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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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Post by agedhippie on May 5, 2024 0:01:20 GMT -5
Not entirely true "Upon conversion, the Company will pay or deliver, as the case may be, cash, shares of the common stock or a combination of cash and shares of common stock, at the Company’s election, in the manner and subject to the terms and conditions provided in the Indenture." I agree that the debt will be converted if it is above the 6.77 price for 19 day otherwise the debt holders will loose out on some cash. Best bet for MNKD would be to buy back the bonds on the open market when they are trading at below face value. US56400PAQ54 if someone wants to look at how the bonds are trading. Bid 110.977, Ask $111.662
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Post by agedhippie on May 4, 2024 13:00:48 GMT -5
I wasn’t suggesting MannKind try to claim SAFETY differentiation based on existing trial data. I assumed it would or might require a safety trial. And I’m not overly anxious about this because I’m no longer overly concerned about Afrezza sales. I do think a safety trial would be a good next step to improve the marketability of Afrezza. In that case yes. An easy way to do this would be to collect existing CGM data from Afrezza users, pool it and compare that with a pool of CGM users using RAA. The pools would need to be big to avoid bias, but in principle you could do it purely off analysis. This would be relatively quick provided (a big if) you could get the CGM data. This is what Medtronic did recently with data from their 780G AID pumps although in their case it was easier because they already had all the data.
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Post by agedhippie on May 4, 2024 11:33:45 GMT -5
How’s it illegal ? It’s and FDA approved drug not being used off label. Now that we know SOC IS SUBJECTIVE BS . It’s just business! Incentives are fair game . Illegal is being lazy and not giving what’s best. You cannot incentivize doctors to prescribe a drug. This may be my fault, but that's what I thought you meant by entice.
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Post by agedhippie on May 4, 2024 10:37:24 GMT -5
100% disagree, I think. I’m not saying that MannKind should storm into ADA and claim everyone there are liars and sue their industry association. I’m saying do what can be done with what’s been learned, but maybe just to Hell with “superiority”. If MannKind can prove “superiority” of Afrezza prandial insulin over other alternitives, cool, do it. But if that’s really, really hard, then so what? Beat the competition on SAFETY!!! Think about it. What is it doctors are taught about prescribing insulin? Be afraid! Be very very afraid! SAFETY (SAFETY, SAFETY,...) has VALUE. I’m an investor, but I believe MannKind’s Afrezza is head and shoulders above the competition when it comes to SAFETY with respect to hypoglycemia. The problem with the safety argument for Type 1 is that the Phase 3 trial found that while the reduction in hypoglycemia was greater in absolute terms it was not statistically significant so it cannot be claimed. MNKD published a correction to their original release for this - investors.mannkindcorp.com/news-releases/news-release-details/correcting-and-replacing-mannkind-reports-positive-data-phase-3. That is not to say that I personally think you won't have few hypos with Afrezza, it's just that you cannot prove it. To explain this; what they are looking at is the number of participants who had hypos, and then the difference between the two compared to the number of participants. Since the number having hypos is small the difference between the two will be even smaller meaning that relative to the total number of participants it falls within the margin of error. Statistical significance matters because it tells you where you should care or if it might just be noise.
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Post by agedhippie on May 4, 2024 9:31:20 GMT -5
The SoC does not dictate insurance coverage or would all have been using CGMs years ago. The insurers have their own panels who decide if an item should be covered (or more accurately justify why coverage should be restricted.) ... What about lawyers making a case against the insurers? Has MNKD presented enough data to bolster the argument that it deserves the same or equal to the coverage other insulins receive and Insurers are failing to make the comparison and same conclusion? What is their case to defend their decision..."Other options are available that already address that need?" Well, that is the basis for MNKDs argument...it's the same as what is already covered but an inhaled form. Seems the first step is to get the coverage..then, later, say we are better. The insurers will point at their panel and say that the panel has evaluated the evidence. The panel will say that the only meaningful evidence they have at this time is the Phase 3 trial from ten years ago where Afrezza was non-inferior and therefore equivalent. The form of the drug (inhaled, injected, or oral) is irrelevant to the outcome and therefore has a low weight. Seriously, this is on MNKD. The Phase 3 trial is there to see if the drug works at scale and at least matches what is already there. This is why there are post-approval trials to improve the label, but MNKD did not do those. Trial data is everything in this world and INHALE-1 is a step in the right direction. The problem for MNKD is that the only evidence they have for Type 1 that is fit for purpose is the original phase 3 trial. Since then it's just been small scale studies and those will not have any influence with the panel. The INHALE-1 trial is the first trial or study since that phase 3 trial ten years ago that a panel would look at.
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Post by agedhippie on May 3, 2024 19:16:51 GMT -5
So it seems to me the physicians probably don’t want to deal with the learning curve of AFREZZA , and baby sitting a good portion of the patient’s But a question I have after all this time / is there any financial benefit/ incentive doing it the more cumbersome way with AFREZZA ( follow the money) can something be done to entice them to prescribe or is that unethical… subjective… I guess ..but the world we live in . Never mind unethical that's illegal!
