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Post by porkini on Jun 26, 2024 21:08:26 GMT -5
All these data points are like berries. We’re still gathering a basket of berries for our preserves. They look so sweet and tasty sitting there, we all want a spoonful I know. However, we need to gather ALL the berries needed to make jam for the FDA. Pediatric readout is the final berry patch to scour. We’ve got to cover dosage changes, label changes and safety updates. And, we have to do it convincingly enough to erase a decade of indifference to Afrezza. Not until we fill our basket, will we have enough to make the jam. Meanwhile, I think we’ve cracked the code with the right amount of medical assistance and handholding during onboarding of new patients to increase sales incrementally while we wait. Guess I’m hungry. Toast and jam it is. We be jammin… 😎 I couldn't resist... |
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Post by hellodolly on Jul 2, 2024 15:03:03 GMT -5
The last place I'm looking for investment advice is from ProBoards. With that said, we're all free to express our own opinions and I'd rather like to keep it that way, good, bad or indifferent. As to the INHALE -3 Results and PB commentary.
I think there is some truth to what H&W had to say. Take for instance the fact that Afrezza is insulin, "Repeat after me". Some condescending overtones, (reminds me of LFD, same tone, syncopation, rhythm, style, syntax, etc.) when he snaps back in the SA comments section or, tries to defend his thesis or challenges you to look for facts. When you lead him to it, crickets.
Regardless, yes, Afrezza is insulin but it has had difficulties being adopted by the mainstream KOL's, prescribers, requiring work arounds for insurance approvals, etc. I feel that this study lifts up what is under the Afrezza hood and now shows the world how it works. Now, it's not new that Afrezza is not for everyone and again, the study rather confirmed it. As Dr. M Aleppo described the one patient who opted out [paraphrase]," He had good control and managed his carb intake very well so he didn't think he needed it." That is an excellent example of this not being for everyone. But, not everyone has great control..in fact, we have seen dozens of anecdotal representations by early adopters and the most recent users all saying they had better "meal time control" or "use Afrezza to control excursions after meals". Afrezza is a the fastest acting "meal time insulin" in the world and while, yes it is insulin it is also differentiated by that little well known fact. Plus, the safety profile has been rediscovered by the KOLs in this trial. THESE facts are the story that got lost in the broader discussion.
So, while my opinion will be spun as "hopium", and the counter narrative is always spun as "balance", I'm glad I'm able to post my opinion.
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Post by sayhey24 on Jul 2, 2024 15:36:42 GMT -5
The last place I'm looking for investment advice is from ProBoards. With that said, we're all free to express our own opinions and I'd rather like to keep it that way, good, bad or indifferent. As to the INHALE -3 Results and PB commentary. I think there is some truth to what H&W had to say. Take for instance the fact that Afrezza is insulin, "Repeat after me". Some condescending overtones, (reminds me of LFD, same tone, syncopation, rhythm, style, syntax, etc.) when he snaps back in the SA comments section or, tries to defend his thesis or challenges you to look for facts. When you lead him to it, crickets. Regardless, yes, Afrezza is insulin but it has had difficulties being adopted by the mainstream KOL's, prescribers, requiring work arounds for insurance approvals, etc. I feel that this study lifts up what is under the Afrezza hood and now shows the world how it works. Now, it's not new that Afrezza is not for everyone and again, the study rather confirmed it. As Dr. M Aleppo described the one patient who opted out [paraphrase]," He had good control and managed his carb intake very well so he didn't think he needed it." That is an excellent example of this not being for everyone. But, not everyone has great control..in fact, we have seen dozens of anecdotal representations by early adopters and the most recent users all saying they had better "meal time control" or "use Afrezza to control excursions after meals". Afrezza is a the fastest acting "meal time insulin" in the world and while, yes it is insulin it is also differentiated by that little well known fact. Plus, the safety profile has been rediscovered