think the sanction would be? Bear in mind that the newest of that material is from 2007 so this would relate to the Remodulin generic at best.
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Post by agedhippie on Sept 8, 2023 19:07:30 GMT -5
I think you are missing the point, the '793 was not found invalid by the District Courts therefore there is a potential that even if the PTAB upholds their decision on appeal the DC can still outweigh the PTAB because they us a higher standard to invalidate a patent vs. PTAB. I guess we will see how long UTHR can drag this through the courts (I've seen other companies do similar things approaching 10 years in the courts). When it comes the US courts they are not speedy, maybe the courts in the UK are faster, so in my opinion the timelines you and other LQDA peeps are so adamant on will most likely be a lot longer. I agree people should have choices but when one company potentially steals trade secrets then they shouldn't be allowed to bring their product to market or should be severely sanctioned. We will see how that plays out. I don't think I am missing the point. The Hatch-Waxman District Court ruling didn't find the patent invalid, they found that LQDA was putting the cart in front of the horse. They deferred to the Federal Circuit who have exclusive jurisdiction over patent law and related issue noting in the written decision that they are aware that the PTAB had ruled the patent invalid and that it was under appeal. If the District Court had ruled for LQDA they would have been pre-judging the Federal Circuit appeal and that is not something a District Court ever wants to do. Why do I think UTHR lose the Federal Circuit appeal? Prior art. The inventor published the work at two conferences before the patent was filed creating prior art and getting past that is a heavy lift but not impossible. The court is going to have to decide if the PTAB erred in deciding this is prior art, and as you pointed out courts are nothing if not unpredictable.
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Post by agedhippie on Sept 8, 2023 14:37:36 GMT -5
This filing is because LQDA filed to have Yutrepia cover PH-ILD as well as PAH. What UTHR is doing is making sure that if UTHR wins the appeal LQDA cannot get Yutrepia approved for PH-ILD. Really this is paperwork though which is why the share price is where it is as nobody expects LQDA to lose that case. If UTHR loses the appeal then the '793 patent is dead and the Hatch-Waxman filing, which this is now part of, is void since you cannot infringe a nonexistent patent. Once again you seemed to ignore that it's not a black & white case... mnkd.proboards.com/post/254256As you and Gregonius (on Stocktwits) speak in definitive terms regarding LQDA 100% winning all the appeals and launching in 2024, I hope people take caution. Not only is it not a certainty that LQDA will prevail, but if they do, it could still take years to go through the appeal process. The other item that I have brought up to Gregonius that he seems to ignore (and you probably will as well) is that the District Courts are not bound by PTAB decisions. The DC ruled that the patent was not invalid. The case is not black & white as you and Gregonius want people to believe, a lot can happen in courts that aren't expected. I've followed other companies that have been in patent disputes where it looked like one side had an iron clad case and end up losing. Again the District Court can supersede the Patent Death Squad aka PTAB and cases can be extended many, many years beyond the averages. Itzafugazi and I have both provided evidence of what I have stated above, so I hope people do their own DD. IMO, UTHR will at the very least do everything they can to drag the cases out to beyond the 2027 patent expiration. What happens when a district court and the PTAB disagree over the validity of a patent?The District Court can indeed disagree with the PTAB over the validity of the patent, as can the Federal Circuit. There wouldn't be a lot of point in an appeal system where this was otherwise! However, the probabilities are not on UTHR's side based on past records of Federal Circuit appeals. That is what the investors are going on and why the share price isn't about 30% lower than it is. We are past the District Court at this point and at the Federal Circuit from which there is no appeal - this is the end of the road. The courts are always a bit of a lottery but right now LQDA has the edge. If you put a gun to my head I would say there is a 90% chance that LQDA wins this, but absolutely as always there is a chance that they lose. If UTHR loses this appeal then they are done with delaying, the stay is void and the FDA will finalize the approval for Yutrepia for both PAH and PH-ILD ( LQDA cannot sell to the PH-ILD market until April). At that point UTHR is forced to compete by providing better outcomes rather than sheltering behind the courts. Just as I don't want to see Afrezza go away I want to see Yutrepia launched and both for the same reason - people should have choices.
