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Post by sayhey24 on Oct 8, 2017 18:38:15 GMT -5
Maybe it will be available in 4u, 8u and 12u cartridges at Starbucks.
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What if?
Oct 8, 2017 19:32:17 GMT -5
od likes this
Post by agedhippie on Oct 8, 2017 19:32:17 GMT -5
What sort of timescale is this over? I ask because nothing has even been filed with EMA for the EU yet so you are probably about two years away from national approvals even if they file tomorrow. China is going to require a manufacturing plan in China so $500 + plant is rather unlikely. I think that the other locations are possible over the next year or two but there will be no deal around those values. Sanofi got the worldwide rights for $150 so that will be the benchmark. I always thought that original deal with Sanofi stunk. And I am not alone with that thought. It was weak given the potential of AFREZZA. And I don't think that Sanofi's $150 will be the benchmark now, imo, nowhere near that! AFREZZA was burdened by a non-inferior label back then when that number was established. Now AFREZZA is proven Superior over all of its competition. Fastest in, Fastest out, no skin irritation like Fiasp, no needles, lower A1C's, no hypos if no basal insulin is used, convienient, etc, etc, etc... That is when the words "game changer" come into play. Things are about to get real interesting for Mannkind and Mankind, and anyone long MNKD! GO MNKD! THE SKY IS THE LIMIT! Well blame Al for the Sanofi deal, obviously it was the best he could get. It's not clear what has changed. As to the improved label; the only things that have changed are that pregnant women can use it (which I happen to think is a good market), and sections 12.2 and 12.3 where there is a nice table giving performance (although not for 8u oddly) and a new performance graph, but without Humalog as a comparison which spoils the effect. What's not in the new label; no claims for reduced hypos, no claims for superiority, no claims for time in range. Now I think time in range gets addressed on the label some time next year given the current trial but right now there is nothing there. The PBM (who are just itching to find a reason why they shouldn't upset their nice juicy insulin contracts), and doctors are going to say that this is all very nice but it has a black box warning for bronchial spasm, cannot be used with smokers or people with breathing/lung issues, even with all this faster onset etc. it still is no better than ordinary RAA, and is more expensive once you add in the need for higher doses. What can be done? Do a proper superiority trial, that's the only thing PBMs cannot shrug off. Get endos to try it - if they get good results they will really push it. Forget about FIasp, that has it's own problem in the B3 incipient. People are not going to be keen because of that. Inject site irritation has existed for as long as I can remember (although I like most people have never had it) - some people are just allergic to a component, with RAA it was often the metacresol. Afrezza has bronchial spam, everything has it's down side. I see FIasp as a way to try to stave off patent expiry for Novolog in the same way Sanofi tried to use Toujeo.
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Post by agedhippie on Oct 8, 2017 19:34:11 GMT -5
Maybe it will be available in 4u, 8u and 12u cartridges at Starbucks. A 4u cartridge would cover a tall latte nicely for me
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Post by straightly on Oct 8, 2017 20:50:13 GMT -5
I always thought that original deal with Sanofi stunk. And I am not alone with that thought. It was weak given the potential of AFREZZA. And I don't think that Sanofi's $150 will be the benchmark now, imo, nowhere near that! AFREZZA was burdened by a non-inferior label back then when that number was established. Now AFREZZA is proven Superior over all of its competition. Fastest in, Fastest out, no skin irritation like Fiasp, no needles, lower A1C's, no hypos if no basal insulin is used, convienient, etc, etc, etc... That is when the words "game changer" come into play. Things are about to get real interesting for Mannkind and Mankind, and anyone long MNKD! GO MNKD! THE SKY IS THE LIMIT! Well blame Al for the Sanofi deal, obviously it was the best he could get. It's not clear what has changed. As to the improved label; the only things that have changed are that pregnant women can use it (which I happen to think is a good market), and sections 12.2 and 12.3 where there is a nice table giving performance (although not for 8u oddly) and a new performance graph, but without Humalog as a comparison which spoils the effect. What's not in the new label; no claims for reduced hypos, no claims for superiority, no claims for time in range. Now I think time in range gets addressed on the label some time next year given the current trial but right now there is nothing there. The PBM (who are just itching to find a reason why they shouldn't upset their nice juicy insulin contracts), and doctors are going to say that this is all very nice but it has a black box warning for bronchial spasm, cannot be used with smokers or people with breathing/lung issues, even with all this faster onset etc. it still is no better than ordinary RAA, and is more expensive once you add in the need for higher doses. What can be done? Do a proper superiority trial, that's the only thing PBMs cannot shrug off. Get endos to try it - if they get good results they will really push it. Forget about FIasp, that has it's own problem in the B3 incipient. People are not going to be keen because of that. Inject site irritation has existed for as long as I can remember (although I like most people have never had it) - some people are just allergic to a component, with RAA it was often the metacresol. Afrezza has bronchial spam, everything has it's down side. I see FIasp as a way to try to stave off patent expiry for Novolog in the same way Sanofi tried to use Toujeo. Mike was very happy when the continous monitor got aoproved. He was not bothered that we did not