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Post by sayhey24 on Mar 3, 2024 8:46:10 GMT -5
I sure hope Mike does not double the sales force again until we know what we are doing. We have been through this 4X now. We can't keep doing the same thing over and over. Nothing is going to change as long as the PBMs are in control. For the kids there are set number of pediatric centers that they need to target - I think the number is 40. At most we need 4 sales reps for those forty sites. Mike has to be laser focused right now and figure out the cost/insurance issue. Its time to put the big boy pants on. Few T2s will get insurance. Some T1s will but as Ginger V. found out it won't be easy. Lets assume Mike figures out the cost issue and now anyone can buy for $35 with no pre auths. Then the answer is really easy. Its the afrezza GLP study Mike mentioned with an arm of afrezza head to head against the GLPs. If he does not figure out the cost issue then the best he has is a portion of the T1 market who get through the insurance denial process. Afrezza remains a niche drug. Doing a T2 study would make ZERO sense. At that point the money is better spent on lobbying the ADA for SoC T1 changes and then hope for better T1 insurance coverage. I believe the CIPLA Trial targets the T2 market. I'm not saying the FDA will consider their trial data but I seem to remember CIPLA's trial is focused on T2. Yes its T2 and I sure hope they properly dosed. For some reason they did not use CGMs. They basically copied the 175 protocol. There may be some adding afrezza to GLPs but we will need to see. You do see the problem? T2s are not getting insurance coverage. PBMs have blocked afrezza. Even if we get SoC updates the PBMs will block coverage to keep afrezza a niche treatment. The 175 already shows adding afrezza to existing treatments works. At Week 24, treatment with AFREZZA plus OADs provided a mean reduction in HbA1c that was statistically significantly greater compared to the HbA1c reduction observed in the placebo group. Mike needs to be laser focused solving the cost issue. His last bad idea was buying V-Go for the T2 market instead of fixing the issue. |
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Post by prcgorman2 on Mar 3, 2024 11:31:01 GMT -5
How does it lower their costs??? A diabetic can spend upwards of $35,000 in costs every time they go to the Emergency Room for a Hypoglycemic Event. As you know Afrezza has a very LOW HYPO history and insurance companies will notice. I have an ER doctor friend and he says he sees about 2 patients a week with Hypoglycemic problems. Add in LESS EFFECTS of High BG....they will save money on comorbidity problems. I honestly don't know how you can spend upwards of $35,000 on ER costs for treating hypoglycemia. Hypoglycemia in the ER is treated by a glucagon shot which provokes a liver glucose dump and fixes the problem. Worst case it is an IV drip with glucose and possibly potassium. Maybe there are other treatments but nobody I know has ever had anything else - maybe they were just lucky. My suspicion is that to run up a large bill the primary issue is going to be something other than hypoglycemia although hypoglycemia could be in the mix.
Looking at the numbers though, 2 people per shift per week is a tiny number given the size of the insulin using population. It would be very easy to comfortably exceed any saving by the higher insulin cost of using Afrezza. It would probably be more cost effective to look at what caused that hypo and how to manage it next time (misjudging a dose size is the most common one I have heard of and Afrezza will not help there.)
Right now the only outcomes data is from the phase 3 trial and Afrezza has the same results as RAA so the comorbidity benefit is not something insurers are going to accept. Long term trial data would fix that.
I like the idea of a long-term trial but will argue Afrezza human insulin helps prevent hypos. If I remember correctly, less hypos was one of the most important benefits to Sam Finta. |
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Post by jkendra on Mar 3, 2024 11:40:51 GMT -5
I'm sorry, but did you just tell Aged to GFH peppy? If so, timely. No. I need agedhippie . A veritable fountain of knowledge. BTW have you ALL been to the MNKD trading and technical analysis thread? Let's see 108 members yesterday....were able to read that thread. A shame that thread is locked to account holders only. Could be some vital information to potential shareholders. |
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Post by porkini on Mar 3, 2024 11:52:30 GMT -5
No. I need agedhippie . A veritable fountain of knowledge. BTW have you ALL been to the MNKD trading and technical analysis thread? Let's see 108 members yesterday....were able to read that thread. . Could be some vital information to potential shareholders. Not really, accounts are free and easily signed up for. No shame there at all. |
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Post by jkendra on Mar 3, 2024 11:56:32 GMT -5
Trying to do some marketing here 😊
I think there was a word made up for those large sum of people ….Lurkers?
