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Post by peppy on Mar 5, 2024 19:16:26 GMT -5
yes, so back to my question.... Is it a G6 or G7 under a different name for over the counter sale? Its neither. Its a new product. It does not provide features like alerting for hypos. Its is not FDA approved for T1s. not not approved for insulin taking type two's Is the only difference the alerts? |
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Post by sayhey24 on Mar 5, 2024 19:18:43 GMT -5
Irl Hirsch has a paper coming out in Diabetes Technology and Therapeutics titled: Should we Bury the HbA1c? Fascinating title for a paper. Irl must be reading Proboards. When did we start saying that? 8 years ago? |
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Post by sayhey24 on Mar 5, 2024 19:23:56 GMT -5
Its neither. Its a new product. It does not provide features like alerting for hypos. Its is not FDA approved for T1s. not not approved for insulin taking type two's Is the only difference the alerts? When I get one and try it out I will let you know. I sent an email to see if I may be able to get one in a couple of weeks. The sensing technology is going to be the same. The software will limit what features will be enabled. The theory is T2s not on "insulin" won't get hypos. Our theory is T2s using only afrezza have to try really hard to get a hypo. Those on subq insulin get hypos. For them Medicare pays for the G7. For those on a Medicare Advantage plan which pays for OTC medical items the Stelo should be covered. |
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Post by peppy on Mar 5, 2024 19:28:45 GMT -5
not not approved for insulin taking type two's Is the only difference the alerts? When I get one and try it out I will let you know. I sent an email to see if I may be able to get one in a couple of weeks. The sensing technology is going to be the same. The software will limit what features will be enabled. The theory is T2s not on "insulin" won't get hypos. Our theory is T2s using only afrezza have to try really hard to get a hypo. Those on subq insulin get hypos. For them Medicare pays for the G7. It would get very interesting if MNKD could get Afrezza REGULAR insulin over the counter with the device. Yes, I want to get one as well. The bouchure, "The Stelo Glucose Biosensor System may also help the user better understand how lifestyle and behavior modification, including diet and exercise, impact glucose excursion. The user is not intended to take medical action based on the device output without consultation with a qualified healthcare professional." I want to see...... www.dexcom.com/en-us/stelo15 days worth of site. . |
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Post by peppy on Mar 5, 2024 19:35:42 GMT -5
Back to year end results, perhaps we should type about the fact that MNKD is breaking out and is going to leave the trading range share price has been in for 6 years. On heavy volume,
Since there are 83 guests in site.
$4.75
37.28%
+1.29 1M
2023 Total revenues of $199M; +99% vs. 2022
4Q 2023 Total revenues of $58M; +62% vs. 2022
4Q 2023 Net income of $1M; Non-GAAP net income of $7M
$302M of cash and cash equivalents and investments at December 31, 2023
investors.mannkindcorp.com/news-releases/news-release-details/mannkind-corporation-reports-2023-fourth-quarter-and-full-year
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Post by sayhey24 on Mar 5, 2024 19:37:15 GMT -5
When I get one and try it out I will let you know. I sent an email to see if I may be able to get one in a couple of weeks. The sensing technology is going to be the same. The software will limit what features will be enabled. The theory is T2s not on "insulin" won't get hypos. Our theory is T2s using only afrezza have to try really hard to get a hypo. Those on subq insulin get hypos. For them Medicare pays for the G7. It would get very interesting if MNKD could get Afrezza REGULAR insulin over the counter with the device. Yes, I want to get one as well. The bouchure, "The Stelo Glucose Biosensor System may also help the user better understand how lifestyle and behavior modification, including diet and exercise, impact glucose excursion. The user is not intended to take medical action based on the device output without consultation with a qualified healthcare professional." I want to see...... www.dexcom.com/en-us/stelo15 days worth of site. . Peppy - this is what we talked about years ago - the day glucose monitoring becomes ubiquitous. Of course we will still needs Apple's non-invasive watch but this is a big step in the right direction. The problem is T2s can't get afrezza. If Mike does a deal with Mark Cuban things could be much different but then Mike declares war on the PBMs. Thats a big decision but right now afrezza is being held captive. |
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Post by sayhey24 on Mar 5, 2024 19:39:51 GMT -5
Back to year end results, perhaps we should type about the fact that MNKD is breaking out and is going to leave the trading range share price has been in for 6 years. On heavy volume, Since there are 83 guests in site. $4.75 37.28% +1.29 1M 2023 Total revenues of $199M; +99% vs. 2022 4Q 2023 Total revenues of $58M; +62% vs. 2022 4Q 2023 Net income of $1M; Non-GAAP net income of $7M $302M of cash and cash equivalents and investments at December 31, 2023 investors.mannkindcorp.com/news-releases/news-release-details/mannkind-corporation-reports-2023-fourth-quarter-and-full-year We might get from the $3.50 to $5.50 range to the $5.50 to $7.50 trading range but as long as afrezza is held captive our primary revenue is coming from Tyvaso DPI and that is very predictable. |
