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Post by agedhippie on May 23, 2023 17:22:45 GMT -5
... The protocol is not the issue. Its about the dosing. If they properly dosed its very possible and would be expected. ... If the PWD on afrezza goes to bed at 100 and they have not taken afrezza for 1 1/2 hours there is a damn good chance they are not going to be at 180 let alone 200. ... I would hope so. If the reps were not doing this they would not be doing their jobs. ... Dosing is part of the protocol, it's right there in the filing. If what you say about numbers at bed time for an Afrezza user is correct then the basal numbers will be a wash and have minimal impact on TIR. I seriously doubt pump sales reps see MDI as competition. People who want pumps are not interested in MDI. I don't think you know how pump reps sell because it's basically order taking and not real selling - the endo already knows which pumps they want (in my endo's group it's Tandem Control-IQ and Omnipod 5, they avoid Medtronics.) The problem remains; Afrezza is not judged in isolation and if it wants to compete with the AID pumps it needs Afrezza + basal to have the same sort of TIR.
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Post by agedhippie on May 23, 2023 8:27:47 GMT -5
First you have to define TIR. Its typically assumed to be 70-180 24hrs. A non-diabetic will seldom have excursions over 140 let alone 180 and not go below 80. So the simple answer is 100% for a non-diabetic. If what you are trying to box is a prandial insulin which is done working in 1 1/2 hours does it make sense to include that time period when you are sleeping? Of course it does not but then afrezza will have an unfair advantage and guys like Aged won't like that. Then again should the upper range be 180? Why not 160? Again 160 would give afrezza an unfair advantage. The bottom line is the video I posted earlier. Kids don't want to wear pumps. The CGM is bad enough. Kids don't want to take shots. The video says it best. The answer for TIR is already in the pilot study Kendall did a few years ago. The pump switch study will nail it. Afrezza kicks ass during the waking hours and the basal is not as good as an AID pump when people are sleeping. There won't be anything new from any of the studies. The only new info will be coming from icodec and the India study if they really did properly dose afrezza for the T2s. Mike thinks 1.5-2% A1c reduction. Thats huge for T2s. If Mike can then take that to the Medicare world and get the CGM vendors on board to push afrezza, it would be a game changer for sales. For icodec, if they really have a once weekly basal and its even close in TIR to Tresiba and afrezza, Aged's endo might be looking for a new job. During the day nothing will beat afrezza for TIR. Its from 10pm until 8am which is the question. Then again, if icodec is good enough, who cares. If you wake up at 200 take a puff of afrezza. Do you know who cares? Yes, the sales reps for the pumps who are telling endo's Mannkind is discontinuing afrezza and its going away. Next stop, afrezza/GLP1 study. Hopefully Mike announces this and some India numbers at ADA2023. Lets have a look at this... First we get the old chestnut - it's unfair to Afrezza to use TIR because half of that time you are asleep. The problem with this argument is that diabetes treatment is made up of several components to produce a result, your TIR. It's like having a nice shiny Ferrari with the wheels off a bicycle and trying to corner at speed - suddenly it doesn't look such a bargain! In the real world endos want TIR, not just TIR during certain times of the day, and without that they are going to politely decline the bargain. Kids don't want pumps. Absolutely, nor do they want anything to do with diabetes that will make them different (or indeed with diabetes at all!) I love the idea that waking up at 200 is not a problem. If you wake up at 200 (as a Type 1 anyway) you are going to feel it compared with waking at 100. Do you have evidence that pump sales reps are saying Afrezza is going away? That would be surprising because they compete with each other and not MDI. The move to pumps is driven by the endos like Steve Edelman who is an AID pump user and see the minimal effort and TIR as compelling. Certainly none of the endos in the hospital group I use think Afrezza is going away and they are one of the largest in NYC. My expectation is that the India results will mirror the 175 trial results since the protocol is literally identical. All Cipla needs is a pass, they don't need superiority.
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Post by agedhippie on May 22, 2023 17:55:30 GMT -5
The problem is that right now there is nothing to persuade endos that Afrezza is a better approach. The definitive trial are still the original Phase 3 trials, everything else is just studies. It's good that she could get a 6.5 A1c, but what the endos want to know is if that success can scale (there are people who manage similar A1c numbers with good TIR using pens but as we know, that doesn't scale.) The advantage pumps have is there is a ton of data on their performance and they seem to be able to reliably hit around 75% TIR (Omnipod 5 trial data, and the Medtronics 780G real world data for 4000+ people). Afrezza needs to meet that number to be seen as an alternative rather than an add-on or a secondary choice by endos. Its not a study or trial issue - what she said was "I’m getting frustrated when my dr says she thinks it will go away and everyone should be on a pump 🙄 funny she’s in the same hospital system doing the trial for less". The sales reps are telling the doctors afrezza is going away. Its the same tactic they used when afrezza first hit the market. Now they are trying to get in front of the kids study. The last thing they want is stories like this. www.news5cleveland.com/news/local-news/oh-cuyahoga/how-inhalable-insulin-is-helping-an-olmsted-falls-high-school-senior?fbclid=IwAR0nrdx2H02D7bm41wFW1uxS8cp2YboHA2J90y2VV32N_nYtWGOh6KO_1jkI am surprised any endo thinks Afrezza is going away at this point, certainly none of the endos in the hospital group I deal with think that. They are all heavily onboard with the automated delivery pumps though because the pumps keep people in range so well with minimal effort. Eight years ago when Afrezza launched it was competing with MDI, dumb pumps, and with CGMs still hard to get and TIR was in the mid 50% range. These days the focus is on automated delivery of insulin with minimal human intervention giving TIR over 70% which a long way over where we were. That's why endos push AID pumps. Interestingly a dumb pump + CGM is only marginally better than MDI + CGM so they used to push you but not that hard, but the AID pump is so much better that they are really pushing hard now (from personal experience - I am still on MDI so I am on the receiving end of this.) As far as the kids study goes I can see the endos trying Afrezza with a few kids whose parents want it, and then waiting to see how they do over a year or two (answering what happens over the long term.) Endos don't really care about stories like that video because they are anecdotes, they care about trial data like the pediatrics trial. Afrezza needs to average a TIR of at least 70%, and around the mid 70% range to be truly competitive which should be possible with proper dosing.