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Post by agedhippie on Sept 7, 2023 16:59:36 GMT -5
Liquidia Technologies: United Therapeutics Corporation files lawsuit alleging infringement of Tyvaso patent already found to be invalid by U.S. Patent Office 4:40 PM ET, 09/06/2023 - Briefing.com MORRISVILLE, N.C., Sept. 06, 2023 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA) (Liquidia or the Company), announced today that United Therapeutics Corporation (UTHR) filed a patent infringement action under the Hatch-Waxman Act in the U.S. District Court for the District of Delaware (District Court) asserting infringement of U.S. patent No. 10,716,793 ('793 patent) in response to Liquidia's amendment to add the PH-ILD indication to the tentatively approved New Drug Application (NDA) for YUTREPIA (treprostinil) inhalation powder. The '793 patent was previously found to be unpatentable by the PTAB in an inter partes review (IPR) in July 2022, a decision that was reaffirmed by the PTAB in February 2023.Click here for full release. This filing is because LQDA filed to have Yutrepia cover PH-ILD as well as PAH. What UTHR is doing is making sure that if UTHR wins the appeal LQDA cannot get Yutrepia approved for PH-ILD. Really this is paperwork though which is why the share price is where it is as nobody expects LQDA to lose that case. If UTHR loses the appeal then the '793 patent is dead and the Hatch-Waxman filing, which this is now part of, is void since you cannot infringe a nonexistent patent.
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Post by agedhippie on Sept 5, 2023 16:59:46 GMT -5
I get you are trolling but for the benefit of others; a large part of the CEO’s job is selling the company and these conferences are a large part of how that is done. The CEO needs to reassure existing investors that all is well and they shouldn’t exit, and put the company on the radar of everyone who otherwise couldn’t pick you out of a line up. Nobody enjoys these (I am in the audience for one of these tomorrow) but they are vital for both sides. This is all about visibility and education. I think a partnership announcement would be more useful to the existing investors than these conferences. Existing shareholders could pull up the slides from a few weeks ago and probably gets as much info. I think doing some morning business TV shows would also be more useful. Of course partnership announcements would be better, but those come along at their own pace and have a different audience. A lot of the people who are at this conference wouldn't look at a PR in the blizzard of PR they get hit with - you read PRs from companies you are already interested in. Conferences are about outreach to investors who are not watching you and trying to get them to the interested stage, and making sure that the ones who are interested remain interested. Morning business TV (with the exception of Bloomberg TV) is primarily aimed at retail investors, that's not the target audience for conferences.
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Post by agedhippie on Sept 5, 2023 11:38:12 GMT -5
Attending 3 conferences, how much is it going to cost shareholders with nothing coming out of Attending the conferences? I get you are trolling but for the benefit of others; a large part of the CEO’s job is selling the company and these conferences are a large part of how that is done. The CEO needs to reassure existing investors that all is well and they shouldn’t exit, and put the company on the radar of everyone who otherwise couldn’t pick you out of a line up. Nobody enjoys these (I am in the audience for one of these tomorrow) but they are vital for both sides. This is all about visibility and education.
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Post by agedhippie on Sept 5, 2023 9:03:21 GMT -5
If mnkd quit giving out so much free shares maybe Mike won't sell his shares. Then the company would have to pay cash and that hurts the cashflow (it's not just the CEO but a lot of the employees as well but you don't see that). This way the shareholders pay. These days it's hard to find a listed tech company that doesn't do this. As an example Amazon used to have a hard cash cap of $175k on salary and anything over that was paid in stock, and even then if you were under the cap you were still paid partly in stock.
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Post by agedhippie on Sept 4, 2023 20:39:05 GMT -5
Do you think the CEOs of both companies think their stocks are fairly valued? And what in your opinion is their motivation for selling at this time? The golden rule with stock grants is that if you wouldn't buy the stock at that moment with our own money you should sell stock as you get it. At this point both CEOs probably hold as much stock as they are comfortable with. A large single position is always a bad idea, unless it's paper trading for your newsletter
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Post by agedhippie on Sept 4, 2023 14:30:02 GMT -5
1. Nothing really makes common sense with this stock. Afrezza is the best source of insulin, yet Endos are not prescribing like they should be. Doctors don't care, don't think, don't care to think or do what's best for the Diabetic. They only care about what's easy, Standard of Care, regardless of truth and facts. 2. It is a current and past wonder how TRx can be lower than previous week, but Trx$ be higher than previous week ? How is more money made with less Prescriptions. 3. Financially, MNKD is in the best condition ever. MNKD is making more money than ever. They owe less money than ever. They are on the brink of profit. They're product pipeline is better than ever, yet share price is still miserably LOW ! Endos don't prescribe Afrezza because the last big trial said that it is, at best, no better than RAA so there is no reason to change. The SoC is important to doctors since it represents and evidence based consensus on how to treat diabetes. If you don't have evidence then don't be surprised when you get ignored. This remains blindingly simple - large scale trail data or nothing changes. TRx and TRx$ vary depending on the mix of prescriptions written. A 90 x 4u prescription is a fraction of the price of a 90 x 12u prescription, but they are both 1 prescription. At scale this averages out, but the number of Afrezza prescriptions is still small enough for this to be visible. You are making the assumption that the current status isn't priced in. My suspicion is that without UTHR the share price would still be trading around the $1 to $1.70 channel so the current share price already reflects what you are talking about. The price is sitting here because right now MNKD is largely dependent on the UTHR revenue stream. The price will rise as the revenue stream becomes diversified reducing that concentration risk. Pipelines are always discounted, and not just for MNKD, because so few of them make it to the end. It's trivial to announce a pipeline candidate, but years to get it to delivery and most don't make it. My speculation on this; MNKD has become a proxy, albeit a more volatile proxy, for UTHR. YTD both MNKD and UTHR have markedly under-performed the market; MNKD and UTHR are down 12.5% and 18% respectively, the market is up 17%. That's nearly a 30% gap from the start of the year, and a 35% gap for UTHR, MNKD has out-performed UTHR which makes sense.