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Post by peppy on Mar 3, 2024 11:56:51 GMT -5
No. I need agedhippie . A veritable fountain of knowledge. BTW have you ALL been to the MNKD trading and technical analysis thread? Let's see 108 members yesterday....were able to read that thread. A shame that thread is locked to account holders only. Could be some vital information to potential shareholders. Being that the cup and handle break out, that has been watched now forever is going to happen, The word about cup and handles I had heard, was people are so exhausted, they give up just prior to the break. Mentally, I need to turn the events to mean..... there was my counter indicator.... the darkness.... prior to the dawn. I have kept my Phalanges under control. |
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Post by jkendra on Mar 3, 2024 12:15:51 GMT -5
A shame that thread is locked to account holders only. Could be some vital information to potential shareholders. Being that the cup and handle break out, that has been watched now forever is going to happen, The word about cup and handles I had heard, was people are so exhausted, they give up just prior to the break. Mentally, I need to turn the events to mean..... there was my counter indicator.... the darkness.... prior to the dawn. I have kept my Phalanges under control. The infamous cup and handle. Glad to have a chance to witness in real time. |
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Post by peppy on Mar 3, 2024 12:17:08 GMT -5
Blah, blah, blah..... I have a nickel in me.
Thinking it through this way.
MNKD has a few days now with 10% moves, the one on Friday held the 10%.
Presently MNKD is trading at $4.50. a 10% move is $4.95. Let's see if MNKD can go another 10% tomorrow on increasing volume.
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Post by peppy on Mar 3, 2024 13:06:23 GMT -5
More nickel, blah, blah, lah. MNKD share price moved 95 cents last week which was a 26% move.
Just looking. another 26% move is now = $1.17.
$4.50 + 1.17 = $5.67. Point of break out.
Just looking.
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Post by agedhippie on Mar 3, 2024 15:01:55 GMT -5
I like the idea of a long-term trial but will argue Afrezza human insulin helps prevent hypos. If I remember correctly, less hypos was one of the most important benefits to Sam Finta. Less hypos is always good. From day one I have said that the best way to sell this though is to talk about predictable absorption. Look at Ginger, she won her appeal for Afrezza on exactly those grounds. That is the fastest path to grow although it is still not mass market. |
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Post by Thundersnow on Mar 3, 2024 15:27:40 GMT -5
How does it lower their costs??? A diabetic can spend upwards of $35,000 in costs every time they go to the Emergency Room for a Hypoglycemic Event. As you know Afrezza has a very LOW HYPO history and insurance companies will notice. I have an ER doctor friend and he says he sees about 2 patients a week with Hypoglycemic problems. Add in LESS EFFECTS of High BG....they will save money on comorbidity problems. I honestly don't know how you can spend upwards of $35,000 on ER costs for treating hypoglycemia. Hypoglycemia in the ER is treated by a glucagon shot which provokes a liver glucose dump and fixes the problem. Worst case it is an IV drip with glucose and possibly potassium. Maybe there are other treatments but nobody I know has ever had anything else - maybe they were just lucky. My suspicion is that to run up a large bill the primary issue is going to be something other than hypoglycemia although hypoglycemia could be in the mix.
Looking at the numbers though, 2 people per shift per week is a tiny number given the size of the insulin using population. It would be very easy to comfortably exceed any saving by the higher insulin cost of using Afrezza. It would probably be more cost effective to look at what caused that hypo and how to manage it next time (misjudging a dose size is the most common one I have heard of and Afrezza will not help there.)
Right now the only outcomes data is from the phase 3 trial and Afrezza has the same results as RAA so the comorbidity benefit is not something insurers are going to accept. Long term trial data would fix that.