by the KOLs in this trial. THESE facts are the story that got lost in the broader discussion. So, while my opinion will be spun as "hopium", and the counter narrative is always spun as "balance", I'm glad I'm able to post my opinion. The one surprise I saw from Inhale3 was no difference in CGM-measured hypoglycemia between the groups. That surprised me a little. I was expecting no difference in severe hypos but no difference in all hypos was surprising as I expected the basal to have a negative impact. Aside from that I think the results are what we have been saying for years on Proboards. So why has it had difficulties being adopted by the mainstream KOL's? I would think these KOL's should know a lot more about diabetes than some Proboards posters. We had already seen from the one testing center during the 171 study similar great results. So much so the FDA accused the good doctor of cheating by proper dosing. Why did it take this study? |
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Post by prcgorman2 on Jul 2, 2024 16:19:34 GMT -5
The last place I'm looking for investment advice is from ProBoards. With that said, we're all free to express our own opinions and I'd rather like to keep it that way, good, bad or indifferent. As to the INHALE -3 Results and PB commentary. I think there is some truth to what H&W had to say. Take for instance the fact that Afrezza is insulin, "Repeat after me". Some condescending overtones, (reminds me of LFD, same tone, syncopation, rhythm, style, syntax, etc.) when he snaps back in the SA comments section or, tries to defend his thesis or challenges you to look for facts. When you lead him to it, crickets. Regardless, yes, Afrezza is insulin but it has had difficulties being adopted by the mainstream KOL's, prescribers, requiring work arounds for insurance approvals, etc. I feel that this study lifts up what is under the Afrezza hood and now shows the world how it works. Now, it's not new that Afrezza is not for everyone and again, the study rather confirmed it. As Dr. M Aleppo described the one patient who opted out [paraphrase]," He had good control and managed his carb intake very well so he didn't think he needed it." That is an excellent example of this not being for everyone. But, not everyone has great control..in fact, we have seen dozens of anecdotal representations by early adopters and the most recent users all saying they had better "meal time control" or "use Afrezza to control excursions after meals". Afrezza is a the fastest acting "meal time insulin" in the world and while, yes it is insulin it is also differentiated by that little well known fact. Plus, the safety profile has been rediscovered by the KOLs in this trial. THESE facts are the story that got lost in the broader discussion. So, while my opinion will be spun as "hopium", and the counter narrative is always spun as "balance", I'm glad I'm able to post my opinion. The one surprise I saw from Inhale3 was no difference in CGM-measured hypoglycemia between the groups. That surprised me a little. I was expecting no difference in severe hypos but no difference in all hypos was surprising as I expected the basal to have a negative impact. Aside from that I think the results are what we have been saying for years on Proboards. So why has it had difficulties being adopted by the mainstream KOL's? I would think these KOL's should know a lot more about diabetes than some Proboards posters. We had already seen from the one testing center during the 171 study similar great results. So much so the FDA accused the good doctor of cheating by proper dosing. Why did it take this study? That's puzzled me too, but I've assumed the 171 study wasn't very persuasive for whatever reasons and at this point, I'm just grateful INHALE-3 was. |
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Post by castlerockchris on Jul 2, 2024 17:00:41 GMT -5
I appreciate what H&W has posted. It certainly makes me stop and validate or rethink my thought process on MNKD. There are a couple of points I think about constantly with MNKD: - Their (H&W's) post is correct in some regards and not in others. Historically, most of Afrezza's increase in revenue has come not due to script growth, but rather price increase, or repackaging. That being said, we have not had access to script counts for over half a year. We do not know if the Q1 increase in Afrezza revenue is the result of higher script counts or higher prices or some combination. So to make any claims here, other than revenue and margins are up, is just conjecture and impossible to support.