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Post by agedhippie on Sept 4, 2023 11:12:25 GMT -5
That's a pretty good article. Your second paragraph nails the problem which is fairly universal - you don't want to be the one educating the market. You see this in Afrezza. It needs to be handled differently from the label and most doctors are (correctly) following the label.
It was the same with pumps, "pens are good enough and don't break down" was a common refrain despite the reality that pumps almost very broke down (I don't know anyone whose pump broke and we were running a Type 1 support group). Gradually the pump companies educated the endos and they started to prescribe them to the point where when I swapped endos around 2010 his first reaction was why wasn't I on a pump and we would fix that (short answer; because I didn't want to be!) This approach is not cheap though. The description of the sort of support pump manufacturers provide is accurate, it's very high touch. Back around 2010 in New York the trainer hand delivered the pump and spent a couple of hours making sure you understood it before they even let you run it with a saline cartridge never mind insulin.
These days they try to get a new Type 1 on a pump ASAP because the data says the outcome will be better, and for kids it's easier on the parents. There is a standard risk management practice where if you have the choice between two broadly equivalent mitigations for a risk you always chose the most familiar and understood of the two. Today that is pumps.
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Post by agedhippie on Sept 4, 2023 10:39:02 GMT -5
Re: TETON study -- inhaled treprostinil for IPF On Aug. 8, 2023 there were changes in Study Description as follows. Old: "Study RIN-PF-301 is designed to evaluate the safety and efficacy of inhaled treprostinil in subjects with idiopathic pulmonary fibrosis (IPF) over a 52-week period." New: "Study RIN-PF-301 is designed to evaluate the superiority of inhaled treprostinil against placebo for the change in absolute forced vital capacity (FVC) from baseline to Week 52." Also the anticipated enrollment changed from 396 to 576. I wonder if those changes mean anything. Is the placebo (nebulized solution without treprostinil) providing health benefits compared to nothing?? And UTHR needs to show superiority with a strong p-value? Can UTHR see results for patients who by now have completed the specified 52 weeks of treatment? Anyone? classic.clinicaltrials.gov/ct2/history/NCT04708782?A=42&B=43&C=merged#StudyPageTopThe question they are asking is if this works. TBH they already strongly suspect they know the answer from work in the INCREASE trial, but they need to prove it (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9402520). There are only four approved treatments for IPF, one of which is nintedanib. I am curious to see where MNKD-201 (inhaled nintedanib) goes in light of this. Was that work being done for a customer? The placebo will be an inert substance delivered by the same mechanism as the real drug.
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Post by agedhippie on Sept 3, 2023 10:08:04 GMT -5
... Anybody know if there are trade shows for orphan lung diseases? Clofazamine and Nintedanib may be noteworthy in 2025 too. This is what you are looking for: conference.thoracic.org/It's the ADA equivalent complete with SoC although the SoC is a bit flaky. Liquidia have presented and exhibited there.
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Post by agedhippie on Sept 1, 2023 8:59:37 GMT -5
Definitely one of the more stupid assessments I have read. They obviously hadn't done any reading on the company.
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Post by agedhippie on Aug 31, 2023 22:03:29 GMT -5
Cool but not entirely correct. Kamen was born in 1951 and started working on his insulin pump in 1971 (wikipedia). This picture shows a 1960's packpack sized pump on the left that was not kamen's. The middle shows Kamen's pump which is not that large. (I don't remember where I found the picture but it was not wikipedia.) View Attachment Lol. Here we are 60 years later and we are only just getting to the dual hormone (insulin and glucagon) pump again from that original backpack sized pump.
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