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Post by peppy on Mar 5, 2024 19:44:47 GMT -5
Back to year end results, perhaps we should type about the fact that MNKD is breaking out and is going to leave the trading range share price has been in for 6 years. On heavy volume, Since there are 83 guests in site. $4.75 37.28% +1.29 1M 2023 Total revenues of $199M; +99% vs. 2022 4Q 2023 Total revenues of $58M; +62% vs. 2022 4Q 2023 Net income of $1M; Non-GAAP net income of $7M $302M of cash and cash equivalents and investments at December 31, 2023 investors.mannkindcorp.com/news-releases/news-release-details/mannkind-corporation-reports-2023-fourth-quarter-and-full-year but as long as afrezza is held captive our primary revenue is coming from Tyvaso DPI and that us very predictable. it is happening in front of your eyeballs, and it is happening fast. Don't blink. I am catching you up on that program Sayhey, I hope I do not get in trouble.... schrts.co/FqGNqAuj |
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Post by jkendra on Mar 5, 2024 21:13:53 GMT -5
We capping this stock at $7.50 ?  |
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Post by prcgorman2 on Mar 5, 2024 21:47:26 GMT -5
It would get very interesting if MNKD could get Afrezza REGULAR insulin over the counter with the device. Yes, I want to get one as well. The bouchure, "The Stelo Glucose Biosensor System may also help the user better understand how lifestyle and behavior modification, including diet and exercise, impact glucose excursion. The user is not intended to take medical action based on the device output without consultation with a qualified healthcare professional." I want to see...... www.dexcom.com/en-us/stelo15 days worth of site. . Peppy - this is what we talked about years ago - the day glucose monitoring becomes ubiquitous. Of course we will still needs Apple's non-invasive watch but this is a big step in the right direction. The problem is T2s can't get afrezza. If Mike does a deal with Mark Cuban things could be much different but then Mike declares war on the PBMs. Thats a big decision but right now afrezza is being held captive. Check this out. Two things. First, I’m in the camp with Bill McCullough. DATA DATA DATA. If MNKD is being held captive it isn’t because Mike doesn’t try to swing for the fences (he does but not in a flamboyant “Damn the torpedoes!” way), it is because prescribers are not persuaded and as Bill has emphasized it is DATA DATA DATA that will change that. So there, I think your Afrezza + CGM + GLP (in some combination of trials perhaps) is a persuasive argument. But, I don’t call that Afrezza is “held captive”. I call that SNAFU. There ain’t no magic. Full-scale, multi-arm, clinical trials. Early (failed, through no fault of MC), and often (in honor of Super Tuesday). But as Mike and Steven both mentioned in the recent 4Q and EOY 23 earnings call, decision making on Afrezza (the dominant product in the Insulin Business Unit) is based on DATA DATA DATA. It’s success-based. If the results are good, and marketing on the results is good, than feed the monster. Second thing. Peppy’s excellent recital of MNKD financial results in the last quarter and year end 2023 not only identified the more than $300M in cash in the bank (drawing more interest than the interest paid on the $230M convertible bond), additionally we’re in sight of all debt retired by end of 2026. $33M, the remaining debt on the MidCap loan, will be paid off 1H 2024. For those not paying attention, the 3Q 2023 earnings report estimated the MidCap loan would be paid off in 2024, but 1H 2024 is more precise, and good news. Considering that’s expected to be paid with cash from operations, it implies there will be $33M free (at least) in 2H 2024 that can be used for a combination of things such as improving the EPS story and/or funding pipeline or trial work. Further, the $9M of Mann Group ATM is expected to be paid off according to schedule by EOY 2025. Given the outlook on the MidCap loan, payoff of the measly $9M seems extremely likely. Last but not least, the combination of earnings from operations, the Saagard agreement of $150M plus a possible (likely?) additional $50M if Tyvaso DPI milestones are met, plus existing cash in the bank, implies the $230M convertible notes may be able to be retired entirely using cash eliminating any further dilution (for paying off debt anyway). That is a remarkable debt financing story for any company, let alone one that had been swirling around the drain in 2017. No wonder the volume of trades is being driven by investor confidence. MNKD is still a speculative stock, but its looking more and more blue-chip. |
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Post by sayhey24 on Mar 6, 2024 6:10:18 GMT -5
