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Post by agedhippie on Sept 22, 2022 16:21:57 GMT -5
I remember proposing an idea for "The Afrezza Challenge" to Rose Alinaya where two groups of physicians and diabetics would compete for best results using appropriate protocols. One group was the Afrezza group. Didn't care who the non-Afrezza group would be, they would get smoked regardless. A nice prize would be handed out to the winners. Something like longer life and less neuropathy and deaths from hypos. (Just kidding about that last part.) I get the FDA would never approve of that as a valid trial, but is the FDA's approval required? It's basically the "Seeing is believing" promotion the way sayhey wanted to do it. The FDA will have a cow (worth seeing in it's own right). This idea will likely fall foul of the FDA Bad Ad program unless all claims can be supported by clinical trial data and there are no warning omissions. Mannkind has already been hit by one warning letter from the FDA back in 2018 for suggesting that there are no safety concerns associated with the use of the drug in a Facebook post. Mannkind addressed the issue, agreed not to do it again, and accepted the FDA warning. I have two thoughts about that; there is someone out there who sent in the original complaint and they are probably still out there, and the FDA are going to be a lot rougher on a second offence. |
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Post by prcgorman2 on Sept 22, 2022 16:53:54 GMT -5
I remember proposing an idea for "The Afrezza Challenge" to Rose Alinaya where two groups of physicians and diabetics would compete for best results using appropriate protocols. One group was the Afrezza group. Didn't care who the non-Afrezza group would be, they would get smoked regardless. A nice prize would be handed out to the winners. Something like longer life and less neuropathy and deaths from hypos. (Just kidding about that last part.) I get the FDA would never approve of that as a valid trial, but is the FDA's approval required? It's basically the "Seeing is believing" promotion the way sayhey wanted to do it. The FDA will have a cow (worth seeing in it's own right). This idea will likely fall foul of the FDA Bad Ad program unless all claims can be supported by clinical trial data and there are no warning omissions. Mannkind has already been hit by one warning letter from the FDA back in 2018 for suggesting that there are no safety concerns associated with the use of the drug in a Facebook post. Mannkind addressed the issue, agreed not to do it again, and accepted the FDA warning. I have two thoughts about that; there is someone out there who sent in the original complaint and they are probably still out there, and the FDA are going to be a lot rougher on a second offence. Makes me think the FDA needs to be put in charge of political advertisements because the way mud slinging is used makes me sick.
So, reading what you wrote, it sounds like a trial comparing two treatment regimens is permissible, but not done like a stunt campaign comparing Coke and Pepsi.
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Post by sayhey24 on Sept 23, 2022 7:52:23 GMT -5
If its only for insulin users, you could have fooled me - here is the commercial they are running www.ispot.tv/ad/q93a/dexcom-g6-too-many-times-sampleI never hear the word insulin. Will a CGM provide the results these people are claiming if they are not on insulin? I don't know. Dexcom sure says they are but the SoC says "routine glucose monitoring may be of limited additional clinical benefit". What is clear is that if the SoC said all new T2s should be put on a CGM that would be huge for Kevin Sayer. Now you ask why would Sayer fund an afrezza arm? Why should he. Why can't Mike offer to fund it. I bet afrezza would kick butt when paired with the G6. We know what Kevin said about afrezza when interviewed years ago - "I have never seen anything like it". My guess is he has still never seen anything like it. He also should at some point throw MNKD a bone. Kevin was there when afrezza was first developed by Al Mann and Sol. Al invented the CGM which Kevin is now selling. If Martine can throw MNKD a bone and a hand-up, I think Kevin can throw them 2 or 3 and give them a big huge. Have a look at the link that they are pushing you to in the advert ( www.dexcom/BetterWay around 20 seconds in). This is not to say that you couldn't get a doctor to prescribe you a Dexcom, but if you did and were not on MDI you are not going struggle to get insurance cover and Dexcom know that hence the focus of the page they point you at. Kevin Sayer