get the "ultra" in our label. He pointed to "tabel 4". I am not an expert but the link from Peppy putting together Afrezza and Fiasp together screams "Superority" as loud as as any label to me. This is a game changer, and we cannot fall for the "aged" pattern which the other guys will drag us into: unit to unit, we might be only non-inferior. We should simple not play that old game. With Afrezza, patients can be advised to take 4u (or even a 2u?) after a small snake anytime; take a 12u starting a diner, and take another 4u if the pasta turned out to be extra tasty and you want an extra serving. Do that with your needles. In fact, how would you expect FDA even device a plan to show such flexibility? Because THAT is our superority, as shown in tabel 4. I think we already have what we need to market Afrezza as it should be. And advise patients to take it according to what they eat, just like your pancreas does. Simple, but very different that what the needle makes one do. The insurer will be an uphill battle. "Time in range" will be very hard to "prove" in experiments, especially you have to devise a controlled pattern which is NOT how we live. That, I believe, is why Mike is so happy of the approval of the continous monitor. With that, we do not have to device any experiments to show the superiority in the old way anymore. Large volume of data from real patients will show how effective Afrezza can be, used in the way with the amount Afrezza CAN be used. Sanofi cheated on us, probably started with their new CEO. I will not fault Al Mann for trusting a partener as shame is on "you". We will win at the end. The disruption started last Monday.
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Post by peppy on Oct 8, 2017 21:05:08 GMT -5
Superior table. Insurance coverage. Additionally phase 1 and phase two insulin reactions. So now the physicians and patients get to take this label further, with real life results. We already know we have first responders that love afrezza, and say so. They feel better. There is going to be a patient push. Physicians have to give. (insurance baby) apidra tmax is 85 mins.
www.screencast.com/t/dkEveokjM4
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Post by straightly on Oct 8, 2017 21:12:58 GMT -5
Superior table. Insurance coverage. Additionally phase 1 and phase two insulin reactions. So now the physicians and patients get to take this label further, with real life results. We already know we have first responders that love afrezza, and say so. They feel better. There is going to be a patient push. Physicians have to give. (insurance baby) apidra tmax is 85 mins.
Allowing these tables is FDA's way of accepting what MNKD wanted to say for a long time: timing is part of the efficacy, NOT just how hard your insulin can knock the bg down. The game has just changed because we now have a better way to keep scores.
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Post by peppy on Oct 8, 2017 21:13:33 GMT -5
Euphoria is apparently a hallucinogen. I see large populations.
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What if?
Oct 8, 2017 22:14:05 GMT -5
od likes this
Post by agedhippie on Oct 8, 2017 22:14:05 GMT -5
I am not an expert but the link from Peppy putting together Afrezza and Fiasp together screams "Superority" as loud as as any label to me. This is a game changer, and we cannot fall for the "aged" pattern which the other guys will drag us into: unit to unit, we might be only non-inferior. We should simple not play that old game. With Afrezza, patients can be advised to take 4u (or even a 2u?) after a small snack anytime; take a 12u starting a diner, and take another 4u if the pasta turned out to be extra tasty and you want an extra serving. Do that with your needles. In fact, how would you expect FDA even device a plan to show such flexibility? Because THAT is our superority, as shown in tabel 4. I think we already have what we need to market Afrezza as it should be. And advise patients to take it according to what they eat, just like your pancreas does. Simple, but very different that what the needle makes one do. The insurer will be an uphill battle. "Time in range" will be very hard to "prove" in experiments, especially you have to devise a controlled pattern which is NOT how we live. That, I believe, is why Mike is so happy of the approval of the continous monitor. With that, we do not have to device any experiments to show the superiority in the old way anymore. Large volume of data from real patients will show how effective Afrezza can be, used in the way with the amount Afrezza CAN be used. What I am stating is what the opposition will say - we can ignore it but that's just putting our heads in the sand. At the end of the day the trial data is ambivalent at best and the insurers need crystal clear trial data if they are going to increase their costs. I have fought this campaign over CGMs where the data was clear for ages that they reduced people numbers but the insurers would not pay. What finally ended that battle was two big trials that proved once and for all that CGMs worked at which point they caved. We have to get that trial data - no trial data = change. I admire you idea of how diabetics eat and wish we were that disciplined . The problem is that what we do is bolus once for what we expect and that's it. I know my usual helping of pasta is 6u so that is what I bolus. If I then have more I don't bother to bolus again. I know that is bad, I know I shouldn't do it, but I still don't do it and am hard pressed to think of anyone other than a pump user who does bolus (with a pump it's just a button press). Large volumes of data from Afrezza patients would be useful but how do you get it? Insurers will want to know that the sample set is not self-selected (not just the early adopters) but a spread of typical users. Now you have to deal with people who don't accurately log their insulin and carbs, wear CGMs intermittently, and all the messy real world side. That's before you try to deal with the fact that you don't actually have access to the data because of HIPAA. It's not simple sadly.
