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Post by agedhippie on Mar 29, 2024 17:31:27 GMT -5
UTHR lost their bid for an injunction in their suit against the FDA today, the judge ruled from the bench. UTHR can carry on suing the FDA, but they cannot prevent the FDA from approving Yutrepia for PAH or PH-ILD.
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Post by agedhippie on Mar 29, 2024 9:03:25 GMT -5
Weighed on LQDA too, not just UTHR and MNKD. Last I looked, as a percentage of share price, LQDA got hit worst. This too shall pass I assume. The market likes winners enough to over react. At some point, it comes back to fundamentals. Is the new drug complimentary or competitive? It can be both but judging the impact takes time, not just reactions in the moment. I think this passes. The market always overreacts and reversion to mean works in both directions so I expect everyone involved to drift higher. Oddly UTHR's PH-ILD approval may have saved LQDA's neck given the PAH market. I think LQDA will do ok with PAH, but without the PH-ILD market I suspect their valuation would struggle.
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Post by agedhippie on Mar 28, 2024 16:02:56 GMT -5
As expected Judge Andrews has ended the stay on Yutrepia. They are now clear to launch once the FDA approves which I expect in the next week or two. There is the oral hearing for the UTHR's suit against the FDA tomorrow - I will have my deckchair and popcorn out for the event!
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Post by agedhippie on Mar 26, 2024 21:45:52 GMT -5
Martine addressed this as a complimentary product and have not heard anything from Merck to the contrary. With the push on for another plant to cover additional demand on TDPI Im believing this is a dead issue except for the sake of promoting FUD. It's a complimentary product for people already on Tyvaso. However, the aim with new patients to use it early paired with the first line drugs stopping the progression before you get the point of needing Tyvaso. It can have unpleasant side effects so some people may not be able to tolerate it, although since the option is dying patients may be prepared to live with ones that are not actively life-threatening.
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Post by agedhippie on Mar 26, 2024 21:37:00 GMT -5
This is going to fall into two parts; existing patients and new patients. They will add this to existing patients treatment if the patient is stable so the base treatment remains. The new patients are more interesting and the couple of reports I read said they will use this as early as possible, ideally at diagnosis, and then they can use simpler drugs (sildenafil or tadalafil) with the aim of stopping the need to move to things like treprostinil. It is not going to work for everyone though.
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Post by agedhippie on Mar 16, 2024 12:23:55 GMT -5
Wells Fargo published an interesting report looking at the UTHR share price. The thesis was that the competition is already priced in so they don't see the introduction of Yutrepia having a significant share price impact. This was partially done as a justification for why they had raised the UTHR target price. They published a sales projection for market share of the Tyvaso DPI market out to 2040 (!) starting out with LQDA capturing 3% of the market this year, and 11% next year then growing at about 5% per year before eventually settling to a 45% UTHR, 35% LQDA, 10% generic split. Between 2024 and 2032 they expect the market size to double. LQDA earnings were not so great. Do we think they will be around in 2032? MNKD had the Mann Foundation as a safety net. Whats LQDA's plan? The plan is to launch Yutrepia. That, and over two years cash in the bank. If Wells Fargo are to be believed in their market projections for UTHR then Liquidia will have a gross revenue of $150M next year. Of course projections are just that until they are realized.
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Post by agedhippie on Mar 16, 2024 10:53:22 GMT -5
Wells Fargo published an interesting report looking at the UTHR share price. The thesis was that the competition is already priced in so they don't see the introduction of Yutrepia having a significant share price impact. This was partially done as a justification for why they had raised the UTHR target price.
They published a sales projection for market share of the Tyvaso DPI market out to 2040 (!) starting out with LQDA capturing 3% of the market this year, and 11% next year then growing at about 5% per year before eventually settling to a 45% UTHR, 35% LQDA, 10% generic split.
Between 2024 and 2032 they expect the market size to double.
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Post by agedhippie on Mar 15, 2024 13:32:27 GMT -5
The full article suggests that UTHR are unlikely to get a friendly hearing from Judge Andrews. It quotes his "The sense I get is that the Plaintiff is simply trying to run down the clock" comment when he granted Liquidia's request to use material from the '793 case in the '327 hearing. I cannot see him letting the injunction remain in place for a Supreme Court appeal that everyone know will be rejected. Your words, not his. The courts may do the right thing here. Everyone knows LQDA infringed on UTHR patents... The Supreme Court picking up a unanimous non-precedent ruling from the CAFC upholding a PTAB finding and with a rejected en-banc appeal? Yeah, right. Although I suppose it's all billable hours
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Post by agedhippie on Mar 15, 2024 12:27:54 GMT -5
news.bloomberglaw.com/ip-law/united-therapeutics-to-take-lung-drug-patent-fight-to-high-courtUnited Therapeutics Corp. plans to petition the US Supreme Court by June 10 to review its failed bid to revive a patent for its blockbuster lung-disease drug, Tyvaso, canceled by an administrative tribunal , according to a filing in Delaware federal court. UTC urged Judge Richard G. Andrews to deny Liquidia Corp.'s request to remove part of his 2022 judgment blocking final approval of its rival drug, Yutrepia, according to a letter filed Wednesday in the US District Court for the District of Delaware. The filing argues Liquidia’s request is premature a day after the company touted a favorable Federal ... The full article suggests that UTHR are unlikely to get a friendly hearing from Judge Andrews. It quotes his "The sense I get is that the Plaintiff is simply trying to run down the clock" comment when he granted Liquidia's request to use material from the '793 case in the '327 hearing. I cannot see him letting the injunction remain in place for a Supreme Court appeal that everyone know will be rejected.
