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Post by mango on Jun 25, 2024 14:40:50 GMT -5
My thinking is this—
Afrezza restores the first phase insulin response. Initially it may take a small or medium amount of Afrezza to restore post prandial glucose homeostasis via being the source of the exogenous first phase insulin response. As glucose levels begin to balance and a person begins introducing glucose homeostasis into the body, beta cells are becoming repaired and less stressed, etc etc. It just makes sense a larger amount of Afrezza, or, in other words, a larger initial rapid burst of insulin (first phase insulin secretion) in response to a meal (glucose stimulated insulin secretion) is needed.
The pancreas doesn’t release a precise amount of insulin during the first phase in people without diabetes. The preloading of insulin for the first phase insulin release is determined from a previous meal via beta cell memory. It’s usually more insulin than is needed but that’s not an issue. And if too little was initially released, more follows. We should definitely be dosing Afrezza higher. It’s what the pancreas already does.
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Post by Thundersnow on Jun 25, 2024 15:58:45 GMT -5
My thinking is this— Afrezza restores the first phase insulin response. Initially it may take a small or medium amount of Afrezza to restore post prandial glucose homeostasis via being the source of the exogenous first phase insulin response. As glucose levels begin to balance and a person begins introducing glucose homeostasis into the body, beta cells are becoming repaired and less stressed, etc etc. It just makes sense a larger amount of Afrezza, or, in other words, a larger initial rapid burst of insulin (first phase insulin secretion) in response to a meal (glucose stimulated insulin secretion) is needed. The pancreas doesn’t release a precise amount of insulin during the first phase in people without diabetes. The preloading of insulin for the first phase insulin release is determined from a previous meal via beta cell memory. It’s usually more insulin than is needed but that’s not an issue. And if too little was initially released, more follows. We should definitely be dosing Afrezza higher. It’s what the pancreas already does. True Mango but the major problem is MINDSET. When Diabetics on insulin hear TAKE A HIGHER DOSE.....They freak out. Diabetics for 100+ years have been conditioned if they take too much insulin they will go into a diabetic coma so they AVOID the higher dose. The doctor (which is in the same boat) needs to be educated that taking a higher dose is fine. It's not a 1:1 comparison with SubQ. EDUCATION IS PRIORITY NOW for the salesforce. The question will be.....will doctors listen? Will they take notice of the data and CHANGE THEIR WAY OF TRAINING? |
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Post by agedhippie on Jun 25, 2024 17:05:35 GMT -5
True Mango but the major problem is MINDSET. When Diabetics on insulin hear TAKE A HIGHER DOSE.....They freak out. Diabetics for 100+ years have been conditioned if they take too much insulin they will go into a diabetic coma so they AVOID the higher dose. The doctor (which is in the same boat) needs to be educated that taking a higher dose is fine. It's not a 1:1 comparison with SubQ. EDUCATION IS PRIORITY NOW for the salesforce. The question will be.....will doctors listen? Will they take notice of the data and CHANGE THEIR WAY OF TRAINING? It's on the doctors to explain that 1u of Afrezza is much weaker than 1u of RAA and so you need to take more. I don't see it being an obstacle if they understand why their endo is telling them to take more. The bigger question is if the salesforce is allowed to talk to doctors about this since they cannot go off-label in selling and the label sets the dose. This is why the label still matters. The KOLs like the panel are all endos in big hospital systems, the question is what it looks like when you get away from those hospitals? The second question is how much those other prescribers matter to sales. |
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Post by Clement on Jun 25, 2024 18:50:54 GMT -5
^ "the panel are endocrinologists in big hospital sytems"
I guess I'm more of a road warrior than a general back at command HQ. I would like to see significant Afrezza take-up from the those big hospital systems.
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Post by sayhey24 on Jun 25, 2024 20:32:23 GMT -5
True Mango but the major problem is MINDSET. When Diabetics on insulin hear TAKE A HIGHER DOSE.....They freak out. Diabetics for 100+ years have been conditioned if they take too much insulin they will go into a diabetic coma so they AVOID the higher dose. The doctor (which is in the same boat) needs to be educated that taking a higher dose is fine. It's not a 1:1 comparison with SubQ. EDUCATION IS PRIORITY NOW for the salesforce. The question will be.....will doctors listen? Will they take notice of the data and CHANGE THEIR WAY OF TRAINING? It's on the doctors to explain that 1u of Afrezza is much weaker than 1u of RAA and so you need to take more. I don't see it being an obstacle if they understand why their endo is telling them to take more. The bigger question is if the salesforce is allowed to talk to doctors about this since they cannot go off-label in selling and the label sets the dose. This is why the label still matters. The KOLs like the panel are all endos in big hospital systems, the question is what it looks like when you get away from those hospitals? The second question is how much those other prescribers matter to sales. Here is what the label says - whats the issue? It sounds like the label tells the doctor to adjust as needed "Adjust the dosage of AFREZZA based on the individual's metabolic needs, blood glucose monitoring results and glycemic control goal. Dosage adjustments may be needed with changes in physical activity, changes in meal patterns (i.e., macronutrient content or timing of food intake), changes in renal or hepatic function or during acute illness [see Warnings and Precautions (5.3), and Use in Specific Populations (8.5, 8.6)]. Carefully monitor blood glucose control in patients requiring high doses of AFREZZA." |
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Post by sayhey24 on Jun 25, 2024 20:37:33 GMT -5
^ "the panel are endocrinologists in big hospital sytems" I guess I'm more of a road warrior than a general back at command HQ. I would like to see significant Afrezza take-up from the those big hospital systems. Wouldn't we all. At $1200 a box thats not going to happen. Mike can run a 2 year sale for $35 a box or we can wait for insurance coverage which will take about 2 years. Its really all on Mike at this point. |
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Post by letitride on Jun 26, 2024 2:17:20 GMT -5
Insurance coverage may get a kick in the ass from the FDA and the FEDS. In light of the recent insulin pen shortage, this has been known to happen with other drugs in the past.