Peppy - this is what we talked about years ago - the day glucose monitoring becomes ubiquitous. Of course we will still needs Apple's non-invasive watch but this is a big step in the right direction. The problem is T2s can't get afrezza. If Mike does a deal with Mark Cuban things could be much different but then Mike declares war on the PBMs. Thats a big decision but right now afrezza is being held captive. Check this out. Two things. First, I’m in the camp with Bill McCullough. DATA DATA DATA. If MNKD is being held captive it isn’t because Mike doesn’t try to swing for the fences (he does but not in a flamboyant “Damn the torpedoes!” way), it is because prescribers are not persuaded and as Bill has emphasized it is DATA DATA DATA that will change that. So there, I think your Afrezza + CGM + GLP (in some combination of trials perhaps) is a persuasive argument. But, I don’t call that Afrezza is “held captive”. I call that SNAFU. There ain’t no magic. Full-scale, multi-arm, clinical trials. Early (failed, through no fault of MC), and often (in honor of Super Tuesday). But as Mike and Steven both mentioned in the recent 4Q and EOY 23 earnings call, decision making on Afrezza (the dominant product in the Insulin Business Unit) is based on DATA DATA DATA. It’s success-based. If the results are good, and marketing on the results is good, than feed the monster. Second thing. Peppy’s excellent recital of MNKD financial results in the last quarter and year end 2023 not only identified the more than $300M in cash in the bank (drawing more interest than the interest paid on the $230M convertible bond), additionally we’re in sight of all debt retired by end of 2026. $33M, the remaining debt on the MidCap loan, will be paid off 1H 2024. For those not paying attention, the 3Q 2023 earnings report estimated the MidCap loan would be paid off in 2024, but 1H 2024 is more precise, and good news. Considering that’s expected to be paid with cash from operations, it implies there will be $33M free (at least) in 2H 2024 that can be used for a combination of things such as improving the EPS story and/or funding pipeline or trial work. Further, the $9M of Mann Group ATM is expected to be paid off according to schedule by EOY 2025. Given the outlook on the MidCap loan, payoff of the measly $9M seems extremely likely. Last but not least, the combination of earnings from operations, the Saagard agreement of $150M plus a possible (likely?) additional $50M if Tyvaso DPI milestones are met, plus existing cash in the bank, implies the $230M convertible notes may be able to be retired entirely using cash eliminating any further dilution (for paying off debt anyway). That is a remarkable debt financing story for any company, let alone one that had been swirling around the drain in 2017. No wonder the volume of trades is being driven by investor confidence. MNKD is still a speculative stock, but its looking more and more blue-chip. You can keep believing its DATA DATA DATA but its more than that. Here is a simple example - Ginger Vieira. When it comes to afrezza power users I would put her right at the top. She has been using and writing about afrezza for years. She changes insurance, has to go through the pre auth process, gets denied and her case is closed. On appeal she claims another medical condition, lipohypertrophy and then gets approved. If it were not for this other medical condition she was being denied, case closed. According to the FDA approved afrezza label during the 175 study afrezza provided a mean reduction in HbA1c that was statistically significantly greater compared to the HbA1c reduction observed with those that did not add afrezza to their current treatment. OK - afrezza wins. You would think if you were a T2 taking metformin and you were not controlled and your doctor prescribed to add afrezza your insurance would cover it. Nope - it will not. The PBM will deny coverage. You are not getting afrezza. This is not a prescriber issue. We have had four waves of sales rep "teams" and they have all failed. Why? Don't you think each new sales rep could at least get a few new doctors to prescribe? They have and they have prescribed and insurance gets denied and denied and denied. Then Mike blames the reps and fires them all. We are on another Wave right now but this time they are focusing on the "key accounts" which makes sense with this blockade. We use to track new scripts and then the re-ups and nearly all new prescriptions would NOT get refilled. Why? We heard all kinds of reasons including the cough but the simple reason is insurance denied coverage. As far as Mike swinging for the fences with the T2 market Mike took his ball and went home. He 100% gave up on the T2 market with afrezza. He told us that. He bought V-Go. spent $20M and told us that was for the T2 market and afrezza was for the T1 market. Why? He knows the PBMs are blocking coverage and for a T2 its near impossible to get insurance coverage. Of course now that we see V-Go is a boat anchor he has to pivot and mentions afrezza as an adder to GLPs but he knows no matter how great the results are the T2s are not getting insurance. Doing such as study would produce great results and ZERO sales and therefore be a waste of money. Aged has explained the situation. BP is controlling the PBMs by "bundling" their products. If the PBM offers afrezza, the BPs will jack up their prices on other "bundled" drugs. PBMs will not cover afrezza. When the kids get approved why should we think PBMs are going to cover afrezza? They still need their bundles. Unless these kids can show another medical condition they are not getting coverage. They will all need to go through the pre auth process and most will be denied. Maybe they will