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Post by agedhippie on May 3, 2024 19:07:28 GMT -5
... Ages tells us its a voluntary guide which is kind-of but not really true. More important it dictates insurance coverage. With Inhale-1,2 and 3 we can fix the label. With Inhale-1,2 and 3 I would hope we can make some progress with the SoC. To fix the cost we have to fix the insurance coverage which will only change when the SoC changes. The SoC does not dictate insurance coverage or would all have been using CGMs years ago. The insurers have their own panels who decide if an item should be covered (or more accurately justify why coverage should be restricted.) And INHALE-2 was published 10 years ago. If that was going to change the SoC it would have done so by now!
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Post by agedhippie on May 3, 2024 15:19:00 GMT -5
So at the end of the day standard of care is all BS too ..semantics When will it end ? Basically yes (IMHO), it is really about deskilling. The SoC enables a doctor who doesn't cover the area to have a guide to the consensus amongst doctors who do cover the area when he treats someone. If you get an endo who knows what they are doing they will deviate from the SoC where they think they can do better. A case in point was my old endo who had lots of Type 1s on metformin when the SoC explicitly said not to do that. I suspect that VDex deviate from the SoC as well because they know what they are doing. In the immortal words of Pirates of the Caribbean, "The code is more what you'd call 'guidelines' than actual rules."
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Post by agedhippie on May 3, 2024 13:01:57 GMT -5
If this is accurate does being part of the SoC imply insurance coverage will follow? No, it's been in the SoC for a while. You can find it in section 9 of the SoC as inhaled insulin.
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Post by agedhippie on May 3, 2024 12:52:37 GMT -5
Afrezza is the only inhaled insulin on the market! ADA barely recognizes it ever, especially in the SoC. Look who funds the ADA-BIG PHARMA. MannKind is not one of the funders. There's also a financial disclosure attached to these things. There's more to it than that too. The SoC is a bias consensus. It's a disservice to PWDs for ADA to pretend Afrezza doesn't exist. It's the safest mealtime insulin option available, and when people get it dialed in they have fantastic results. Low risk for hypos, no insulin derived amyloidosis, no lipohypertropthy, no mealtime needle sticks. Safe and effective. I've said before ADA should be sued and investigated, maybe that really needs to happen. I'm with SayHey here on this one. Suing the ADA is not an option because it is a non-governmental entity providing advice that everyone is at perfect liberty to ignore it (my old endo did!) The fact that people find it persuasive and don't widely ignore it is not grounds for a lawsuit, it's grounds for education. If you tried to sue the judge would tell you that you cannot compel a private entity to accept your point of view.
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Post by agedhippie on May 3, 2024 11:00:42 GMT -5
... Now, its the CEO's job to hire the right lawyers to get afrezza as standard of care in the ADA's Standard of Care. ... We need great lawyers representing us with the ADA Lawyers? You really don't understand how this works do you! What would be their case as a matter of curiosity?
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Post by agedhippie on May 3, 2024 10:57:25 GMT -5
Read what I say, not what you think I said. Once more and slowly. The 175 trial, aka. INHALE-2, establishes is that for a broad population (good) it is better to take Afrezza than not to take anything (meh). What to you want, a slogan like "Afrezza, better than not taking anything"? ... No the 175 did not do that. The PWDs continue to take there current meds including DDP4 if they were taking that. They then added afrezza or a placebo powder in the inhaler. It did what the T2 SoC treat to fail standard says to do. ... One group takes oral meds and nothing, and the other group takes oral meds and insulin. It is obvious that the insulin group does better whether that's Afrezza, RAA, or even animal insulins. Hence nobody cares about 175.
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Post by agedhippie on May 3, 2024 9:00:58 GMT -5
I don't think he was trolling (necessarily), but simply got mixed up. It happens a lot.
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Post by agedhippie on May 3, 2024 8:36:57 GMT -5
How many kids? None. Read the title of the trial and you will understand why. I can't keep up with you. For the longest time you said the 175 even though it showed superiority was not a good study because it used the placebo as the adder. Then you finally admitted it was a good study since thats the way the SoC works. Now you say we will get no movement on the SoC because we have not done enough studies. You say Inhale-1 for the kids is not enough, we need more. The Inhale-3 is not enough, I am not sure why. You said it was not for adults but it clearly is. The Inhale-2 did something and was a good size trial for the T2s and Mike said he expected a 1.5 - 2% A1C reduction. ... Read what I say, not what you think I said. Once more and slowly. The 175 trial, aka. INHALE-2, establishes is that for a broad population (good) it is better to take Afrezza than not to take anything (meh). What to you want, a slogan like "Afrezza, better than not taking anything"? This is patently trolling - The Inhale-3 is not enough, I am not sure why. You said it was not for adults but it clearly is. Look at my response to your question about how many kids there are in INHALE-3, it's easy, it's quoted in your reply (and the first quote in this reply.)
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