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Post by agedhippie on May 21, 2024 7:25:22 GMT -5
I'm also curious what agedhippie thinks. Given LQDA was up 5% today you would have thought investors were celebrating UTHR's petition. This goes nowhere. The manufacturer is YS Lifesciences, not LGM as UTHR claim so the cGMP issue UTHR raises is irrelevant to LQDA. This is purely an attempt at a delaying tactic. LGM is just the importer so if this was going to impose a delay LQDA would simply switch importers. Doing a quick spot of research (I have been slacking on the LQDA front) this was bought up at the BoA Healthcare conference and the response was that in the FDA have not been in touch with them in the year since the consent order was issued, and that the petition inaccurately identifies LGM as the manufacturer of the drug. The FDA action would be to review the data associated with the petition relating to the complaint. If it's lung safety they will want to see the lung data, if it's a supplier they will want to see the supplier's role. The delay is directly related to the complexity of the review which in this case is trivial (show that the drug is not manufactured by LGM - evidenced by the contracts with LGM for the import and YS Lifesciences for the manufacture.) UTHR also rather misses the point of a consent order - it's not to prevent a company from doing business (nobody can use a drug you handle) but to provide a legal framework allowing the company to continue doing business in exchange for remediating an issue. In other words a consent order is not disqualifying for a supplier.
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Post by agedhippie on May 19, 2024 15:36:14 GMT -5
... Those cost per perscription and per patient blow my mind. I have to wonder what is the insurance coverage like in that situation? And, how many of the 122,000 NTM patients are going to be treated using MannKind’s nebulized formulation of Clofazimine? 1%? 2%? 20%? And how much is prescription cost a barrier where lower per perscription pricing could be recovered and exceeded by larger volumes of market penetration? ... The question is where it is classed as a pharmacy or hospital benefit. Pharmacy benefits are tightly controlled by the PBM, hospital benefits are medical benefits rather than pharmacy and pretty much most things go. My suspicion is that this will be a hospital benefit since I suspect the patient will be treated in hospital. But to be clear, that is a guess. An example of this is DME such as pumps. With the exception of the Omnipod these are covered under medical insurance. Omnipod can be either and so depends on who you can get the best deal from.
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Post by agedhippie on May 13, 2024 19:18:40 GMT -5
It's anyone's guess why the best prandial insulin the world has ever known has such embarrassing sales after a decade, but the technology behind it is a potential goldmine. IMO. And there we have the core biotech quandary of our time, eh? When we get a good answer to that, someone will have to write the book. That's easy. Afrezza is non-inferior and people, including Sanofi, thought Type 1s would jump at the chance to stop taking shots. The reality was that for Type 1s modern needles and pens make it a non-event and the idea of changing was not seen as worth it (ten years previous to launch that may not have been the case.) From the endos standpoint they had an insulin that was equivalent to RAA, maybe slightly worse, whose sole virtue was that it was inhaled and having just seen an inhaled insulin flame out they were not interested. Basically there was not a market and that is why Sanofi bailed out. What could have changed that? Data. Sanofi was on the hook for some trials, which they did, but MNKD just stepped out. Nobody was willing to do the follow on trials to improve the label. Not Sanofi as financially it was problematic, and not MNKD because they saw that as Sanofi's job. The result was that you lost the one group who could have driven sales and forced insurance cover, the endos because MNKD/Sanofi was not giving them a reason to prescribe Afrezza other than, look no needles! At launch the FDA required three further trials; pediatrics, cancer incidence, and a variance trials. Only the variance trial was done. The FDA has not pressed on the cancer trial because the sales were so low, and ten years later we finally have the pediatrics trial. This is the sort of response which makes endos wary. Now with INHALE-3 we finally have the sort of trial that will get attention. The problem remains though that in the interval a view formed on Afrezza and that means the market has to be educated and be persuaded to take a look. There is indeed a book in this, just not the sort of one people usually want. It's a great case study of not understanding your market, and failing to compensate.
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Post by agedhippie on May 13, 2024 8:59:41 GMT -5
I would expect a timeline that follows the trial data, pediatric approval and the standard of care being frequently discussed in the industry...hopefully by early 2026. If the trial results are as expected, a P/E multiple will be less of a consideration than what the other BPs are willing to pay. Two of the big three BPs can't sit idle by and watch the other run with this. This is when it could get interesting. As usual, plenty of ifs and just one opinion. The three players here Novo Nordisk, Eli Lilly, and Sanofi. The first two will not want to cannibalize their RAA market which is a duopoly. The third is Sanofi... I don't really see a BP buyer outside of these three but I may be missing someone.
