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Post by sayhey24 on Nov 5, 2021 11:50:06 GMT -5
I would think if Tyvaso does not contain the black box, which it seems it won't, I think Mike will go for a whole new label to redo the dosing and eliminate the black box. Hey Sayhey, are you saying that MNKD may request a new label with no black-box and justify it with this study? Do you think that a 20-patient study is enough to compel the FDA? If so, that would be sweet. No. The black box has nothing to do with this study. The black box is for acute bronchospasm. It says "acute bronchospasm has been observed in patients with asthma and COPD using AFREZZA". In 6 years I have not heard of acute bronchospasm as being an issue, have you? The theory back in the day was TS was going to cause this. That same TS is what is being used by Tyvaso and if the label does not change from the CRL, it does not contain this warning. This study is about dosing. One of the big hits on afrezza by some is "it doesn't work". Well, that's because they are under-dosing. I have said this in the past that IMO the biggest marketing mistake Al Mann ever made was calling the capsules 4/8/12 units. He should have called them small, medium and large so no one would try and compare them to their current RAA. Going for a label change is not cheap. I would hope they not only fix the dosing but ask for the black box to be removed. |
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Post by peppy on Nov 5, 2021 11:55:32 GMT -5
Hey Sayhey, are you saying that MNKD may request a new label with no black-box and justify it with this study? Do you think that a 20-patient study is enough to compel the FDA? If so, that would be sweet. No. The black box has nothing to do with this study. The black box is for acute bronchospasm. It says "acute bronchospasm has been observed in patients with asthma and COPD using AFREZZA". In 6 years I have not heard of acute bronchospasm as being an issue, have you? The theory back in the day was TS was going to cause this. That same TS is what is being used by Tyvaso and if the label does not change from the CRL, it does not contain this warning. This study is about dosing. One of the big hits on afrezza by some is "it doesn't work". Well, that's because they are under-dosing. I have said this in the past that IMO the biggest marketing mistake Al Mann ever made was calling the capsules 4/8/12 units. He should have called them small, medium and large so no one would try and compare them to their current RAA. Going for a label change is not cheap. I would hope they not only fix the dosing but ask for the black box to be removed. I agree with every word sayhey. However, the slow sales is we need afrezza health insurance coverage added. I don't think the Endos really care subq or inhaled. What they want is a smoothly run office with insurance coverage and no calls from the pharmacy, or the health insurer. A bit like being tolerant of insurrection. We seem to be trained seals. |
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Post by MnkdWASmyRtrmntPlan on Nov 5, 2021 12:22:56 GMT -5
Hey Sayhey, are you saying that MNKD may request a new label with no black-box and justify it with this study? Do you think that a 20-patient study is enough to compel the FDA? If so, that would be sweet. No. The black box has nothing to do with this study. The black box is for acute bronchospasm. It says "acute bronchospasm has been observed in patients with asthma and COPD using AFREZZA". In 6 years I have not heard of acute bronchospasm as being an issue, have you? The theory back in the day was TS was going to cause this. That same TS is what is being used by Tyvaso and if the label does not change from the CRL, it does not contain this warning. This study is about dosing. One of the big hits on afrezza by some is "it doesn't work". Well, that's because they are under-dosing. I have said this in the past that IMO the biggest marketing mistake Al Mann ever made was calling the capsules 4/8/12 units. He should have called them small, medium and large so no one would try and compare them to their current RAA. Going for a label change is not cheap. I would hope they not only fix the dosing but ask for the black box to be removed. Oh, right. The blackbox is for bronchospasms. So, does that mean that all TS products (Afrezza, Tyvaso dpi, etc.) would either carry the black box or not. So, if Tyvaso DPI got approved without the BB, then T-DPI would also get its BB removed? That would be very cool. No, I have not heard of any bronchospasms with Afrezza. I also totally agree with the small medium and large idea. I also think those size names could be changed anytime going forward with very little marketing glitches. |
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Post by sportsrancho on Nov 5, 2021 13:16:39 GMT -5
If you at last get the dosing correct you won’t have the churn!! That’s why Vdex has over 80% retention ..and where did Bill learn it …from Al❣️
People quitting every day on the Afrezza Facebook page because they think it doesn’t work, because they’re not taking enough.
You get the dosing right and the patient’s results will speak for themselves. This will help insurance.
Vdex has other studies in mind😉
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Post by uvula on Nov 5, 2021 13:21:56 GMT -5
Sounds like mc should have listened to vdex years ago.
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Post by Chris-C on Nov 5, 2021 13:41:48 GMT -5
The dosing issue is a major factor and should have been tackled years ago. Are people afraid to dose up?