would love all Type 2 to be on a Dexcom and he is working towards that. It used to be that insulin using Type 2 could not get a CGM, now they can. They are working on getting the SoC widened but it's an incremental (Type 1 hypo unaware -> all Type 1 -> all Type 2 MDI -> Type 2 basal only -> ...), but it takes large scale trial data at each step of the way and that takes time. The benefit from Kevin's point of view to this approach is that the insurers have to follow - no trial data == no insurance coverage. There is no way Kevin Sayer can place the interests of Mannkind over his own shareholders, that's a lawsuit waiting to happen. Likewise Martine didn't throw Mannkind a bone (or I missed it). Rather she struck a commercial deal with Mannkind and side stepped the need to have to develop or buy a DPI maker. Al Mann sold the technology, along with his company, to Medtronics for a very good price. Dexcom was set up in competition to Medtronics and I seriously doubt they feel any debt to Mannkind. You clearly must have missed Martine throwing MNKD a bone. In one of Mike's recent podcasts he talked about Martine asking how she could help during MNKD's dark days which is what led to the Tyvaso DPI partnership. My main point is the SoC says T2s monitoring their BG is a waste of time. At the same time DXCM is running ads saying using a CGM shows significant results. It can't be both. If the SoC said all new T2s as step 1 should be put on a CGM and monitored for some period of time - getting insurance to cover it would not be a problem. Insurance companies do not what a class action lawsuit for denying coverage for the standard of care. The thing is, today it is not the standard of care. For example - once they got Medicare to cover CGMS for T2s on insulin (including afrezza) insurance companies started to cover. This is not hard - its all about the SoC just as Dave Kendall told us. I am sure DXCM would love all new T2s to be put on a CGM. At the same time that is the last thing BP wants. Chris C talked about TIR. Good grief what do you think is going to happen when new T2s are put on a CGM and prescribed metformin? How about Farxiga? What would happen if they were prescribed afrezza? That my friend is the last thing BP wants. They want to hide the post prandial numbers as long as they can and keep the T2s in the dark. Having all T2s on a CGM and treating to their AGP would crush the $40B market. Al Mann made Kevin Sayer a lot of money. He can afforded to throw MNKD a bone or two. A nice big study targeting the SoC to get CGMs as step 1 for all new T2s would be a huge help. Adding an arm to include include metformin, another for SGLT2s, one for GLP1s and one for afrezza would be interesting. Doing a trial to change the SoC words should be something DXCM should be doing for their own interests. |
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Post by hellodolly on Sept 23, 2022 9:09:57 GMT -5
Have a look at the link that they are pushing you to in the advert ( www.dexcom/BetterWay around 20 seconds in). This is not to say that you couldn't get a doctor to prescribe you a Dexcom, but if you did and were not on MDI you are not going struggle to get insurance cover and Dexcom know that hence the focus of the page they point you at. Kevin Sayer would love all Type 2 to be on a Dexcom and he is working towards that. It used to be that insulin using Type 2 could not get a CGM, now they can. They are working on getting the SoC widened but it's an incremental (Type 1 hypo unaware -> all Type 1 -> all Type 2 MDI -> Type 2 basal only -> ...), but it takes large scale trial data at each step of the way and that takes time. The benefit from Kevin's point of view to this approach is that the insurers have to follow - no trial data == no insurance coverage. There is no way Kevin Sayer can place the interests of Mannkind over his own shareholders, that's a lawsuit waiting to happen. Likewise Martine didn't throw Mannkind a bone (or I missed it). Rather she struck a commercial deal with Mannkind and side stepped the need to have to develop or buy a DPI maker. Al Mann sold the technology, along with his company, to Medtronics for a very good price. Dexcom was set up in competition to Medtronics and I seriously doubt they feel any debt to Mannkind. You clearly must have missed Martine throwing MNKD a bone. In one of Mike's recent podcasts he talked about Martine asking how she could help during MNKD's dark days which is what led to the Tyvaso DPI partnership. My main point is the SoC says T2s monitoring their BG is a waste of time. At the same time DXCM is running ads saying using a CGM shows significant