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Post by agedhippie on Aug 10, 2023 21:49:41 GMT -5
It was 110° there and the fire department was literally spraying people to cool them down and they were all gathered around our booth.. 😀 yay Well that should prove that Afrezza isn't temperature sensitive.
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Post by agedhippie on Aug 10, 2023 17:50:39 GMT -5
To make afrezza real and huge for the T2s all we need to do is focus on the Medicare market and make sure we don't need pre auths going forward. I will say getting the pre auths this year was a big F'ing deal and now Mike is seeing the benefit. The India study should really help if Mike's 1.5-2.0 A1c reduction is reality. Deciding if pre-auths are necessary is up to the insurer, not Medicare. The insurer must pick one drug from the class, but can optionally offer others and may require pre-auths on those. The India study had better hit 1.5-2.0 because Mounjaro beats those numbers.
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Post by agedhippie on Aug 10, 2023 17:38:40 GMT -5
.. Robert Ford has a zillion studies. The problem with CGMs and GLP1s are GLP1S do not stop the meal time spike. The CGM provides little power for GLP1s. They actually expose the GLP1s. ... Lilly has trial data for people on Mounjaro with 91.2% TIR, and 72% between 80-140 from the SURPASS-3 trial. Against that getting Afrezza to preempt GLP-1 in the Type 2 SoC is a very hard sell. Add in the cardiovascular study results from Novo Nordisk and I really cannot see it happening, it simply offers much better value.
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Post by agedhippie on Aug 10, 2023 8:17:19 GMT -5
As I said - afrezza was included in the senior saving model which ends 12/31/2023. It was started years before the IRA but because of the IRA and the $35 insulin its ending this year. Without the IRA the SSM would not be ending and afrezza would still not be selling. The SSM for Mannkind and afrezza was an epic fail. ... What in the world is he going to do with it once pre auths are no longer required for afrezza? On Monday he was still talking about "stabilizing" it. Great, now its not losing that much money and he is "hoping" its going to start growing soon. Its never going to be a growth product and with icodec coming there is not much room in the T2 market. For meal time control we already have a superior solution for the T2s. The new T2 SoC is becoming pretty clear; get the T2 on a GLP1 asap to lose some weight and reduce A1c; add the afrezza to control the meal time spikes and sell CGMs and backstop the GLP1s for when they stop using in a year; and add the icodec if the T2 is in really bad shape. Let's keep that time line straight. Mannkind sold through the SSM for only a year before the IRA kicked in so while SSM started earlier that's irrelevant to Afrezza sales. As to exactly what those sales looked like; to the best of my knowledge the impact has never been divulged but it may be in a 10Q or transcript somewhere that I have not seen (is it?) Why will pre-auths no-longer be required? The requirement is to sell formulary insulin for $35, not to eliminate pre-auth and sell for $35. Let's be clear on this - you believe that insurers will be compelled to sell Afrezza without pre-authorization, and I think that is an incorrect reading of the IRA on your part. Right now we are waiting to see if everyone has Afrezza without pre-auth in their formulary which I don't believe will happen because the IRA does not require it, not because Mike is falling down on his job. A new SoC for T2 requires data and proper trials. I have seen nothing like that out there and absent that the SoC will remain unchanged.
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Post by agedhippie on Aug 10, 2023 8:05:16 GMT -5
... For Medicare both Abbott and Dexcom want to sell CGMs but the PWD needs to take insulin. This flips the GLP1 usage a little. The real power of the CGM is with prandial insulin but what T2 wants to take injections when they can inhale and have better control? The CGM vendors don't care if the PWD takes a basal or prandial. All they care about is the PWD is using insulin. Icodec will fit the bill but whats the CGM going to tell them - most likely, they have no meal time control and need afrezza. Prandial insulin is a long way down the treatment steps so CGM makers are not going to help because by the time the patient is on a prandial insulin they are already on a basal and so eligible for a CGM. Their focus is on getting CGMs for GLP-1 users and that's where they are spending their energy. If they were going to promote an insulin it would be Icodec or similar alongside a GLP-1 because that fits the SoC. Short of a change in the SoC the idea of getting CGM makers to push Afrezza is going nowhere.
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Post by agedhippie on Aug 9, 2023 17:34:51 GMT -5
There was an interesting article on Bloomberg today looking at Novo Nordisk bemoaning the fact that they literally cannot make Ozempic/Wegovy fast enough to keep in stock. There was one other interesting point; while a monthly dose in the US costs around $900 the NHS in the UK is paying $94 per month. The component cost is around $40 apparently. This does mean that stock is diverted to the US because it's so much more profitable here.
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Post by agedhippie on Aug 9, 2023 17:23:37 GMT -5
I said don't get me started on this. This is a sore subject with me. Yes, afrezza was included in the senior saving model which ends 12/31/2023 thanks to the IRA. ... I think your timelines are muddled. The Medicare Part D Senior Savings Model had absolutely nothing to do with the IRA. Not least because it started two years prior to the IRA (Mannkind joined in the second year in March 2021 - see my earlier link) and Mannkind commenced coverage at $35 in January 2022 under that plan. The IRA only became law in August 2022 so Afrezza had already been sold for $35 under the model for eight months at that point, and continued to do so for the rest of the year when the IRA provisions kicked in. This makes it hard to say that Mike had no idea that $35 insulin was coming given that they were already selling it.