I checked the FAERS FDA reporting system for adverse events associated with Afrezza use since its inception. So far in 2021, there have been 3 reports, that's correct: THREE. Since its inception in 2015, there are 443 adverse events reported. Acute bronchospasm is not specifically listed, but given the occasions of use, which we can assume is in the hundreds of thousands since inception, it appears that acute bronchospasm has not been a widespread phenomenon. There have been 4 deaths reported, one of which was a suicide where Afrezza use was not the sole method of self harm used by the decedent. Hypoglycemic reports are extremely rare (as we would expect.)
On the other hand, comparing a rapid acting insulin analog like Humalog. for example, shows much greater occurrences of adverse events, with over 10,000 since inception and over 100 deaths since 2015 alone. I acknowledge that all of this is difficult to untangle because there are so many comorbidities and behavioral issues at play that can lead to adverse events and deaths. But just looking at the reporting data, I'd conclude that the safety profile of Afrezza should not be of concern to potential users or prescribers. All in my humble opinion, of course, with acknowledged conflict of interest because I am an investor. As always, it is wise for investors and patients to do their own due diligence.
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Post by stevil on Nov 5, 2021 16:17:33 GMT -5
Do you think that a 20-patient study is enough to compel the FDA? If so, that would be sweet. This was a feasibility study. It looks like they'll probably do a larger study later on. I wouldn't expect any changes to be made based off of this info. This small study was done to help determine if and how a larger study should be done to get the desired results. The results of the larger trial will be the ones that should make waves. |
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Post by sayhey24 on Nov 5, 2021 17:46:42 GMT -5
The dosing issue is a major factor and should have been tackled years ago. Are people afraid to dose up? I checked the FAERS FDA reporting system for adverse events associated with Afrezza use since its inception. So far in 2021, there have been 3 reports, that's correct: THREE. Since its inception in 2015, there are 443 adverse events reported. Acute bronchospasm is not specifically listed, but given the occasions of use, which we can assume is in the hundreds of thousands since inception, it appears that acute bronchospasm has not been a widespread phenomenon. There have been 4 deaths reported, one of which was a suicide where Afrezza use was not the sole method of self harm used by the decedent. Hypoglycemic reports are extremely rare (as we would expect.) On the other hand, comparing a rapid acting insulin analog like Humalog. for example, shows much greater occurrences of adverse events, with over 10,000 since inception and over 100 deaths since 2015 alone. I acknowledge that all of this is difficult to untangle because there are so many comorbidities and behavioral issues at play that can lead to adverse events and deaths. But just looking at the reporting data, I'd conclude that the safety profile of Afrezza should not be of concern to potential users or prescribers. All in my humble opinion, of course, with acknowledged conflict of interest because I am an investor. As always, it is wise for investors and patients to do their own due diligence. Are people afraid to dose up? They are scared to death. Insulin is viewed as dangerous because of hypoglycemia. It can kill you. The rule of thumb and in practice with subq is to under dose and let the BG run high. Thats the reason 170 mg/dl has been held as the target# for most subq insulin users. Thats an A1c of 7.5 For TIR what are they using, 180? When you see the TV commercials for the T2 meds getting under 7 is the holy grail. Thats an average BG of 154 and we know having a BG over 140 for 2+ hours starts to cause vascular degeneration. The view is its better to let them die of a heart attack in 10 years than to die of hypoglycemia today. Then Al Mann shows up with his afrezza and tells the medical community that he has a way to take insulin without the worry of severe hypos. He is telling an industry which has $B's in sales of T2 meds we don't need them any more and we can do much better. All you need to do is use afrezza as the first and only step with T2s. If I remember correctly Al got into it in public one day with Ralph DeFronzo who pretty much called him a liar. Now Ralph is a smart guy but he has one firm belief - insulin is dangerous and a last resort. Al saying not to worry about serve hypos when not taking other meds blew Ralph's mind and probably threatened his project funding. At the same time Ralph is the guy who said this “The most waste in type 2 diabetes is to continuously put people on metformin and sulfonylureas (glyburide, glimepiride, etc.). These drugs have no protective effect on the beta cell, and by the time you figure out what you’re doing, there are no beta cells left to save.” – Dr. Ralph DeFronzo (University of Texas Health Science Center) diatribe.org/the-diatribe-foundation-and-tcoyd-11th-annual-forum |
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Post by radgray68 on Nov 5, 2021 20:11:17 GMT -5
I believe I remember Mike said new, more aggressive dosing protocols will be implemented in the pediatric trials. That'll be a whole lot more than 20. I don't know how they'll go about dosing the Indian trial because I think that's based on a single large meal a day. But, it would seem logical that one large meal should get one large dose at the beginning.