results. It can't be both. If the SoC said all new T2s as step 1 should be put on a CGM and monitored for some period of time - getting insurance to cover it would not be a problem. Insurance companies do not what a class action lawsuit for denying coverage for the standard of care. The thing is, today it is not the standard of care. For example - once they got Medicare to cover CGMS for T2s on insulin (including afrezza) insurance companies started to cover. This is not hard - its all about the SoC just as Dave Kendall told us. I am sure DXCM would love all new T2s to be put on a CGM. At the same time that is the last thing BP wants. Chris C talked about TIR. Good grief what do you think is going to happen when new T2s are put on a CGM and prescribed metformin? How about Farxiga? What would happen if they were prescribed afrezza? That my friend is the last thing BP wants. They want to hide the post prandial numbers as long as they can and keep the T2s in the dark. Having all T2s on a CGM and treating to their AGP would crush the $40B market. Al Mann made Kevin Sayer a lot of money. He can afforded to throw MNKD a bone or two. A nice big study targeting the SoC to get CGMs as step 1 for all new T2s would be a huge help. Adding an arm to include include metformin, another for SGLT2s, one for GLP1s and one for afrezza would be interesting. Doing a trial to change the SoC words should be something DXCM should be doing for their own interests. MNKD and DXCM should put their heads together and go for the Royal Flush. If Mike can see the Type 2 market as having even an "inth" of revenue potential, which he must, he should look at that market in the same way he feels about why the Peds trial means future potential by targeting the kids - At the end of the day, he should be thinking about using the same philosophy with Type 2s, as DXCM already is. |
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Post by agedhippie on Sept 23, 2022 10:01:50 GMT -5
You clearly must have missed Martine throwing MNKD a bone. In one of Mike's recent podcasts he talked about Martine asking how she could help during MNKD's dark days which is what led to the Tyvaso DPI partnership. My main point is the SoC says T2s monitoring their BG is a waste of time. At the same time DXCM is running ads saying using a CGM shows significant results. It can't be both. If the SoC said all new T2s as step 1 should be put on a CGM and monitored for some period of time - getting insurance to cover it would not be a problem. Insurance companies do not what a class action lawsuit for denying coverage for the standard of care. The thing is, today it is not the standard of care. ... Al Mann made Kevin Sayer a lot of money. He can afforded to throw MNKD a bone or two. A nice big study targeting the SoC to get CGMs as step 1 for all new T2s would be a huge help. Adding an arm to include include metformin, another for SGLT2s, one for GLP1s and one for afrezza would be interesting. Doing a trial to change the SoC words should be something DXCM should be doing for their own interests. Doing these in order... Martine may have asked how she could help Mannkind, but that's a business partnership - UTHR got access to a DPI solution they needed for their drugs. (And yes, I missed it) What she didn't do was spend shareholders money running an arm of a clinical trial purely for Mannkind's benefit. The SoC says that closely monitoring levels is a waste of time for T2s who are not on insulin. The DXCM advert supports this by targeting insulin using T2s as evidenced by the link the advert sends you to. DXCM are not addressing non-insulin using T2s in your example. That's not to say that DXCM wouldn't love all T2s to be on a CGM and are not working on just that. If Kevin feels he owes Al Mann anything (which I seriously doubt) then a far more appropriate target would be the AMF charity rather than a commercial public company with fairly tenuous links at this point. I am convinced that DXCM will do a clinical trial for non-insulin users to change the SoC, but if so they will be agnostic about the treatment used by the participants as they want to prove that the CGM improves the outcomes regardless of treatment. They don't care which treatment gives the best outcome, they are selling CGMs not drugs. |
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Post by prcgorman2 on Sept 23, 2022 10:23:24 GMT -5
It's interesting how weird our world is. There are marches with signs which say "my body my decision" which many big name politicians support, but yet CGMs require a prescription and marijuana is still illegal from a federal perspective.