- People with T1 deserve a better, newer, more novel treatment methodology. Afrezza's primary benefits in my mind is the delivery system and speed with which it enters and leaves the system - not simply that it is insulin. I spent the last week with a family member who has been living with T1 for more than 30 years and uses a pump, and CGM. It should be noted that because of where she lives she does not have an Endo (nearest one is more than two hours away), but relies on a PCP to treat her T1, which I would guess is not that uncommon. She is very well educated on how to manage the disease as it applies to her. But still, it was very hard to watch. At one point she pretty much shut down for more than half a day because she had one alcoholic drink, ate a meal and shot up to 335. She then did what everyone not on Afrezza does, she dialed up some insulin through her pump. I watch as she stacked more later because she was still too high and feeling like crap. Then I watched her crash and feel like crap - not terribly, but still significantly enough that it had a significant impact. If she was on Afrezza, not guaranteed, but the data suggests, this entire episode could have been avoided. Historically, her A1C runs consistently between 7.5 - 8. I can't help but wonder what all the YO-YOing is doing to her kidneys and where it will lead, not to mention the quality of her life. She and I have spoken at length about Afrezza for years, but her PCP just does't have the where-with-all to do the education required to support prescribing it. I did share the results from Inhale-3 and she was intrigued/impressed. Not sure where it will go. I do know her pump is not working all that great and is end-of-life, but can't be replaced until 2025 because of insurance. I can't help but believe her story is not unique, and one I believe would be better if Afrezza was more main stream/accepted as a treatment option. I continue to believe that Afrezza has a place in the treatment of T1's, and while it may be small, and growing slowly, it will continue to generate worthwhile revenue and margin.
- As far as the good and bad of what we hear regarding MNKD 101 and 201 representing significant opportunities (note- not guarantees), I believe the opportunity presents itself due to the novel way they are being delivered. IMO MNKD's team knows as much or more than any other company in the world about delivering drugs to/via the lungs and the impact that has on efficacy. In the case of MNKD 101, MNKD will hopefully make an existing medication, known to cure the disease, but in no way tolerable, tolerable. I can't imagine what it must be like to be staring death in the face, having a cure, but taking that cure is worse than death. MNKD 201 will hopefully demonstrate that DPI deliver significantly increases the success rate of treatment due to how it is administered. Personally, I am only counting on one of these two making it to market. If they both make it, all that much better. But one is all it will take to push MNKD forward.
- I continue to believe that the partnership with UTHR will deliver outsized returns and growth for MNKD over the next five years in terms of revenue and profit.
- While I have had my issues with MNKD's leadership team, especially in terms of sense of urgency and transparency (note - it is not a requirement that a company be transparent other than with regard to financial reporting), I do believe they are very smart people, have learned to adapt, pivot, and apply what they learn as they move the company forward. There is no doubt the company is light years ahead of where they were five years ago, and much, much better off from a financial and tangible product pipeline stand point. Let's see if they can get Peds and one additional pipeline product across the finish line in the next 12 to 18 months. If they do, we all will be singing a much sweeter tune.
- My history with stocks has taught me that my biggest gains have come from long term holdings that people love to beat down, short, and prognosticate about eminent doom along the way. We bought APPL in 2003 when everyone said it was circling the drain - we are sitting on a 4,022% gain. We bought CELG when everyone and their brother was shorting the stock because leadership repeatedly diluted the shares - we rode it to a 3,065% gain. We bought NVDA when their lead product was video acceleration cards bought by gamers. We believed their leadership team was smart and would figure it out and boy did they. The cloud - data centers, crypto mining, AI... not quite two decades later we are sitting on a 6,537% gain (the vast majority of which came in the last five years). They all don't work out like that. But we are only a little over 14 years into owning MNKD, I continue to believe in what they are doing and that they have the potential to be my next AAPL, CELG or NVDA. Heck, we'd be thrilled if they just 10X it from here.
A very long winded way of saying, thanks H&W for giving me a reason to re-examine our investment in MNKD. I have concluded that I don't agree with your perspective and I think we will stick with it for a while longer.
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Post by sayhey24 on Jul 2, 2024 18:02:22 GMT -5
A few things Castle
Item 1. According to Mike who has said this several times most of Afrezza's increase in revenue over the last 18 months was thanks to Medicare. I don't know if thats true but I would think it is.
Item 2. For your relative, if she is really interested in afrezza have her call VDex and they can help her out via Telemed.
