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Post by agedhippie on Dec 27, 2023 16:12:05 GMT -5
... I think the current gold standard is Mounjaro with 90% of people taking Mounjaro 10-mg plus basal insulin achieved an A1C of under 7% when with an average starting A1C of 7.9% to 8.6%. If afrezza without a GLP1 and without a basal can show 1.5 - 2.0 A1c reduction that should be the new gold standard. Let's look at this properly since I think that data is from Surpass-2 (NCT03987919). In Surpass-2 10mg of Mounjaro (basal insulin isn't used) plus whatever metformin they were on gave an average reduction in A1c was 2.37 so that is the target. If Afrezza can only manage 1.5 - 2.0 it's definitely not going to be the new gold standard. The clincher for endos will be that Mounjaro is a once weekly drug vs. three times a day for Afrezza. The India trial is slightly more permissive than Surpass-2 since the participants are allowed to be on two or more OAD rather than just metformin. That makes sense since it mirrors the Mannkind Type 2 clinical trial.
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Post by agedhippie on Dec 20, 2023 15:10:52 GMT -5
I was debating which thread to post in, and since this contains the most on the Federal Circuit appeal I opted for this on... The opinion was written by Judge Lourie. cafc.uscourts.gov/opinions-orders/23-1805.OPINION.12-20-2023_2241699.pdfThe whole of the case turned on the prior art argument and reading through the opinion from the court was an interesting exercise. The new material argument (was the prior art material even admissible) was turned down. All that was required was that the board didn't abuse their discretion in accepting the material, which the court found they hadn't because it was introduced in respond to new arguments made in a patent owner response. The next point was the interesting one; that the prior art material hadn't reached the level of public distribution. This was the key argument because if UTHR won it for either the JESC, and JAHA or abstract books then the previous admissibility point was irrelevant. Remember Reyna was asking why LQDA couldn't even produce one person to say they had received it. The LQDA lawyer pointed out at the hearing that they were not obliged to (which is true). The opinion pretty much took that line and ran with it listing the ways which the UTHR had got this wrong (pages 8 and 9 for those who want entertainment). On the obviousness argument the court seems to have taken the view that not even UTHR believed this ("This argument, only a single paragraph in UTC’s opening brief, borders on waiver.") The final point, dosing had two problems; UTHR hadn't raised it before the PTAB and so was forfeit, and that even if it had been permitted it would have failed the obviousness test. At the point this was originally argued before the PTAB UTHR had relying on the prior art argument failing and this came back to haunt them as the allowed the LQDA expert's testimony that a person of ordinary skill in the art would have had a reasonable expectation of success in arriving at the claimed dry powder formulation based on the combined teachings of the ’212 patent, JESC, and JAHA. If either of JESC or JAHA had not been accepted as prior art that strategy would have worked.
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Post by agedhippie on Dec 17, 2023 4:57:21 GMT -5
How do people keep forgetting facts like “less than one quarter’s worth of operating capital” (situation in 2017 when MC took over), and COVID lockdowns? MannKind was nearly bankrupt. If memory serves, they just reported positive EPS for the first time in 11 years (or more). MC inherited a drug needing to be re-launched (which on average has a low probability of success) and a company that had just completed a 1:5 reverse split, had been placed on the SHO list by the SEC, was nearly delisted from NASDAQ, was suffering under a mountain of “toxic debt”, and had only a small salesforce at best. I mean come on for Pete’s sake. ... When a company runs out of money and can no longer borrow then it sells the family silver, and that's what Mike did. There is nothing smart or clever about this, it's what any 101 level business course will tell you to do - when listed companies run out of money they take it from the shareholders via dilution. Mike was hired not as the CEO but as CMO to relaunch Afrezza, a task he has failed at so far. Along the way we have had a string of failed marketing schemes, a brief forays into epi-pens and covid vaccines, and finally Martine saves MNKD. With Afrezza Mike failed to understand the basic truth of the insulin market; insulin is a market that is gate kept by the endos. Direct to consumer marketing (flying burgers!) does not work as it does with many other drugs. What those endos want is hard outcomes data to provide justification for moving patients to Afrezza and that was never done. Instead we have an overpriced insulin with poor insurance cover whose sales are less than Humalogs week to week sales fluctuations. Usually at this point people start saying I want Afrezza to fail. Nothing is further from the truth. I want diabetics to have the maximum number of choices and Afrezza is the only inhaled option. I also happen to think that a proper clinical trial with the correct dosing regime could actually show those outcomes that have been lacking to date and that endos need. But we are nowhere on that. No, Afrezza isn't for everyone and I wouldn't want to use it because it looks to be to high touch for me, but there is a market who would love this option.