The point here is CGMs need to be available to anyone who wants one and chooses to purchase one. It would also be good if insurance helped pay for them too when prescribed by a doctor, just as many devices are available for anyone who wants to pay but also sometimes supported as prescribed durable medical equipment. e.g., scooters, wheelchairs, etc.
Since CGMs are a combination of a disposable probe, and a reader, the CGM manufacturers should be looking for opportunities to give the CGMs away, just like HP and other printer manufacturers subsidized the price of printers with ink revenues.
DXCM has much deeper pockets than they once had. They could have what, 2x, 3x, or more of what they have now if they can change the SoC and the regulation requiring prescriptions? You'd think they would be more vocal about it. Somebody (everybody?) write Kevin Sayer. Start a reddit campaign. :-)
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Post by hopingandwilling on Sept 23, 2022 10:27:15 GMT -5
PRCGORAM,
The FDA approves comparator trials every day where one company's product is directly compared to another company's product where then there is data showing which drug has the most efficacy. In the case of MannKind, there are massive number of trials where Afrezza is compared to other insulin drugs. Another example --when a company offers a generic version of a drug, the new filing company must show efficacy when compared to the comparator drug. If you watch drug TV ads--watch one's where one company makes a direct comparison to their competitor's drug--stating what makes their product better than theirs. Look at the blood thinner drugs like Eliquis---and see what they say about the competitors. They can legal say this because they had run trials to prove the advantage. What allows Eliquis to say what they are claiming--the FDA allows it because of the direct trial data.
Just one example of Afrezza being compared is this trial--
TI is Technosphere and IA is the insulin aspart drug.
"Results
In the overall cohort (N = 309; males, 23.3%), mean (SD) age was 58.5 (8.4) years, body mass index was 30.8 (4.7) kg/m2, weight was 82.2 (13.6) kg, and duration of diabetes was 12.2 (7.1) years. An intention-to-treat cohort had 150 subjects randomized to TI (mean [SD] HbA1C: 8.9% [1.1%]) and 154 randomized to IA (mean [SD] HbA1C: 9.0% [1.3%]). At 24 weeks, mean (SD) HbA1C value declined to 7.9% (1.3%) and 7.7% (1.1%) in the TI and IA cohorts, respectively. A treatment difference of 0.26% was not statistically significant, but the predefined equivalency margin was not met. Subjects receiving TI lost 0.78 kg compared to baseline; subjects receiving IA gained 0.23 kg (P =.0007). The incidence of mild/moderate hypoglycemia was lower for the TI cohort, though not statistically significant.
Conclusion
Both TI and IA resulted in significant and clinically meaningful HbA1C reductions. TI also resulted in significant and clinically meaningful weight reductions. "
Investors should hope that at this stage of marketing Afrezza, MNKD will not waste money to find out what they already know about comparing Afrezza to competitors' drug---keep in mind, diabetic are required to use other drugs to supplement their use of Afrezza. The same requirement is not required for Afrezza's competitor insulin products. The FDA required this because they had data showing the need for the supplement--this was done based on clinical trial data.
Now back to my lurking on the sidelines watching! Watching MNKDs stock is depressing!
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Post by prcgorman2 on Sept 23, 2022 10:41:32 GMT -5
Thanks hoppingandwilling, now go write those posts on reddit and to Kevin Sayer!!