Item 5. I am fully expecting the kids trial results to be as good as Inhale-3. Who knows with the Mom's help maybe they could be even better. The key here is Mike needs to be working 24/7 to get insurance coverage so when the kids are approved they are not facing the cost issue.
Item 6. Assuming Mike gets the insurance coverage and once the kids are approved your long term investment should start paying off and we should be seeing $20pps in the rear view mirror.
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limo
Researcher
Posts: 82
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Post by limo on Jul 4, 2024 11:52:36 GMT -5
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Post by agedhippie on Jul 4, 2024 13:54:45 GMT -5
That is an interesting article, especially for the comments from the panel. This quote from Irl Hirsch in particular; “Somebody who is coming in with an [Hb]A1c above 7%, what we showed was that the inhaled insulin did better than the MDI in general, but not as well as the AID, but I still think the more important point of the whole thing is that depending on the patient, and their personality, and their phenotype, and their engagement, we had all of these AID people who actually did better,” Irl Hirsch, MD, professor of Medicine and Diabetes Treatment and Teaching Chair at the University of Washington, said in an interview with Pharmacy Times®."Lets unpack that. If you are on MDI and want to stay on MDI you should probably switch to Afrezza (" inhaled insulin did better than the MDI in general"), but if you are on an AID pump you probably should not switch (" but not as well as the AID"). But for me the important line was the one that followed that and is often overlooked in these discussions (" but I still think the more important point of the whole thing is that depending on the patient, and their personality, and their phenotype, and their engagement"). One size does not fit all. Endos like the KOLs understand one size does not fit all and the treatment needs to reflect that because anything involving lifestyle changes is probably a non-starter. To give a personal example; I am still on pens, and since lockdown I have got pretty slack with dosing which my A1c reflects. Consequently my endo wants to put me on an AID pump so it does the work I am slacking on and my A1c will improve. I don't like the idea but ultimately it is where I am heading because getting back into my pre-lockdown routine is never going to happen. In abstract would Afrezza work for me? Yes. In reality would I be able to sustain it? Not a bat in hells chance. To Irl Hirsch's point - personality and engagement. So what is the good news here? The good news is that more people will be given the option to try Afrezza because there is now data that says it works so endos will at least try it. Will the patients all stay on Afrezza? Some probably not for the reasons Irl Hirsch gave, and because of insurance cover, but at the end of the day a much bigger pool has just opened up with Afrezza becoming a serious option. |
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Post by prcgorman2 on Jul 4, 2024 14:47:21 GMT -5
I don’t really understand your comment about being able to “sustain” using Afrezza. But I’m sure its because I don’t understand how you assume you would use Afrezza.
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Post by agedhippie on Jul 4, 2024 16:19:42 GMT -5
I don’t really understand your comment about being able to “sustain” using Afrezza. But I’m sure its because I don’t understand how you assume you would use Afrezza. Maybe sustain is the wrong word but I think it fits. Could I take Afrezza every time I was supposed to? Over a burst of a couple of months I could probably do that, but over a lifetime I couldn't sustain that. I would start start skipping the follow up doses, snack and not dose, that sort of thing. My endo knows he could put me on a program that today that would markedly improve my A1c, but he also know that after a couple of months I would fail so he doesn't go down that path - don't set patients up for failure. |
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Post by prcgorman2 on Jul 4, 2024 16:31:27 GMT -5
When I listened to the Juicebox podcast what struck me most was the difficulty imposed by the variability of living with diabetes in administration, absorption, and action over time of especially RAA insulin which makes stacking a nightmare.
I used to think inhale a cartridge of Afrezza and it will eliminate a stubborn high, and you’re right as rain. But listening to the podcast I realized its not that simple. Afrezza is good about in and out fast, but if used in combination with an RAA and the RAA (or body reaction) kicked in, then a low could be on the way. No free lunch as it were.
Are basal insulins as variable as RAA? Or are they better at maintaining a more constant background amount of insulin for a day? If they’re more predictable, it would seem like basal + CGM + Afrezza could make life less complicated.