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Post by agedhippie on Dec 16, 2023 12:29:24 GMT -5
For now but I think he has a fighting chance to win the appeal. This was a civil case not criminal and now that they went after him for his software company Druglike, it seems clear the ban was too broad. www.bloomberg.com/news/articles/2023-12-14/-pharma-bro-says-industry-ban-may-keep-him-from-drug-store-jobBTW - What say would Mike have? I am not talking about Martin working for Mike. I am talking about who can get the pps to $30+ and if history tells us anything its not Mike. Lets get serious about MNKD's reputation. For years BP has been going around telling doctors MNKD is going bankrupt. Suspend disbelief about some of Martin's past and current ban - who would have a better chance of moving the pps to $30 in one year - Mike or Martin? Here is what we know. The MNKD pps is down about 25% this year after turning a profit and at the same time Mike just sells 100k shares. I suspect its for the divorce settlement but if assets are being split 50/50 he is going to need to sell another 1M share. Do the shareholders need that pain and that distraction while at the same time the company is not performing? I doubt he wins that appeal. He has no qualification or experience in the pharma business beyond buying drug companies and hiking their drug prices. His qualifications, such as they are, are all in finance so not being able to be employed in pharma is no obstacle to his employment. ... because nothing says reputable drug like being promoted by a convicted felon known for manipulating drug prices and defrauding people. Nobody is going to suspend disbelief, although they may get a good laugh at MNKD's expense. Seriously, this is beyond stupid at so many levels. The shares are Mike's to sell and he doesn't owe anyone an explanation. If you pay people in RSUs then they will need to sell from time to time.
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Post by agedhippie on Dec 15, 2023 15:10:02 GMT -5
... One thing I do know is Martin could get a ton of earned advertising and if it was spun correctly it could be presented as his redemption tour as "bad boy turns good" and he is now promoting the greatest advance in diabetes care and has a near cure to T2 diabetes which could save $100Bs in medical costs. ... Martin Shkreli has a life time ban in the pharma industry from one of his many prosecutions so it would be suicide for him. That's before we even look at the impression having him shilling for you would have on your company's reputation in the medical world. Most companies would pay for that not to happen because they aren't stupid, I don't think even Mike would go there.
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Post by agedhippie on Dec 15, 2023 4:35:30 GMT -5
Interesting. LQDA getting bad news? LQDA just raised $25M @ $7.12 (announced Dec 12th, closed Dec 14th) so that was the dilution hitting. It was a clean raise with no warrants or discounts, and insiders bought almost half of it.
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Post by agedhippie on Dec 15, 2023 4:28:41 GMT -5
RSUs are typically form part of your salary and as such the advice you get is always sell them unless you would buy the stock if someone handed you the equivalent amount of cash. Companies like paying people in RSUs because the shareholders pay via dilution rather than a cost to the company reducing P&L. Personally, I generally keep stock from RSUs if I can live on the cash component and I think the stock will do well in the long term - but that's personal and I didn't need the cash at the time.