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Post by agedhippie on Sept 23, 2022 11:00:45 GMT -5
It's interesting how weird our world is. There are marches with signs which say "my body my decision" which many big name politicians support, but yet CGMs require a prescription and marijuana is still illegal from a federal perspective. The point here is CGMs need to be available to anyone who wants one and chooses to purchase one. It would also be good if insurance helped pay for them too when prescribed by a doctor, just as many devices are available for anyone who wants to pay but also sometimes supported as prescribed durable medical equipment. e.g., scooters, wheelchairs, etc. Since CGMs are a combination of a disposable probe, and a reader, the CGM manufacturers should be looking for opportunities to give the CGMs away, just like HP and other printer manufacturers subsidized the price of printers with ink revenues. DXCM has much deeper pockets than they once had. They could have what, 2x, 3x, or more of what they have now if they can change the SoC and the regulation requiring prescriptions? You'd think they would be more vocal about it. Somebody (everybody?) write Kevin Sayer. Start a reddit campaign. :-) You are in danger of getting my "Someone take the FDA out the back and shoot them (please)" rant. The FDA have nightmares about diabetics making decisions. It the reasons you get repeated recalls for the old Medtronics pumps used for in the DIY APS. Yes, that's why those pumps are expensive on the secondhand market because by hacking it you can use in in a DIY APS (#WeAreNotWaiting). The bolus calculator in meters that calculates insulin needed everywhere in the world except the US, that sort of thing. As to why a CGM is a prescription device, that makes absolutely no sense to me. The problem with the razor blade model for CGMs is that these days they mostly use smartphones rather than readers (I am not sure where the reader for my CGM is even). Dexcom used to split the transceiver and sensor so the sensor was replace more often, but with the G7 they are going to an all-in-one model like the Libre. Dexcom absolutely are going after the whole T2 market, but they are doing it in steps rather than attempting a big bang approach. They did the MOBILE trial which means T2 MDI users can get a CGM now (previously, for some reason, insulin using T2 could not get a pump or CGM, but T1 could). They have just got that extended to basal only users. They are working on the rest. Kevin knows what he is doing, and DXCOM and Abbott are both actively working on this. |
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Post by nylefty on Sept 23, 2022 11:18:23 GMT -5
Investors should hope that at this stage of marketing Afrezza, MNKD will not waste money to find out what they already know about comparing Afrezza to competitors' drug---keep in mind, diabetic are required to use other drugs to supplement their use of Afrezza. The same requirement is not required for Afrezza's competitor insulin products. The FDA required this because they had data showing the need for the supplement--this was done based on clinical trial data What other drugs are Afrezza users "required" to take? |
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Post by peppy on Sept 23, 2022 11:59:45 GMT -5
Investors should hope that at this stage of marketing Afrezza, MNKD will not waste money to find out what they already know about comparing Afrezza to competitors' drug---keep in mind, diabetic are required to use other drugs to supplement their use of Afrezza. The same requirement is not required for Afrezza's competitor insulin products. The FDA required this because they had data showing the need for the supplement--this was done based on clinical trial data What other drugs are Afrezza users "required" to take? Basal insulin. |
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Post by sayhey24 on Sept 23, 2022 12:15:11 GMT -5
Investors should hope that at this stage of marketing Afrezza, MNKD will not waste money to find out what they already know about comparing Afrezza to competitors' drug---keep in mind, diabetic are required to use other drugs to supplement their use of Afrezza. The same requirement is not required for Afrezza's competitor insulin products. The FDA required this because they had data showing the need for the supplement--this was done based on clinical trial data What other drugs are Afrezza users "required" to take? None - if they are non-insulin dependent T2s. If we can get to the T2s early there is a pretty great chance they will never be "insulin dependent". And to address this comment "MNKD will not waste money to find out what they already know about comparing Afrezza to competitors' drug" I know I sure don't know what the answers are. What are the results if afrezza went head-to-head again Mounjaro? Have we ever done a head to head against metformin with a CGM? If hopingandwilling knows these answers I sure hope he/she will share. |
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Post by hopingandwilling on Sept 23, 2022 12:48:09 GMT -5
PG--
You suggest the CGMs give away their devices---so where would they get their revenue? Your example of HP giving away ink---only if the user has an HP printer. And FYI---HP can monitor your printer without you knowing it. For example--if you put a non-HP ink cartridge in your printer--automatically you will get a warning that you aren't using a HP ink cartridge. In fact, they can tell you how many pages you have printed in a month. Sorry--there are no secrets with the electronic devices we have in our possession. For example--every Saturday morning when my wife and I have our weekly breakfast together---when I get in my car at the normal 9:00 a.m. when I crank the engine, I get a notice on my screen, telling me the address of the restaurant we go and the mileage away that it is.