all have needle phobia but they will need to show another medical condition and their doctor will need to fight for them. With the kids it may be a little easier since there are 40 major pediatric treatment centers BUT BP is going to be pressing the "Corporations" not to prescribe afrezza no matter how great the data is. If getting these kids through the pre auth process takes a lot of time and effort that means cost to the corporation and it is going to come top down - stop prescribing afrezza. I really hope I am wrong. I still remember Al Mann telling me this was going to be the greatest drug of all time and how it was going to totally change treatment of T2 diabetes. I still believe Al is right but the problem is the T2s need to be able to get it and today they can not because PBMs are blocking it. DXCM just got the Stelo approved. This is a huge new opportunity for afrezza. People are going to see their post meal spikes and want to do something about them in addition to diet. The only answer is afrezza unless everyone wants to go on the Richard Bernstein diet. Taking a puff of afrezza is a whole lot easier. The label says during the 175 trial 2% of the placebo group got hypos and 5% of the adder group got them. I bet less than 5% would get them if afrezza was a mono therapy. I bet it would be about 2%. Wouldn't it make sense to run a trial with the Stelo in one group, the G7 in another and have a placebo group and afrezza as a mono therapy and see if you can get the Stelo approved for afrezza? That would be a game changer if the T2s could get afrezza to control the post prandial spikes they are seeing on the Stelo. Today they can't and as long as afrezza is being handled by the PBMs it will remain blocked. But just DREAM that these brand new prediabetics and new T2s could get afrezza and get it cheap. That would totally change how T2 diabetes is treated and Al Mann's vision would be realized. |
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Post by dh4mizzou on Mar 6, 2024 6:54:30 GMT -5
Maybe it's time for the PBMs to go the way of the dinosaur?
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Post by agedhippie on Mar 6, 2024 7:25:58 GMT -5
Maybe it's time for the PBMs to go the way of the dinosaur? Something I pray for every day. |
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Post by sayhey24 on Mar 6, 2024 7:36:15 GMT -5
Maybe it's time for the PBMs to go the way of the dinosaur? Something I pray for every day. This is why Mark Cuban invested in CostPlusDrugs. |
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Post by agedhippie on Mar 6, 2024 7:54:27 GMT -5
... According to the FDA approved afrezza label during the 175 study afrezza provided a mean reduction in HbA1c that was statistically significantly greater compared to the HbA1c reduction observed with those that did not add afrezza to their current treatment. OK - afrezza wins. You would think if you were a T2 taking metformin and you were not controlled and your doctor prescribed to add afrezza your insurance would cover it. Nope - it will not. The PBM will deny coverage. You are not getting afrezza. ... Aged has explained the situation. BP is controlling the PBMs by "bundling" their products. If the PBM offers afrezza, the BPs will jack up their prices on other "bundled" drugs. PBMs will not cover afrezza. ... Wouldn't it make sense to run a trial with the Stelo in one group, the G7 in another and have a placebo group and afrezza as a mono therapy and see if you can get the Stelo approved for afrezza? ... Taking these in order... The 175 trial showed nothing unexpected. You took a group of people where oral meds were no-longer sufficient, split them in two and added Afrezza to one group. All that trial showed is that Afrezza is better than nothing (in fairness that was what had to be achieved for approval) and literally any insulin would have achieved that bar. However, the SoC says there are other things you should use before insulin, Afrezza or other RAA, and there was no trial against those and hence no coverage. PBMs can be forced to cover Afrezza provided you can clearly show a superior outcome. The poster child for this is the CGM. Insurers really didn't want to cover CGMs and I remember a time when you had to be hypo-unaware to get a CGM which is a very small group. But the CGM manufacturers put in the work with trials to prove that first all T1 had better outcomes if they used a CGM, and then the same for insulin using T2. It took over a decade but they got there in the end because they had indisputable data from multiple trials which changed the SoC forcing coverage. I would expect Afrezza with kids to follow the same pattern as with adults unless the trial can pull a rabbit out of the hat. AID pumps get really good results with kids, and are something the endos are familiar with. Pumps also absorb a lot of the workload from the kids and parents. All of that said, if the trial can turn iin significantly better results than the comparator arm I can see endos moving towards Afrezza. The benefit of large centers is that they have people whose sole job is handling pre-auths. You will not get Stelio approved for Afrezza because Stelio is explicitly not approved as a medical device. If you were taking Afrezza you can get a G6 or G7 today without any arguments, you don't need a Stelio. |
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