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Post by patten1962 on Oct 8, 2017 22:32:44 GMT -5
I can see multiple regional partners. 1. UAE, Saudi Arabia, Oman, $100M upfront 2. Canada, $150M 3. Mexico, $150M 4. Australia, $150M 5. Japan with Takeda, $200M 6. India, S Africa with Cipla, $300M 7. China, $500M upfront 8. EU, $300M Mnkd uses the above funding to market A in the U.S. Mnkd's mistake with Sny was not allowing or requiring Sny investing $1B for 10% stake, $500M upfront, 30% royalty, no P/L sharing, $1B milestone bonus. This would keep Sny honest regardless of change of regime. The rumor was Sny's previous CEO wanted to invest in Mnkd. Al turned it down. Wish Al had and watched Shark Tank show where any honest partnership requires a stake. Needless to say Mnkd should have raised $1B in secondary offering when Pps is > $50. I guess There is a remote chance Mnkd could partner in U.S. with a top 10 BP in the world with a deal structured similar to the one above. Mnkd could use the cash to fund TS pipeline. Negotiate from a position of strength! Lakers, what about Brazil? Mike C. Touched on it last call! Would that not be the first place we go overseas?
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Post by straightly on Oct 9, 2017 0:12:07 GMT -5
I am not an expert but the link from Peppy putting together Afrezza and Fiasp together screams "Superority" as loud as as any label to me. This is a game changer, and we cannot fall for the "aged" pattern which the other guys will drag us into: unit to unit, we might be only non-inferior. We should simple not play that old game. With Afrezza, patients can be advised to take 4u (or even a 2u?) after a small snack anytime; take a 12u starting a diner, and take another 4u if the pasta turned out to be extra tasty and you want an extra serving. Do that with your needles. In fact, how would you expect FDA even device a plan to show such flexibility? Because THAT is our superority, as shown in tabel 4. I think we already have what we need to market Afrezza as it should be. And advise patients to take it according to what they eat, just like your pancreas does. Simple, but very different that what the needle makes one do. The insurer will be an uphill battle. "Time in range" will be very hard to "prove" in experiments, especially you have to devise a controlled pattern which is NOT how we live. That, I believe, is why Mike is so happy of the approval of the continous monitor. With that, we do not have to device any experiments to show the superiority in the old way anymore. Large volume of data from real patients will show how effective Afrezza can be, used in the way with the amount Afrezza CAN be used. What I am stating is what the opposition will say - we can ignore it but that's just putting our heads in the sand. At the end of the day the trial data is ambivalent at best and the insurers need crystal clear trial data if they are going to increase their costs. I have fought this campaign over CGMs where the data was clear for ages that they reduced people numbers but the insurers would not pay. What finally ended that battle was two big trials that proved once and for all that CGMs worked at which point they caved. We have to get that trial data - no trial data = change. I admire you idea of how diabetics eat and wish we were that disciplined . The problem is that what we do is bolus once for what we expect and that's it. I know my usual helping of pasta is 6u so that is what I bolus. If I then have more I don't bother to bolus again. I know that is bad, I know I shouldn't do it, but I still don't do it and am hard pressed to think of anyone other than a pump user who does bolus (with a pump it's just a button press). Large volumes of data from Afrezza patients would be useful but how do you get it? Insurers will want to know that the sample set is not self-selected (not just the early adopters) but a spread of typical users. Now you have to deal with people who don't accurately log their insulin and carbs, wear CGMs intermittently, and all the messy real world side. That's before you try to deal with the fact that you don't actually have access to the data because of HIPAA. It's not simple sadly. If anybody think this is going to be simple, then he will be sadly surprised. I happen to work in relevant fields and am seeing positive signs. For example, I know of a national database which gathers all de-identified cystic fibrosis patient data and makes it available to all providers, HIPPA compliant. Even insurers are a changing. I also know, quite recently, an insurance company sign a contract with some community health center to provide "results based care", turning the traditional reimbursement model on its head. They are in there to make money and a lost limb cost the patient dearly also cost an insurer dearly. And they are not stupid either and are doing large data mining more than you would imagine. One promise of large data is that completeness of data will not be a detriment for analysis as long as there is enough data. In fact, Google's BigTable is design to effetive store/process sparse data because traditional relational databases cannot handle so many holes in the data set. Even patients and doctors' attitude are changing. Many are willing to share their data as long as they know what is shared and for what purpose and knowing we are diligent guarding their privacy. Since you are "aged", you surely remember the early days when internet were full of broken links and missing images. But it worked and when more and more people use it, it improves. What I am trying to say is, Afrezza has to be used differently than boluses. Even though one does not bolus more than once does not mean one will not breath twice. It is going to be hard to figure out what is going to be our winning game and we ARE still trying to figure it out. But it is going to be harder to win if we are going to play their game that not suit us. We need to win playing to our strengths, not trying to show we can beat them in their game.