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Post by agedhippie on Mar 14, 2024 20:31:34 GMT -5
Gestational diabetes would be an interesting as while by no means all women with gestational diabetes are put on insulin those that are currently put on RAA would be strong candidates for Afrezza instead. It would require trials but there is an additional benefit in doing a proper trials which is T1 pregnancies. Doctors want very tight control while you are pregnant and that is a lot of work. I could see a definite role for Afrezza there if it was approved. The ER example wouldn't work for a few reasons. The likelihood if you are in the 800s without DKA and are in ER it's because you cannot afford insulin and almost certainly don't have insurance. This happens more commonly than you would think with a cycle of about a month or so. The biggest problem though is that if you dropped someone from 800 to 100 in the space of a couple of hours there is a strong chance you will kill them with hypokalemia. High insulin doses suck potassium out of the blood so you have to drop that sort of level relatively slowly to void cardiac issues. If they are 800 with DKA then getting their level down is literally the last thing you do. High levels will not kill you, but the electrolyte imbalance caused by DKA will and fast. That means an IV is required and used for everything including insulin. DKA is fatal in about 1:300 cases in the west, couple that with virtually all kids being diagnosed with Type 1 because they are in DKA... In the list of things that scare T1 diabetics DKA is usually top. Everyone I knew who has died from diabetes died because of DKA, never hypos. I 100% agree. There would be a good chance of killing the patient. However, it would be really nice to send them home with a CGM and afrezza and icodec. Next month should be approval. I am not sure which part you agreeing with but the "next month" part leads me to think it's kids in DKA. The problem is not insulin killing the child (that is all IV delivered so ultra fast acting and clearing), but the electrolyte imbalance and dehydration caused by their blood turning acidic. The first thing they do is give the patient fluids and electrolytes for at least an hour. If you don't do that they absolutely will die. After that they will start to introduce insulin via the IV *slowly*. If the level drops fast the patient will lose all the electrolytes you have carefully been replacing and be critical again. The insulin stops the ketoacidosis and now you just leave the patient on an IV mix of saline, glucose, and insulin and observe.
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Post by agedhippie on Mar 14, 2024 12:30:15 GMT -5
Following on from my last post...
I don't really like to say this because it sounds bad, but if you have gestational diabetes there is a strong chance that you will get Type 2 later in life so if you were treated earlier with Afrezza there would may be a strong preference for Afrezza if diabetes returned.
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Post by agedhippie on Mar 14, 2024 8:49:50 GMT -5
I was real glad to get that email from Schwab but sorry to see that it did not include shortened days for transferring funds and the hold they put on them. Interactive Brokers credit your account immediately, but you cannot withdraw the money for a few days. Sir is welcome to spend it in our casino though...
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Post by agedhippie on Mar 14, 2024 8:46:19 GMT -5
Afrezza for gestational diabetes could be a literal lifesaver. From ST...... Did anyone catch Mike mention they will be seeking approval for Gestational Diabetes and HOSPITAL CARE??? Once PEDS is approved I’m sure they will be going for a MAJOR LABEL CHANGE. Can you imagine a diabetic going to the ER with a 800 BG and staying there for 2 hours instead of 12 hours??? How much of a SAVINGS is that?? Gestational diabetes would be an interesting as while by no means all women with gestational diabetes are put on insulin those that are currently put on RAA would be strong candidates for Afrezza instead. It would require trials but there is an additional benefit in doing a proper trials which is T1 pregnancies. Doctors want very tight control while you are pregnant and that is a lot of work. I could see a definite role for Afrezza there if it was approved. The ER example wouldn't work for a few reasons. The likelihood if you are in the 800s without DKA and are in ER it's because you cannot afford insulin and almost certainly don't have insurance. This happens more commonly than you would think with a cycle of about a month or so. The biggest problem though is that if you dropped someone from 800 to 100 in the space of a couple of hours there is a strong chance you will kill them with hypokalemia. High insulin doses suck potassium out of the blood so you have to drop that sort of level relatively slowly to void cardiac issues. If they are 800 with DKA then getting their level down is literally the last thing you do. High levels will not kill you, but the electrolyte imbalance caused by DKA will and fast. That means an IV is required and used for everything including insulin. DKA is fatal in about 1:300 cases in the west, couple that with virtually all kids being diagnosed with Type 1 because they are in DKA... In the list of things that scare T1 diabetics DKA is usually top. Everyone I knew who has died from diabetes died because of DKA, never hypos.
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Post by agedhippie on Mar 12, 2024 20:46:35 GMT -5
The courts rejected UTHR's request for review so the '793 patent is now dead. That means the stay on Yutrepia will be lifted (there is no patent to violate) and no longer block FDA approval. In the short term I don't expect much impact on share prices as this was pretty much already priced in.
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Post by agedhippie on Mar 11, 2024 16:31:30 GMT -5
Gosh, one might think the Inhale-3 results disseminated today were very, very poor based on the near 14% drop in MNKD's stock price. BUT any long time watcher of MNKD knows it's just the shorting, Street hedge fund almost criminal gunslingers doing their dirty work. Not surprised... was expecting this. Finding it oddly reassuring in that it tends to confirm the nasty manipulation thesis. They weren't poor, they just weren't new. At least stop providing the gunslingers with ammunition.
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