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Post by agedhippie on Aug 3, 2023 10:36:15 GMT -5
Yes, I did. That was the 2nd time. The 1st time was agreeing with whoever said the numbers should be taken with a grain of salt. And I also said, they're unreliable because they're provably under-reporting reality. The reality may be better than the numbers they're showing, and their (FINRA's) paragraph you quoted urges you to believe that. You can if you want to. I don't. I also said it's like having a fox protect the chickens in the chicken coop. The point is, FINRA is unreliable, so the numbers are unreliable, but that doesn't mean you can now be comfortable and complacent. It's the exact opposite. The trading industry is provably less transparent than what they're supposed to be. Do research on the regulatory mandated trading database, the Consolidated Audit Trail (CAT) that's largely useless because implementation has languished since 2016. ... It's an interesting take, but as someone who advised on certain aspects of the current implementation of CAT I would disagree (unsurprisingly ). The early implementations were undoubtably a mess, but the current version is based entirely in AWS (where I came in) which side steps a lot of the issues they had before. Trying to implement data lakes at this scale in-house is a fool's errand so using AWS makes sense. Culturally the FINRA people definitely see themselves as watchdogs and not as apologists for the traders. IMHO the best indicator of short interest is the cost of stock loans. If the short position is material that will always be elevated and if it isn't then what you are seeing is probably noise. You should not rely on the FINRA figures because they are not really gathered for reporting purposes, they are gathered for fraud detection and as such are designed with that purpose in mind. This means that some things that look like short positions are not real short positions (bi-weekly reports aside where firms explicitly report their short positions) and services that take the raw data can easily get misleading results. The more interesting aspect is that while the numbers these services churn out may be suspect they do have value for trading, not because they are accurate but because if enough people believe them and trade on them then they influence the market (perception becomes reality). Data doesn't need to be correct to be traded! And with that I am going to give Peppy her thread back
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Post by agedhippie on Aug 2, 2023 19:20:55 GMT -5
Mike selling before UTHR ER for tax purposes was a bone head move unless he don't think sp is not going up. That is not a choice in his case. He is trading on a 10b5-1 plan.
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Post by agedhippie on Jul 31, 2023 9:09:01 GMT -5
" 120 patients will be randomized in the study conducted in collaboration with the Jaeb Center for Health Research and 20 sites across the country" Is it typical to only have a few (6) patients per site? It seems very inefficient to have to train so many people on the protocol. Those are locations they are drawing from. Just because somewhere is listed doesn't mean anyone will come from there, rather it's the locations where the organizer (Jaeb) has relationships and can possibly find patients. The numbers per site can vary wildly.
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Post by agedhippie on Jul 31, 2023 8:40:39 GMT -5
I would suspect the $3 mil difference is the cost of the API since UTHR would have to buy that somewhere or manufacture it. I wonder if anything can be inferred from that. If one process used more than the other you might be able to roughly work out a ratio by looking at the revenue to cost ratio.
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Post by agedhippie on Jul 31, 2023 8:38:22 GMT -5
From the News Release "INHALE-3 is a 17-week randomized controlled trial with a 13-week extension. ". So we're looking at 6 months for the study, right? How much longer before any results are publicized? Add a year to that at least. Recruiting can easily take six months on it's own. You don't get everyone and fire the starting gun, you add them as they trickle in so it's very spread out. Then there is the run in period, you don't want to just dump people onto Afrezza (or any treatment they aren't used to) as that would be a recipe for disaster - you want them to be up to speed before you start the clock. Finally there is usually a six month data QA process to validate the data and clean up the results. They will be doing well if this makes ADA 2025.
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Post by agedhippie on Jul 29, 2023 15:16:48 GMT -5
Uthr won't switch everyone to the new stuff until they sell their entire inventory of old stuff. Otherwise they have to eat the cost of the old stuff they already made. Switching needs the doctor to change the prescription as it's a different drug (delivery via DPI rather than nebulizer and in different dose sizes.) Martine may want people to change, but she cannot make them change. More to the point she wouldn't do it because it would upset the doctors and no pharma wants to do that.
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Post by agedhippie on Jul 25, 2023 18:43:06 GMT -5
I don't think its just her. Its now become a national story. I think what may have been happening is the T2s stop using it which we saw in the insurance study - about 80% within 2 years. With Wegovy the dosage is a bit higher and these people wanting to lose the weight want to lose the weight. If the T2 gave up in 6 months maybe the dieter tried to push through the pain until it became too bad. I have the feeling these people are too sick to eat much let alone smaller meals. If they were eating large meals I would be surprised. I seriously doubt it's just her. You seem to have a lot of people demanding the drug without understanding how it works and that's leading to this sort of fall out. Here you have a drug that says it works by slowing gastric emptying and people are shocked when it does just that. You eat smaller meals because then your stomach doesn't get so full. It's full stomachs that cause the problem as then you get bloating and nausea. GLP-1 mimics gastroparesis and the management of that is well understood. The problem here is that it's being prescribed by doctors who lack experience in managing complications that behave like gastroparesis. Don't get hung up on the extreme cases, the majority of people have no or minimal side effects.