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Post by babaoriley on Oct 9, 2017 1:35:00 GMT -5
If we get a critical mass taking the drug, we're in; trouble is, I don't know what that number might be. A 1,000? 2,000? At some point, if the drug works as well as most of us believe, it will grow rapidly, by word of mouth, diabetic to diabetic, diabetic to doctor, and doctor to doctor, leading to doctor to diabetic.
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Post by lakers on Oct 9, 2017 3:10:34 GMT -5
Aged, the followings should light your bulb. We’ve got the next generation already on the drawing board. They’re very excited to team with the DreaMed group, with their fuzzy logic. So, the next generation algorithm will be, if you’d like it to be, a little bit more aggressive. So, we are excited about that, more automatic bolusing so that the patient is going to be asked to do less and less, and the device will do more and more. We are looking at the use with ultra-rapid-acting insulin to see how far that gets us down the line of not having to inform about an upcoming meal. So very excited about that pathway. we just released in Europe, hopefully in the U.S. pretty soon – a stand-alone sensor and straight to the cell phone. Along with it you’ll be able to get an app that we’ve been collaborating with IBM to have advanced analytics, really big data learning, machine learning, so that patients can start to understand their patterns and trends; see where there might be a problem with their overall management, including a big nutritional component if that’s what they’d like. Read more: mnkd.proboards.com/thread/8688/kaufman-medtronic-ultra-rapid-insulin#ixzz4uBFJh36UIn addition, Castagna said the FDA approved a glucose monitoring system that could spur sales to Type 2 diabetes customers. He said current MannKind sales are evenly split between Type 1 and Type 2 diabetes patients, although 95 percent of overall diabetes patients have Type 2. Being able to check your blood sugar without pricking your finger six or seven times a day will make it easier for people to figure out how to manage their glucose control,” he said. Read more: mnkd.proboards.com/thread/8790/danbury-times#ixzz4uzqLNl7n
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Post by peppy on Oct 9, 2017 5:52:24 GMT -5
If we get a critical mass taking the drug, we're in; trouble is, I don't know what that number might be. A 1,000? 2,000? At some point, if the drug works as well as most of us believe, it will grow rapidly, by word of mouth, diabetic to diabetic, diabetic to doctor, and doctor to doctor, leading to doctor to diabetic. Matt the (vamoose moose) poster told us. 4500 prescriptions a week. I have seen numbers that say 2500 prescriptions a week. OOG's post showing us the weekly market, there seems to be plenty of room for afrezza to take 4500 scripts a week. I believe this rally is about this. (ad nauseam) I believe this is, "the insurance companies will now need to cover afrezza, secondary to demand rally." Additionally, mealtime insulin IS already on the standards of care, now that there is a safe enough mealtime insulin. www.screencast.com/t/nOwBa4aaA
throw into the cake batter, the extra ingredient that afrezza is regular insulin. throw in the plan and size of the world population, www.screencast.com/t/dkEveokjM4 www.screencast.com/t/BtECaauUY9 I see 4500 scripts in our future.
Easy math people? what is the take?
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Post by therealisaching on Oct 9, 2017 8:05:43 GMT -5
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Post by peppy on Oct 9, 2017 8:13:06 GMT -5
and what if china sees; insulin regular as over the counter, and inhalation administration requiring less refrigeration as superior?
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