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Post by agedhippie on May 13, 2024 8:52:33 GMT -5
... I haven’t studied buyout premiums but I will speculate anything approaching or above 2x the share price is uncommon. This is kind of like P/E in that the buyer has to be confident of future performance and willing to pay above what the market at the moment is willing to pay. ... Afrezza is still the only ultra-rapid acting insulin (short of an I/V in a hospital) and doesn’t require needles (or refrigeration), so hope springs eternal, but the margins on mealtime insulin have fallen, so do I think any large BPs are salivating over buying MannKind at this point in time? No. ... You are correct in that it would be politically extremely hard for a company to pay over twice the closing price for established drugs. I would say around 60% premium would be a good result. The high buyout premiums go to a prospective drug in a key area (cancer typically) rather than a drug in production. TBH at this point drugs like 101 and 102 probably have more value than Afrezza (Tyvaso DPI will have a low multiple as it's a delivery mechanism rather than a drug.) The problem for Afrezza from a BP view is that it has been on the market for ten years so it's value can be quantified, and it's abysmal sales over that period mean the valuation will not be good. At this point the only option is for MNKD to retain Afrezza and work on building it's profile to improve coverage and acceptability in the medical community. Once that is accomplished it will be revalued. RAA is only refrigerated for long term storage the same as Afrezza. The RAA label specifically says don't refrigerate once you start using a pen. The distributors and pharmacy have to handle drugs in accordance with the label which for insulin means refrigerated shipping and handling which drives up the costs. From a customer POV it does mean that you get free next day shipping from mail order pharmacies without having to pay extra although you end up with a lifetime supply of ice blocks and poly boxes.
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Post by agedhippie on May 10, 2024 14:32:03 GMT -5
So, none of you have any hope for the possibilities of the V-go device. An FDA approved drug delivery device that doses at a controlled rate mechanically without all the electronics. All of you can ONLY see insulin being delivered? Even though Al Mann himself was intrigued and following this product closely before he passed? Then you have no imagination. I’ve immediately pictured fertility drugs for the device because of my personal experience and watching my wife become a human pincushion for the better part of a decade. Then I go to anti nausea drugs for cancer patients who get awakened by alarms beeping from current electrical devices due to crimped hoses or low batteries or dislodged IVs. There are probably countless drugs to be loaded onto V-go but we only just started making enough to thoroughly consider the possibilities. Pleas restore my faith in the intellectual abilities of this board and come up with something……somebody? I’ve given my favorite two here. There a ton of drugs that are delivered via syringe drivers where V-Go could be substituted, a hospital pharmacist could give you a full list. You would need drugs that have a fixed delivery rate as the V-Go is controlled by the spring strength so it can only be set at manufacturing time so it cannot be varied.
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Post by agedhippie on May 10, 2024 12:54:33 GMT -5
So we are agreed that there never been a trial between metformin only and Afrezza, and that the 175 trial had people on multiple oral meds? Do you not understand the 175 trial? The bottom line is afrezza is superior to metformin and metformin plus a bunch of other meds. The trial for people where the treatment has failed, yes I understand that was the point of the 175 trial. Do you understand that contrary to your claims there has never been a trial between metformin only and Afrezza, and that the 175 trial had people on multiple oral meds?
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Post by agedhippie on May 10, 2024 10:59:43 GMT -5
OK - Metformin Only 42 participants and then 40 for afrezza and metformin. You want more? Its not going to matter. Metformin will still lose. It could be 42,000 and it will still lose. Are you trying to tell us Metformin will beat afrezza? So we are agreed that there never been a trial between metformin only and Afrezza, and that the 175 trial had people on multiple oral meds?
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Post by agedhippie on May 10, 2024 8:19:58 GMT -5
Ah, ok, thanks. Mike didn't say anything about a TS version of Clofazimine on this last call, but he has said that was under consideration in the past. I'm ambivalent. Clofazimine DPI would need to provide some cost/performance benefit over the liquid version they're testing to accelerate the timeline to get to market. I'm excited about the product they're testing in the upcoming Ph3 trial in terms of how much more likely it is to help as compared to the oral version on the market today. And getting some (major?) portion of a $3.7B market is definitely going to help the debt-free bottom-line. I don't think Clofazimine is a multiple times a day inhalation, so I really don't see much of an advantage to a technosphere version since one isn't having to worry about carrying a nebulizer around. Seems questionable whether it would ever make sense to spend the money on DPI version. They have a developed product on it's way to FDA approval and a relatively small but lucrative market. There isn't really a financial reason to put it on DPI. They would take the financial hit of doing the work and of running a conversion trial like UTHR did.
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Post by agedhippie on May 10, 2024 8:13:38 GMT -5
Where to start. 175 compared metformin. In fact in one arm we had metofrmin alone. In the other we had afrezza added to metformin. ... ROFL. You entirely made that up. Read the filing ( classic.clinicaltrials.gov/ct2/show/NCT01451398) and point at the metformin only arm. Nice try though.