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Post by agedhippie on May 22, 2023 14:55:50 GMT -5
The problem is that right now there is nothing to persuade endos that Afrezza is a better approach. The definitive trial are still the original Phase 3 trials, everything else is just studies. It's good that she could get a 6.5 A1c, but what the endos want to know is if that success can scale (there are people who manage similar A1c numbers with good TIR using pens but as we know, that doesn't scale.) The advantage pumps have is there is a ton of data on their performance and they seem to be able to reliably hit around 75% TIR (Omnipod 5 trial data, and the Medtronics 780G real world data for 4000+ people). Afrezza needs to meet that number to be seen as an alternative rather than an add-on or a secondary choice by endos.
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Post by agedhippie on May 19, 2023 18:34:34 GMT -5
... I'm not very trusting so I am inclined to believe that the financial industry is rife with corruption and players who lobby lawmakers and work directly with regulators to ensure they have the wiggle room they need to hide their illegal activities. It's an interesting thing. In the US, I assume the IRS is sure they're being stiffed by money-laundering, while the SEC is staffed with industry insiders who are unconvinced, unconcerned, and unmotivated to do much to stop Business As Usual. I think your lack of trust is fully justified. The only thing I would say is that the lobbyists by and large are there to stop dubious activities being made illegal in the first place rather than hiding illegal activities. The problem for both the SEC and IRS is that they are very poorly paid jobs compared with industry, but a great starting point for a career in a consultancy. If you want these departments to function as we would all wish then you have to pay the going rate - and that's politically unacceptable so here we are. A lot of these people are idealist and would work for the agencies through choice, but in the end they need to make a living rather than scrape by.
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Post by agedhippie on May 19, 2023 18:23:10 GMT -5
Aged - I'm not expert enough to know, but my gut is telling me that Share holders are being SCREWED right now from this Darkpool of Naked Shorts munipulating stock price at MNKD. Here are a couple guys trying to bring light and correct this from happening and all you can do is mock it ! Please enlighten us and share with us what you have been doing to even out stock munipiulation and darkpool trading. To be clear I am not mocking, I am criticizing. That video is flat out bad and the sections I quoted show they have a total lack of understanding how those systems work. You are entitle to your gut feelings, however in reality there is no evidence that shareholders are being screwed right now. The problem for the MNKD share price is that MNKD is so tightly tied to UTHR and Tyvaso-DPI for profitability. If UTHR drops so does MNKD and right now while XBI is up 2.1% YTD UTHR is down 21%. I am doing absolutely nothing to even out share manipulation or dark pool trading. In the first case I lack the financial resources (but if someone wants to pay me a couple of million a year plus expenses i will get right on it). In the second case dark pools are systemic at this point and with few exceptions if you are a retail investor that's where your trades are happening because selling deal flow is how free stock trades are funded (for the record I use a broker that doesn't sell deal flow.) Likewise if you own mutual funds, ETFs, or have a pension you are supporting dark pools.
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Post by agedhippie on May 19, 2023 16:24:56 GMT -5
That is probably one of the worst videos on that topic I have watched. In the space of 5 minutes starting at 30:00 they completely misunderstanding the function of DTCC (it's to clear all exchanges of US equities regardless of venue so it sees foreign and dark pool transactions). Then they mischaracterize the role of FINRA which is not regulate broker dealers globally, it's to regulate US broker dealers so expecting FINRA to report on the actions of foreign brokers is stupid (we see shares move offshore and then FINRA says they don't report on those shares - of course not, they are not in FINRA's remit)
As an aside; a complaint of the alternate venues like ETNs and dark pools is that DTCC sells their trade records. If you want to see what foreign brokers are doing that's where you look, not FINRA. I suggest these people buy a feed from DTCC if they want to see who is doing what.
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Post by agedhippie on May 19, 2023 10:43:38 GMT -5
I can't get to it because of the paywall (I draw the line at giving Seeking Alpha money) but there is an article by Chris DeMuth Jr who is an analyst I follow and who has made me a decent amount of money over the years (https://seekingalpha.com/article/4605439-anticompetitive-behavior-at-united-therapeutics-regeneron-and-the-ftc). As far as I can tell it relates to UTHR and LQDA.