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Post by agedhippie on Jul 4, 2024 23:41:38 GMT -5
When I listened to the Juicebox podcast what struck me most was the difficulty imposed by the variability of living with diabetes in administration, absorption, and action over time of especially RAA insulin which makes stacking a nightmare. I used to think inhale a cartridge of Afrezza and it will eliminate a stubborn high, and you’re right as rain. But listening to the podcast I realized its not that simple. Afrezza is good about in and out fast, but if used in combination with an RAA and the RAA (or body reaction) kicked in, then a low could be on the way. No free lunch as it were. Are basal insulins as variable as RAA? Or are they better at maintaining a more constant background amount of insulin for a day? If they’re more predictable, it would seem like basal + CGM + Afrezza could make life less complicated. Basal tends to be more stable which is a problem all of it's own. You basal needs fluctuate throughout the day being high in the morning and low around 2am at night. On a pump you usually have profiles that fit that curve. The belief that diabetes is mechanistic is the bane of a Type 1 diabetics life. Your endo will happily accuse you of lying (in a nice way) if they see something that doesn't fit what they expect, but you can literally eat the same meal two days in a row with different results depending on what you ate for the previous meal, or what your level was when you ate, or even the weather. |
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Post by mango on Jul 7, 2024 7:49:14 GMT -5
I don’t really understand your comment about being able to “sustain” using Afrezza. But I’m sure its because I don’t understand how you assume you would use Afrezza. Maybe sustain is the wrong word but I think it fits. Could I take Afrezza every time I was supposed to? Over a burst of a couple of months I could probably do that, but over a lifetime I couldn't sustain that. I would start start skipping the follow up doses, snack and not dose, that sort of thing. My endo knows he could put me on a program that today that would markedly improve my A1c, but he also know that after a couple of months I would fail so he doesn't go down that path - don't set patients up for failure. Aged, what if there was a larger dose of Afrezza you could take that could potentially curtail the need for a follow up? Is a follow up the main reason why you wouldn’t start Afrezza? I wonder what percentage of VDex patients need follow ups? And what percentage take large doses into a meal and avoid needing one? I remember Bill always talking about waiting a while into the meal before taking the initial dose because it works so fast. Are people in the INHALE-3 trial taking their Afrezza too soon? |
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Post by agedhippie on Jul 7, 2024 8:22:55 GMT -5
Aged, what if there was a larger dose of Afrezza you could take that could potentially curtail the need for a follow up? Is a follow up the main reason why you wouldn’t start Afrezza? I wonder what percentage of VDex patients need follow ups? And what percentage take large doses into a meal and avoid needing one? I remember Bill always talking about waiting a while into the meal before taking the initial dose because it works so fast. Are people in the INHALE-3 trial taking their Afrezza too soon? Not having to follow up would definitely make Afrezza an option. Combined with the absorption pattern I would try that. It would need a bigger cartridge though as I usually take around 10u to 14u for a meal which would probably mean three cartridges based on the ADA comments (2.8 to 3x). I can see the large dose working to a degree, but depending on the composition of the meal you just ate. As an extreme example there is no way you could cover pizza with that approach because of the fat. On the other hand a meal with a lot of processed carbs may work. If it was me I would probably bolus at the end of the meal because I think that Afrezza is fast enough to outrun my digestion and the delay would give a better outcome. |
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Post by prcgorman2 on Jul 7, 2024 8:36:58 GMT -5
In the Juicebox podcast Mike Castagna mentioned that he was frequently asked about a 2U Afrezza cartridge (and remembering that 2U of Afrezza might be equivalent to 1U of insulin) and his first question is why would you want that? And his follow up is, are you (the person asking) using an AID pump? He said the answer was invariably yes to the AID pump. I thought that was interesting because the discussion on the board here had been a smaller than 4U cartridge would most likely benefit young T1s. Listening to the host and Mike describe how hard it is to wrestle with keeping blood glucose in range, it made me wonder if there is a market for an extra small cartridge for AID users and potentially young T1s.
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