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Post by sportsrancho on Nov 6, 2021 8:57:56 GMT -5
I just put a ad/post up in a Afrezza FB group for Vdex’s Telehealth.
16 likes and 5 comments within 12 hours.
People reaching out because they either can’t get a prescription from their Endo or their insurance has denied them or they feel like Afrezza isn’t working because they don’t have the dosing right.
We are covered by their insurance, Medicare etc.
After they get a breath test we can give them a prescription over the phone.
We can work with them to get their numbers down, send them samples, and appeal to their insurance company.
The protocols and the dosing and the CGM all have to come first.
A lot of times we eat the cost of the CGM and send them one, teach them how do use it then get them on Afrezza. Get the dosing right, get their numbers down, and appeal the insurance.
This is a long process but then you’ve got a patient for life. They then understand the science.
Dosing is key and this is a great step in the right direction.
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Post by patten1962 on Nov 6, 2021 9:01:09 GMT -5
I just put a ad/post up in a Afrezza FB group for Vdex’s Telehealth. 16 likes and 5 comments within 12 hours. People reaching out because they either can’t get a prescription from their Endo or their insurance has denied them or they feel like Afrezza isn’t working because they don’t have the dosing right. We are covered by their insurance, Medicare etc. After they get a breath test we can give them a prescription over the phone. We can work with them to get their numbers down, send them samples, and appeal to their insurance company. The protocols and the dosing and the CGM all have to come first. A lot of times we eat the cost of the CGM and send them one, teach them how do use it then get them on Afrezza. Get the dosing right, get their numbers down, and appeal the insurance. This is a long process but then you’ve got a patient for life. They then understand the science. Dosing is key and this is a great step in the right direction. Thank you for everything you and Vdex does! |
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Post by sweedee79 on Nov 6, 2021 10:19:34 GMT -5
Hey Sayhey, are you saying that MNKD may request a new label with no black-box and justify it with this study? Do you think that a 20-patient study is enough to compel the FDA? If so, that would be sweet. No. The black box has nothing to do with this study. The black box is for acute bronchospasm. It says "acute bronchospasm has been observed in patients with asthma and COPD using AFREZZA". In 6 years I have not heard of acute bronchospasm as being an issue, have you? The theory back in the day was TS was going to cause this. That same TS is what is being used by Tyvaso and if the label does not change from the CRL, it does not contain this warning. This study is about dosing. One of the big hits on afrezza by some is "it doesn't work". Well, that's because they are under-dosing. I have said this in the past that IMO the biggest marketing mistake Al Mann ever made was calling the capsules 4/8/12 units. He should have called them small, medium and large so no one would try and compare them to their current RAA. Going for a label change is not cheap. I would hope they not only fix the dosing but ask for the black box to be removed. Not only that but when Afrezza first came out the instruction pamphlet that came with the script said a unit of Afrezza was the same as a unit of RAA.. I don't know what is says now.. but huge mistakes were made initially marketing Afrezza.. Consequently Afrezza didn't work as good as we all know it does.. so it's no wonder so many quit using it.. not to mention the vast lack of insurance coverage .... Advertising to the mass market would never been successful under these circumstances... I knew this and kept saying this but nobody would listen.. and there were problems with docs not wanting to deal with it as well... Why would they when our label said noninferior..
Too many mistakes were made.. we know now.. but our reputation has already been damaged.. what will it take to fix this? I don't know, I haven't seen anything so far that has worked.. really hope they can, but it seems large trial data is what we need.. and Vdex..
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Post by Chris-C on Nov 7, 2021 10:44:43 GMT -5
I just put a ad/post up in a Afrezza FB group for Vdex’s Telehealth. 16 likes and 5 comments within 12 hours. People reaching out because they either can’t get a prescription from their Endo or their insurance has denied them or they feel like Afrezza isn’t working because they don’t have the dosing right. We are covered by their insurance, Medicare etc. After they get a breath test we can give them a prescription over the phone. We can work with them to get their numbers down, send them samples, and appeal to their insurance company. The protocols and the dosing and the CGM all have to come first. A lot of times we eat the cost of the CGM and send them one, teach them how do use it then get them on Afrezza. Get the dosing right, get their numbers down, and appeal the insurance. This is a long process but then you’ve got a patient for life. They then understand the science. Dosing is key and this is a great step in the right direction. It seems that VDEX has a solid approach to managing diabetes that more than pays for itself through how it enables PWDs to understand and easily (and properly) self-manage their disease. That said, I imagine that a sizable percentage of folks with T2 don’t want to bother with understanding and taking control of their illness- they just want to take a pill, which suggests only a certain segment of the diabetic population are prospects for the clinical program. But even if that number is 15-20%, that’s huge for Afrezza if it can be achieved. MC needs to notice this, IMO. |
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