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Post by agedhippie on May 9, 2024 17:04:46 GMT -5
... Then we have the smallest circle, gestational. We already know nothing beats afrezza post meal. Can we just help these soon to be moms sooner than later? Mike said aside from metformin they have nothing but insulin for this market. How did afrezza do in a large scale trial against metformin? Hmmm, I believe it was found to be superior. ... Let me explain this for you. Using Afrezza for gestational diabetes is off-label since it is not approved for use during pregnancy. My bet is that some endos are using it in those cases just as some are prescribing for kids, most are not going to prescribe off-label which means a large scale clinical trial. Afrezza has never been evaluated against metformin. Like GLP-1 and every other insulin in the world Afrezza has been evaluated for cases where oral meds including metformin have failed, and like all those other injectables it was superior. No surprise. I believe that buying V-Go was about buying a revenue stream and a salesforce, nothing more. Nobody could have expected to turn around V-Go after two companies had tried and failed. It did make the books and story better however at a time when that was needed.
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Post by agedhippie on May 9, 2024 13:28:27 GMT -5
If I was Mike I would be starting a safety clinical trial against RAAs. Let’s go ahead and get the safety superiority designation against RAAs. No risk of insulin-derived amyloidosis, lipohypertrophy, weight gain, pain, needle phobia, inconvenience, and so on. Compare prevalence in hypoglycemia and post prandial hyperglycemia. All patients wear CGMs. It would be a clinical trial like no other, assessing injection sites before and at the end of the trial for insulin-amyloid prevalence from RRA usage and lipohypertrophy, this of course would involve knowledgeable dermatologists and endos in this field of research which is small. Requires special testing and is invasive. While we are at it, let’s do a large scale trial against all the oral antiglycemic agents for TIR superiority. Afrezza will blow this study out of the water. Go ahead and add on the gestational study that Mike has been talking about and we have a hell of a 3 studies to work with. The first two are not going to happen. The outcomes you are looking at take years to decades to develop, needle phobia is a tiny group, inconvenience exists with both options, and hypos are better but marginally so for Type 1. For the second trial they would still stick with HbA1c rather than TIR because the TIR outcomes data is not as well developed (but it's getting there). The gestational study would be on the same scale as the pediatric trial since it is a class of patient. I said back in 2017 that was the trial to do, and I still do. This is an easy win.
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Post by agedhippie on May 6, 2024 22:15:48 GMT -5
Anyone else wondering why there's such a delay from the FDA with Yutrepia? It's because LQDA didn't split PAH and PH-ILD. That means approval is hung up on whether UTHR get an injunction for PH-ILD or not. The hearing for the injunction was last week so there may be a ruling this week. My feeling is that UTHR will not get the injunction, but if they do UTHR will have to file a bond for damages (probably $200M at a guess) to be paid to LQDA if the "327 patent is invalidated. There is a separate case with UTHR suing the FDA but I don't think that goes anywhere. The judge told them that they cannot sue on a hypothetical so they will have to wait for the FDA to approve and then sue the FDA.
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Post by agedhippie on May 6, 2024 10:13:20 GMT -5
The thing with the SoC is that there is no single solution. The important thing is that Afrezza has been listed as an option alongside the other options. The SoC has never specified a single treatment because people are different and what works for one person may not work for another.
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Post by agedhippie on May 5, 2024 8:53:53 GMT -5
Bid 110.977, Ask $111.662 I’ve never bought a bond before, but my memory is they typically sell for $1000 per bond. If the conversion price is $6.77 per share, then I assume 1 bond is worth ~150 (147+) shares of MNKD. If the bond holders wanted MNKD shares, they’d be better off getting paid now and buying more than 150 shares for every bond they held. I don’t think the bond holders want to go long MNKD. Regardless, that’s not in the cards because of the conversion terms. What is interesting to me is if those bonds originally cost $1000 each, and now are discounted to ~$112, there would be a huge incentive to buy them back and retire them that way. It would cost a fraction of what it will take at maturity. Couple things to observe there are not all of the bonds may be available for buyback, and buying up the bonds would presumably erode the discount. If the bonds originally sold at $100 each, then they would be selling at a premium with a bid of $110, but that doesn’t seem likely given the interest on the bonds relative to current interest rates. Therefore the bonds should be discounted, although I wouldn’t have guessed almost 90%. Pretty sure I’m missing part of the picture. Interesting stuff to be sure! They were priced at $100 each. The premium is because they have a redemption pattern similar to options so they have an intrinsic value. I feel in this case MNKD is in the position of the option writer.
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