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Post by agedhippie on May 19, 2023 9:08:12 GMT -5
Shorting Mannkind at this point just seems pointless in everyway. After the Sanofi deal and the endless litany of illegal wall street deals that end up in court I rule nothing out but do not believe shorting is any longer an issue. I dont believe for a moment that BP is ignoring Afrezza and one way or another will be back to get a piece of it. When you cant beat um join um! I don't think BP is ignoring Afrezza, I just don't think that they currently see it as a threat with the current market share to care about right now. They have more pressing issues like the GLP-1 wars which are 2 to 3 times the revenue of the insulin lines with far larger margins.
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Post by agedhippie on May 18, 2023 21:58:09 GMT -5
I don't quite share the opinion that all corporations operate above the law. And, it might not be big pharma insulin companies (alone or at all or directly), how about vial,syringe, and bg strip manufacturers. There are many companies and stakeholders that stand to lose share and value to mnkd. They may be motivated to not make it easy. Otherwise, what maintains to be the rational case for shorting MNKD? The large corps don't do this because they have rigid processes that prevent this. Small companies have more scope because they don't usually have the controls and oversight that the major companies do. Vial and syringe manufacturers don't care (leaving aside that nobody really uses syringes for insulin any more) because they are non-specific volume products - they can be used for anything rather than just insulin. Strip manufacturers? They are far more concerned about CGMs. What is the motivation for shorting Mannkind? First you seem to be making the assumption that these people are long term shorts. Frankly at this point that's unlikely outside complex positions where Afrezza is incidental.(inverse indexes being the obvious case). It's far more likely is that what you are seeing is traders who take a short position when the share price hit's a resistance line and ride the price back down to either the mean or the lower resistance line where they exit - rinse/repeat. Mannkind is a high beta stock with decent volume so it's ideal for that trade. It's nothing personal, they are just riding the wave.
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Post by agedhippie on May 18, 2023 21:45:10 GMT -5
What exactly will the lawsuits be for? Having the best prandial diabetes solution? We even have Mike now saying the A1c GLP1 reduction period is about 2 years. Finally he is moving forward with the afrezza/GLP1 study. This time last year he didn't want to touch doing that study with a 10ft pole. What would the lawsuits be for? Patent infringements. Look at UTHR if you want to see how to do this, their play with LQDA was textbook. The patents don't even need to survive review, it's all about sidelining the competition.
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Post by agedhippie on May 18, 2023 16:18:07 GMT -5
Saw on stocktwits someone questioning the "rational case," for shorting MNKD. Then they postulated many elements of the bull case. Absent a rational case, consider the irrational - meaning, the shorts are (anti) competitively motivated, corporately funded, not profit driven, therefore willing to lose 100% of their investment, because they're not playing with their own money, and the goal is not profit but delay and destruction (of value). Just a hypothesis. Those $10 Billion insulin behemoths stand to lose a billion a year in market share to us so what’s to stop them spending a hundred mil over the years tossing shares back and forth between houses to stall or kill us? It’s not outrageous to consider. I seriously doubt they see Afrezza as a threat. Last month Afrezza bought in $7.94 Million, Lilly and Novo Nordisk bought in $1.1 Billion on just their old gen RAA insulins. Right now, eight years after launch, Afrezza sells less than the monthly sales fluctuation of either of those two. If you are a big pharma you don't mess with a competitor's stock, that's illegal and leads to bad things for the aggressor. No, you do what UTHR is doing to LQDA - you tie your competitor up in court with worthless suits because that buys you time to have a clear run at the market, this is legal and far more effective. You will know that the big pharmas see Mannkind as a threat when they start filing lawsuits.
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Post by agedhippie on May 18, 2023 14:51:54 GMT -5
Saw on stocktwits someone questioning the "rational case," for shorting MNKD. Then they postulated many elements of the bull case. Absent a rational case, consider the irrational - meaning, the shorts are (anti) competitively motivated, corporately funded, not profit driven, therefore willing to lose 100% of their investment, because they're not playing with their own money, and the goal is not profit but delay and destruction (of value). Just a hypothesis. An excellent example of why I never read stocktwits.
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Post by agedhippie on May 17, 2023 21:58:36 GMT -5
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Post by agedhippie on May 17, 2023 21:49:42 GMT -5
Is uthr packaging or manufacturing… we’re does united get the know how to produce Technosphere insulin is comprised of recombinant human insulin, a novel excipient fumaryl diketopiperazine (FDKP), the MannKind proprietary excipient and primary component of Technosphere, and polysorbate 80 (PS80). Mike long ago said it was difficult.. and that the Chinese would have one hell of a time knocking it off. Is mnkd obliged to get there production going MNKD will do all the production at the UTHR facility. It is in the contract is my understanding. Mannkind will do the production in the Danbury plant,. However, when UTHR builds a plant they will also run production there. Mannkind will assist UTHR in setting up the plant and production for no cost - those are the contract terms.
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