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limo
Researcher
Posts: 82
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Post by limo on Jun 26, 2024 9:32:39 GMT -5
Here's a question. Now that we have had the successful results from the 17 week point, what more are we hoping for for the rest of the trial? i suppose we might see even more improvement on the results but surely we now know roughly what to expect. MC mentions during a recent call that he wass waiting on the result before investing in the scale up of afrezza, i assume this was enough for him to decide to go ahead? havent seen any new sales roles advertised yet, perhaps we are partnering??
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Post by prcgorman2 on Jun 26, 2024 9:46:51 GMT -5
Here's a question. Now that we have had the successful results from the 17 week point, what more are we hoping for for the rest of the trial? i suppose we might see even more improvement on the results but surely we now know roughly what to expect. MC mentions during a recent call that he wass waiting on the result before investing in the scale up of afrezza, i assume this was enough for him to decide to go ahead? havent seen any new sales roles advertised yet, perhaps we are partnering?? cjm18 provided a reference to Slide 15 of May’s q2 call.
investors.mannkindcorp.com/static-files/3d2fbb7e-34d6-4338-b499-c7d7098dad0f
In that slide the stated goals of the pump/switch (INHALE-3) trial are:
– Equal efficacy to Standard of Care including an AID system
– Update Conversion Figure 1 in the Afrezza label
I agree that Mike did say they were waiting on results of the trials (and I'll add he implied the desired positive effect on marketing Afrezza) to decide next steps for investing in the Insulin Business Unit (IBU) and Afrezza specifically.
Given the substantial air play on the results of the INHALE-3 trial presented at last week's ADA symposium, I'm hopeful MannKind will register an uptick in Afrezza sales, but I don't expect we'll necessarily see a concomitant and immediate uptick in sales person hiring.
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Post by cretin11 on Jun 26, 2024 11:00:25 GMT -5
... perhaps we are partnering?? We can dream!  |
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Post by sayhey24 on Jun 26, 2024 11:25:15 GMT -5
Here's a question. Now that we have had the successful results from the 17 week point, what more are we hoping for for the rest of the trial? i suppose we might see even more improvement on the results but surely we now know roughly what to expect. MC mentions during a recent call that he wass waiting on the result before investing in the scale up of afrezza, i assume this was enough for him to decide to go ahead? havent seen any new sales roles advertised yet, perhaps we are partnering?? Pretty much everything Mike has done in the endo space up until Inhale-3 has been a disaster. He needed to see market reaction to the study results and they have exceeded expectations. At this point there is zero reason to hire sales reps. Few PWDs can get insurance coverage and no one is paying $1200 a box. He now has ammunition to address this. For the T1 market, next up are the kids. Lets hope we have the cost issued solved by this time next year so once approved they can start using it. For the T2s we have Inhale-2 results. This is the big decision area for Mike. IMO he should be doing a study adding afrezza to GLP1 users and he should be starting that asap. Focus of the sales reps for the time being should be key accounts who know how to get insurance coverage and growing that base. |
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Post by prcgorman2 on Jun 26, 2024 11:50:01 GMT -5
... perhaps we are partnering?? We can dream! MannKind already partnered with Biomm (Brazil) and Cipla (India), and Mike has indicated a willingness to entertain a general (i.e., global) international marketing partnership for sales outside of the US. Perhaps the INHALE-3 results will kick-start those kinds of discussions.
Biomm fizzled and COVID didn't help. I kind of assumed the same happened with Cipla in India but it appears to continue to have life. India is a wildcard. The potential market is huge but the US price would be unsustainable so it will be interesting to watch what happens there and what effects it may have, if any, in the US market. A substantial patient base with improved health and a noted lack of severe hypoglycemic events could prove influential. And, as has been noted by Mike Castagna and Stephen Binder, the unit cost of Afrezza will improve as more units get produced to support a larger customer base.
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Post by hellodolly on Jun 26, 2024 11:50:18 GMT -5
We've seen the results through the first 13 weeks and there are ~17 weeks left. We have also seen the key principal investigators reactions as well as heard the statement made by Dr. Aleppo that she's been so surprised by the results, now that safety is no longer an issue, she is now prescribing her own patients in her private practice to Afrezza. That said, we can all acknowledge there was a huge learning curve for these doctors.
Now that they docs have got this figured out, can they share their findings with the trial participants and explain to them that if they want better results, they'll need to dose up more before bedtime, take more 1-2 hours after a meal and disregard the definition of "unit" as a straight 1:1 comparison with RAA, etc.? Will that be a change to the current trial protocol? Could that skew the trial. Would we see better results?
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Post by radgray68 on Jun 26, 2024 12:01:56 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.
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Post by chauffe00 on Jun 26, 2024 18:11:33 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… 😎 |
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