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Post by agedhippie on Jul 25, 2023 18:23:18 GMT -5
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Post by agedhippie on Jul 25, 2023 18:07:09 GMT -5
Respectfully, I still think it's a valid point to question why the examiners across the divisions of the organization were not in alignment. Did the PTAB change the rules of what is considered patent-able, or is there a lack of communication about those guidelines between the PTAB and the prior examiners? What kind of performance management system is in place to avoid these kinds of outwardly embarrassing conflicts? ... It's a resource problem really. There a huge volume of patents filed and if they were reviewed to the depth used by an IPR the costs to file would go through the roof. As it stands they review the patents and cut out the obvious deadwood. This works because most patents are never used, but stored away was ammunition. It's only at point of challenge that the validity needs to be fully checked, and at that point the challenger will have collected the evidence so it's a matter of judging if the challenge is valid. This works because the challenger has the incentive to spend far more researching the patent than the patent office could.
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Post by agedhippie on Jul 25, 2023 17:55:07 GMT -5
How doctors originally didn't connect Knight's stomach concerns to the Ozempic is frankly disturbing since that is how it works for weight loss. I wonder what bit of slowing gastric emptying they failed to understand. My advice to her would be find a doctor who understands what they are prescribing. For what it's worth you could probably address her problem by following the same approach that you do with gastroparesis; eat more smaller meals, and avoid fiber and fats. If you eat large meals you are going to suffer. There are drugs for treating the nausea from gastroparesis with ondansetron being the favorite.
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Post by agedhippie on Jul 24, 2023 21:58:02 GMT -5
LQDA would have to pay UTHR damages.
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Post by agedhippie on Jul 24, 2023 21:54:34 GMT -5
You answered one of my questions. What does the PTAB ruling mean if the courts say no? Courts already ruled, and upheld, LQDA infringed. I realize one court (two courts in this case) can say "infringed" and another court say "infringement is a moot point". I agree about the popcorn. It's always fun when you can have the USPO issue patents which are debated in courts which rule on the basis of the patents issued by the USPO who then decides, for whatever reasons, "Oh? Did we say these were patentable and issue patents? What we meant was, not patentable." Your tax dollars at play. Queue the circus music. There are two separate court cases running (1) the patent infringement case that just ruled, (2) the IPR appeal case that will uphold the invalidating of the patent. Once the second case rules for LQDA the first case becomes moot since there is not patent to infringe any more. The first case was unwinnable IIMHO, but a bit of a lottery ticket and like most lottery tickets it wasn't a winner
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Post by agedhippie on Jul 24, 2023 16:05:57 GMT -5
YEA!!! That's huge and great news. Thanks for finding and posting that, neil. So, this should mean that Liquidia will have to drop their Yutrepia product, no? Liquidia is down a buck today, but I think it should be down more than that. It is probably not done tanking yet. Why is MNKD not jumping? That makes no sense. Investors are not paying attention. No. Still have PTAB ruling. ^This. The PTAB and subsequent IPR have both ruled the patent invalid so that's done. UTHR are appealing that ruling and those appeals almost invariably fail unless the review didn't follow process which is exceptionally rare. If UTHR lose the appeal then the FDA will immediately grant approval and LQDA will start selling within a month or so. Right now LQDA is presenting papers, and has salesmen out talking to doctors in preparation for launch - they aren't standing still. The CEO of LQDA may have the charisma of a damp dishcloth, but he is extremely competent and was at UTHR for 18 years ending up as co-CEO with Martine. I have my popcorn for this one - www.liquidia.com/management/roger-jeffs
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Post by agedhippie on Jul 24, 2023 15:49:29 GMT -5
As a result, the U.S. Food and Drug Administration (FDA) cannot grant Liquidia final approval for its Yutrepia product until expiration of the ’793 patent, May 14, 2027, except in certain circumstances discussed below.
1. What are those circumstances as it relates to the moratorium? The ‘793 patent relates to a method of administering treprostinil via inhalation. 2. Last year, the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office issued a final written decision in an inter partes review (IPR) of the ’793 patent initiated by Liquidia finding all claims of the patent to be unpatentable. United Therapeutics appealed that decision to the Federal Circuit, and that appeal is pending. United Therapeutics expects that the PTAB decision will not affect the district court’s order barring FDA from granting final approval for Yutrepia unless all claims Liquidia was found to infringe are found invalid following exhaustion of all appeals. Reads to me like once all appeals by UTHR are decided, the FDA approval for Yutrepia will be locked out until 2027 or, it comes down to the Federal decision. By then, seems all UTHR appeals will be exhausted. Right now, today is a victory for UTHR. If and only if UTHR win their appeal against the invalidation of the '793 patent will LQDA have to wait until 2027. Right now the PTAB have ruled that the patent is invalid, the review ruled it invalid, and so UTHR appealed the review (which they will lose.) When UTHR loses that final appeal the patent is struck and the 2027 date becomes irrelevant since there is no-longer a patent to infringe. That's the source of the mid-2024 timeline - it's when judgement on the final appeal is delivered.
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Post by agedhippie on Jul 24, 2023 13:26:24 GMT -5
The court result was highly predictable. Realistically there was no way the court would grant LQDA's appeal while UTHR's appeal against the rejection pf the '793 patent was outstanding. While UTHR is almost certain to lose the appeal the court couldn't put the genie back in the bottle if somehow UTHR won - they have to let UTHR's appeal run it's course before they allow LQDA to start selling.
On LQDA's part this appeal was never going to succeed for the reasons above, but they had to try because it would have taken 6 months off the launch time line as it currently stands (they could launch late 2023 rather than mid 2024). The drop in the LQDA price is people pulling out money for a few months and investing it elsewhere before coming back nearer the launch date (there's little point in leaving money tied up going nowhere for 6 months.)
The bottom line is that the launch remains on target for mid-2024.
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