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Post by agedhippie on Dec 12, 2023 11:14:49 GMT -5
Ah. An insurer will allow the employer to select whatever drugs they want if they are self insuring. For example EmblemHealth is administering HIP and GHI for the NYC government. If you look at the Medicare plans available in New York to the public you will see that Afrezza is not an option for them (neither is CIGNA who owns Express Scripts). The Express Scripts formulary is not a final version because it's dated August. This site shows the definitive version for public plans because it is the government site all insurers have to go to for approval. They cannot change their plans without approval so the site is always accurate. Put in 10001 as the post code if you want NYC. www.medicare.gov/plan-compare/#/?year=2024&lang=en
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Post by agedhippie on Dec 12, 2023 7:41:57 GMT -5
thanks i have done just that (with someone elses postcode as i live in the UK). I was worried it was going to be dropped altogether, so happy to see its still there albeit tier 3. ... Who was covering it at tier 3?
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Post by agedhippie on Dec 12, 2023 6:29:21 GMT -5
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Post by agedhippie on Dec 12, 2023 6:05:28 GMT -5
I think this was discussed earlier in the Medicare Part D thread. It is a knock-on from the $35 insulin cap with Medicare. The issue is that Afrezza is an order of magnitude more expensive than RAA and the insurer can no-longer recover that cost via rebates and co-pays for Medicare plans. If the insurer drops Afrezza from their Medicare formulary but leaves it in their commercial plan formulary then there are going to be questions about why it is one plan and not the other. It's far simpler all around to drop it from all plans which they can do since it is classed with meal time insulins and there are alternatives.
You can file for a formulary exception, but if you do that you are paying the full price as the cap only covers the formulary. TBH, if I was in this position I would jump to the $99 offer and bite the bullet on cost which while expensive is less expensive than the alternative via insurance.
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Post by agedhippie on Dec 11, 2023 18:27:59 GMT -5
I think Mike and team have not been doing a very good job influencing the SoC. Maybe next year? Table 9.4 alone demonstrates why no doctor is going to prescribe afrezza. It is nearly 10x other alternatives and nearly 4x the next most costly insulin option. No one from MNKD told them they can get it for $99 A MONTH with no coupon. ... The problem you hit with 9.4 is that A at the end of the line. That A is the evidence category and A is as high as you can score. To do that there have to be multiple large scale trials with demonstrably superior outcomes. The pump manufacturers have done the work to produce the evidence, Mannkind hasn't and what you see is the result. This has nothing to do with cost (have you seen the price of a Medtronic pump?) and everything to do with trial data.
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Post by agedhippie on Dec 10, 2023 3:17:20 GMT -5
The school nurses and Trained Diabetes Personnel (TDP) could also benefit from a demonstration (using BlueHale??) and some information about dosing and administration. I wonder if there are placebo cartridges for demonstrations? A demo would be good and could be justified as ensuring that the doctor's orders are correctly followed. I would frame it as being the same as teaching correct injecting technique. Dosing and administration would be off-limits though as that is prescribed in the plan by the doctor. The nurse is not allowed to stray off the plan since they are there to administer the it and not to modify it which would be the doctor's role.
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Post by agedhippie on Dec 10, 2023 3:10:54 GMT -5
... The doctor prescribes. That's a given regardless of whether they prescribe Afrezza or Humalog. Schools can say, " we prefer the doctor prescribe Afrezza because of the SAFETY and reduced likelihood of hypoglycemia". ... Presently the doctor would then likely say that there is no clinical trails showing superior outcomes and that the kids insurance doesn't cover Afrezza. Of course that part you've stated about meaningfully superior results on peds trial being a game changer is probably the key. That would change physicians views and insurance coverage. TBH none of that matters because there is absolutely no way the school would ever express an opinion on a drug because of the liability risk. If they were insane enough to actually do it and you went back to the endo and asked them to change the treatment they prescribed based on the advice of a school nurse it would not end well.
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Post by agedhippie on Dec 9, 2023 12:14:17 GMT -5
Maybe that’s the ticket. “We’d like to meet for dinner and discuss why the Section 504 Plan in the state/district would benefit from some minor modifications to include support for our inhalable insulin.” They would probably just ask you to send them the proposed amendment and justification. I cannot see it being a fight. Interestingly section 504 gets quite unclear once you get to religious and private schools. This is a topic of some heartburn to campaigners. There is still the Americans with Disabilities Act to fall back on in those cases though, but it requires a lawsuit.
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