Plus, if you are wanting a CGM company to give away their product where they will then be subsidized by another company--that is a federal crime covered under the Sherman Anti-Trust laws. It is called price-fixing! No CGM CEO is going to jail for price fixing!
No CGM manufacturer is going to give a drug company an exclusive for their device---when they can earn and keep every penny, they generate by having the best CGM on the market. The CGMs are in business to make money---for themselves!
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Post by prcgorman2 on Sept 23, 2022 13:15:59 GMT -5
PG-- You suggest the CGMs give away their devices---so where would they get their revenue? Your example of HP giving away ink---only if the user has an HP printer. And FYI---HP can monitor your printer without you knowing it. For example--if you put a non-HP ink cartridge in your printer--automatically you will get a warning that you aren't using a HP ink cartridge. In fact, they can tell you how many pages you have printed in a month. Sorry--there are no secrets with the electronic devices we have in our possession. For example--every Saturday morning when my wife and I have our weekly breakfast together---when I get in my car at the normal 9:00 a.m. when I crank the engine, I get a notice on my screen, telling me the address of the restaurant we go and the mileage away that it is. Plus, if you are wanting a CGM company to give away their product where they will then be subsidized by another company--that is a federal crime covered under the Sherman Anti-Trust laws. It is called price-fixing! No CGM CEO is going to jail for price fixing! No CGM manufacturer is going to give a drug company an exclusive for their device---when they can earn and keep every penny, they generate by having the best CGM on the market. The CGMs are in business to make money---for themselves! Wow. Read slower. The money made from selling disposable elements of a product set can be used to offset, that is subsidize, the basic cost of the non-disposable element of a product set. For quite awhile printer manufacturers were quite nearly giving away printers and making up the difference on selling the ink cartridges. That changed when COVID forced millions of office workers to work remotely from home, and has continued because companies realized productivity did not suffer and worker morale improved and in some cases it is very difficult to get workers unless they are remote, and being remote increases the availability of high quality labor to companies who can accommodate such working conditions, but I digress. Mobile phones were (are?) another example of subsidized costs. The telephone company subsidized (subsidizes?) the cost of the phone to make it cheaper and more enticing for a new subscriber (especially) and makes up the difference in selling usage of airtime. It's why they use contracts, to lock in the profits. agedhippie's point was that few people use CGM readers anymore and instead rely on smart phone applications and either bluetooth or some form of near-field communications radio to send performance information from the sensor to the smart phone (or CGM reader). In this model the CGM is now a sensor and a phone app. My guess is the phone app is free, and the sensor is 100% the source of revenue. To me, the best argument left for giving away starter packs of CGM sensors and subsidizing their cost, then, is from insurance companies who will make up the difference in lowered cost of outcomes, but that's a whole other discussion. |
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Post by agedhippie on Sept 25, 2022 8:50:22 GMT -5
... To me, the best argument left for giving away starter packs of CGM sensors and subsidizing their cost, then, is from insurance companies who will make up the difference in lowered cost of outcomes, but that's a whole other discussion. At this point you run into the short term view of the US insurer. On average you change jobs every four years and with that change often change insurers. Since we are talking about T2 here then there is little risk of ER levels of hypoglycemia so the complications are all at the long term end - far beyond that four year window. Fifteen years down the line when complications are starting they are probably on Medicare now and the government's problem. The problem is that the insurers will only adopt measures that are either required by the SoC, or will save them money in the immediate term. Insurers are for-profit companies and have a legal obligation to put the interests of their shareholders before those of their customer/patients. |
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