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Post by agedhippie on Aug 9, 2023 8:03:33 GMT -5
... What I do know is this time last year the idea of Medicare covering afrezza at all was not in Mike's wildest dreams and we got V-Go for the T2s. Afrezza on 2024 Medicare formularies and not needing pre auths would be huge. Medicare has covered Afrezza for years, insurers providing Medicare cover have been a lot more reluctant. It has been available to low income Medicare recipients for $35 since 2022 with Mannkind announcing this a year earlier in 2021 so I really hope Mike wasn't taken by surprise (https://investors.mannkindcorp.com/news-releases/news-release-details/mannkind-participate-2022-medicare-part-d-senior-savings-model). What we are seeing here is Medicare patients using Afrezza in the same proportion (28% of revenue) as with RAAs. It does overstate the case though because currently pediatrics are not using Afrezza whereas they are using RAA. This means the rate will probably continue to rise since the weighting is to the older end, and will revert to 28% when the pediatrics approval goes though.
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Post by agedhippie on Aug 8, 2023 17:36:37 GMT -5
Regards to INHALE-1, can someone help me understand what exactly is interim analysis and what can we expect from it in the next call? I don't know if the recording is available but I recommend listening to it if the transcript is too hard to follow. Mike mentioned more than once, and answered a question from an analyst about the "interim analysis". I'm guessing agedhippie can helpfully chime in here too.
As best as I can describe it is an "interim analysis" is a checkpoint. It's a planned waypoint to measure progress and make adjustments to the trial (including termination if necessary) such as adjusting goals, length of trial, quantity of participants, et cetera. I'm no expert on this so hopefully I'm not messing up the description too badly.
I assume making some adjustments are simple and not difficult to ingest the data from the change such as increasing the length of the trial or adding new participants, but other changes could make it difficult to assess results.
In any case, it's a planned waypoint to assess and adjust if needed/wanted.
You pretty much nailed it. You don't want to be continuing a large trial if the results are bad because you are just throwing away money. It's hard to modify a trial that's in flight, but what it can do is let you decide if you want to do an extension, or start another trial to expand a particular aspect that is showing up.
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Post by agedhippie on Aug 7, 2023 15:39:16 GMT -5
$4.87 right now...thought it would go higher given the amount they beat est. After hours is always a lottery. See how it goes in the morning, my suspicion is that it's higher.
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Post by agedhippie on Aug 7, 2023 15:37:34 GMT -5
Different drug. Think RAA vs human insulin - one is modified and the other isn't. That news article is sensationalist. The really interesting bit is that she took them for over a year. Given how bad the side effects were claimed to be my question would be why? GLP-1 analogs work by cause gastroparesis, slowing gastric emptying to make you feel full for longer, how did she miss that? And why didn't here doctor take her off it?
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Post by agedhippie on Aug 7, 2023 12:09:53 GMT -5
It's really weird that TS eliminates almost all side effects of drugs and yet it still hasn't taken off as a platform. I'm struggling to understand the logic of that. Join the club. We have seen what it did for human insulin. It pretty much made afrezza a wonder drug. We have seen what it did for Tyvaso and we never hear about "the cough" with Tyvaso DPI. Could other drugs benefit, one would think. How about Victoza? Could you imagine if TS could reduce the GI issues yet still provide the appetite suppression. Technosphere works best where when delivered orally the drug either has poor bioavailability, requires rapid transfer to the blood stream, or causes side effects. An example is nintedanib which ticks both of those boxes! An example of a drug which isn't a candidate is the GLP-1 analogs which have reasonable bioavailability, rapid transfer to the blood stream is not desirable (the need for an extended effect), and the side effects are intrinsic to the action of the drug (slowing gastric emptying) rather than the ingestion of the drug. There is a use case where uptake of the drug is impacted by the acidity of the stomach (either to much or to little) and makes certain drug combinations problematic. The issues for Technosphere are the cost of the inhaled version vs. the oral version, and that the original formulation is often good enough. The Technosphere version needs to establish superiority over the existing version or you get a repeat of Afrezza rather than Tyvaso DPI.
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Post by agedhippie on Aug 6, 2023 10:35:56 GMT -5
Or if not a collaboration with UTHR, then with the owner of nintedanib, Boehringer Ingelheim (BI). OFEV® was BI's second-strongest revenue contributor in 2022. (The first was Jardiance). 2022 net sales for OFEV® were 3.2 billion EUR, representing a currency-adjusted growth of 20.6 percent in 2022. It appears that the last of the BI patents covering OPEV expires in 2029. A license with BI might be necessary.
... They will need to move fast. There is a tentative approval for a generic version that avoids the last two patents and becomes valid after the expiry of the '093 patent in Feb 2024. The drug has been used with a nebulizer, but there is not much literature on the outcomes. The mechanism for the side effects has not been definitively pinned down, but it looks like some may be cause by inflammation from decomposition products of the drug in the gut so an inhaled form would remove that possible cause (there would still be other side effects, and that particular side effect is managed with a steroid)
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Post by agedhippie on Aug 4, 2023 8:53:50 GMT -5
Blackstone are after the free cash flow. They are getting a stake, maybe up to 60% if they exercise rights they would get from the 33% share. I don't see this will have any impact on Mannkind either way (it's just one of a pile of drugs Cipla handles). I would also not be certain this is a done deal as I can see the Indian government getting involved in this.
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Post by agedhippie on Aug 3, 2023 16:20:00 GMT -5
Great to hear your insider views. Seriously, though, in your view is CAT going to be complied with and provide actionable data? The most recent article I found was 2022 and it was another SRO (SIFMA) making additional excuses for why compliance was a problem and acknowledged yet another delay. ... It really depends on your timescale. Are you looking for problems today, one off issues, patterns, these all have different answers. You may have a bad actor who only exploits 10K releases in which case it could take years to get the data since it's an annual event. You might have someone who is trading a lot and that could be a lot quicker, they might hit a flagged stock and then it could be days. The data lake itself is in use today.
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