I remember when Mike discussed this during a presentation. Most Hypo events can land a person in the ER for up to 15 hours. You know how they operate and every minute the bill goes up. |
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Post by sayhey24 on Mar 3, 2024 15:49:35 GMT -5
IMO......if you BUILD IT....They WILL COME. Once insurance cos. see the Superior Data and realize this will LOWER THEIR COSTS...they will come ONBOARD. Then it will snowball down to the doctors and make their lives easier. IT'S ALL ABOUT THE DATA. How will it lower their costs? There is no data to quantify that and that is the problem - outcomes are what matter. Right now Afrezza is a lot more expensive to insurers than RAA, and there is nothing to say that over the long term there will be less complications. Doctors may well like it, but if the insurers are not covering it the doctors will not be writing prescriptions. I recently talked with the CEO of a very large BP. He doesn't not sell drugs into the diabetes space but gave me his impression of what is going on with afrezza. Why is afrezza a lot more expensive to insurers than the RAAs? Its what the PBMs are negotiating for the insurers. Are we saying the PBMs can't negotiate a better deal with Mike or are we saying the PBMs don't want to negotiate a better deal with Mike? I think its the latter. Are we saying Mike is intentionally pricing afrezza out of the market? I don't think so. This is what is in the SoC - "Inhaled human insulin has a rapid peak and shortened duration of action compared with RAA and may cause less hypoglycemia and weight gain" OK, the words less hypoglycemia are already in the SoC so I guess Dave Kendall's study plus the 171 were good enough but this did not move the needle. Why not? Based on Thundersnow's theory insurance companies should be jumping all over this to reduce hypos, right? Nope. Mike has a problem and he better figure out how to solve it. The PBMs are intentionally blocking afrezza insurance coverage to keep it a niche drug. By making the doctors and patients do what Ginger V. had to do to get coverage dramatically limits adoption and only in the T1 community. Few if any T2s will ever get coverage. Until Mike solves this issue, afrezza is doomed to the land of the misfit niche drugs. |
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Post by agedhippie on Mar 3, 2024 15:54:43 GMT -5
I remember when Mike discussed this during a presentation. Most Hypo events can land a person in the ER for up to 15 hours. You know how they operate and every minute the bill goes up. I can quite imagine that is possible. However, the number of times you end up in ER for a hypo is vanishingly small. Your body is really good at telling you that you are low in time for you to fix it. There is a group where that is not true though. If you are hypo-unaware you don't know you are low until you collapse. That used to be the only way you got a CGM in the old days. The thing with treating a hypo in hospital is that there is no expensive procedures involved, it's really just a glucagon shot and, maybe, an IV. If they keep you in it is for observation. It's why I think $35k is rather high. |
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Post by agedhippie on Mar 3, 2024 16:01:30 GMT -5
... Why is afrezza a lot more expensive to insurers than the RAAs? Its what the PBMs are negotiating for the insurers. Are we saying the PBMs can't negotiate a better deal with Mike or are we saying the PBMs don't want to negotiate a better deal with Mike? ... Absolutely don't want to. Why do you think your insurer covers Humalog or Novolog, but not both? It's because the pharmas offer bundles. If you are a single drug company like MNKD then you cannot compete on price because if the PBM takes your insulin the pharma will jack up the price for all the other drugs the PBM needs to get from them. The only way you can beat that is to get trial data showing superior long term outcomes. |
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Post by sayhey24 on Mar 3, 2024 16:24:44 GMT -5
... Why is afrezza a lot more expensive to insurers than the RAAs? Its what the PBMs are negotiating for the insurers. Are we saying the PBMs can't negotiate a better deal with Mike or are we saying the PBMs don't want to negotiate a better deal with Mike? ... Absolutely don't want to. Why do you think your insurer covers Humalog or Novolog, but not both? It's because the pharmas offer bundles. If you are a single drug company like MNKD then you cannot compete on price because if the PBM takes your insulin the pharma will jack up the price for all the other drugs the PBM needs to get from them. The only way you can beat that is to get trial data showing superior long term outcomes. This is a brilliant statement "you cannot compete on price because if the PBM takes your insulin the pharma will jack up the price for all the other drugs the PBM needs to get from them". As far as the trial data we already have it. Afrezza will cause less hypos but thats not going to do anything as long as the PBM is jacking the price of afrezza out of the market and blockading PWDs from getting it. As you said they need to keep doing this no matter what or they screw up their "bundles". Its sounds to me Mike is between a rock and hard place if he wants to keep dealing through the PBMs and afrezza is doomed to the land of misfit niche drugs. |
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