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Post by agedhippie on Aug 11, 2024 10:37:09 GMT -5
Looks like a Dexcom G7. At the moment he is in his honeymoon phase, which is why they didn't know he had diabetes, so he will be taking minimal insulin.
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Post by agedhippie on Aug 10, 2024 19:15:17 GMT -5
... I constantly wonder when will our healthcare model move away from favoring treatment and start working toward prevention? Sounds like a VDEX type approach, without the doctors or focus no medication. She really underscored what we on this board already know, which is T-1s do not get the education they really need from the current healthcare system to combat this disease. ... This New York Times article is well worth reading: In the Treatment of Diabetes, Success Often Does Not Payhis article is a bit old now, but still valid. It describes how the diabetes clinics in New York largely died. At core the insurers do not reimburse the hospital systems at a rate that covers their costs. The insurers don't believe they will be holding the baby when the music stops so there is no incentive to pay.
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Post by agedhippie on Aug 10, 2024 11:09:14 GMT -5
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Post by agedhippie on Aug 9, 2024 13:40:05 GMT -5
... Gestational This will show superiority as long as the future moms dose properly. ... It will show superiority as they have scoped it to just a standardized meal test over the first two hours and they have done that trial several times before. This trial is about showing that Afrezza is safe to use during pregnancy (currently it's not approved if you are pregnant.) I don't see this trial have much impact in itself (all the insurance issues will still apply), but what it will do is unlock the second trial comparing Afrezza and RAA over a longer period - the trial Carol Levy wants to do. The longer trial could change insurance cover for pregnant women.
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Post by agedhippie on Aug 9, 2024 13:30:02 GMT -5
sayhey24 - I don’t like to dwell on cost and insurance, but those are still important hurdles. I don’t know how much Afrezza costs to make, so I don’t know how much product would have to sell to be able to drop the price close to cost and make up the difference in volume, but I hope it’s low enough for Afrezza to be sold at a low premium to RAA (less than twice as much?). I don’t know what the sweet spot is there or how to reach it (maybe pilot pricing in regions?) but I think its critical. I think you are going in the opposite direction to Mike "Afrezza net revenue of $16 million grew 20% versus second quarter 2023 which was primarily driven by volume growth, a lower gross to net percentage of 37% versus 39% in the prior year, and a price increase." MNKD aren't reducing the price of Afrezza, they are increasing it.
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Post by agedhippie on Aug 7, 2024 12:10:45 GMT -5
There's a huge difference between GAPP earnings and non-GAAP. I would like to understand this better. GAAP is the gold standard, non-GAAP leaves out some expenses. The problem with non-GAAP is that the omissions can vary from report to report. Commonly they will leave out one off expenses, I suspect it this case it's related to settling those debts but I couldn't tell without reading the report. Lots of companies use non-GAAP metrics and the market usually treats those numbers as marketing.
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Post by agedhippie on Aug 7, 2024 11:50:19 GMT -5
^ "This single registrational study, identified as ICoN-1, anticipates getting underway by end of 2Q 2024 in the U.S., and internationally in the second half of 2024." PMDA is Japan's pharmaceuticals and medical devices agency. Normally, PMDA does not rubber-stamp an FDA approval. PMDA has its own procedures and requirements. So, Japan will eventually require its own submission of final trial results to obtain approval. FDA and Japan have aligned for a single trial? Was that known? Or something new from the quarterly report? I mean that is great news as the process through Japan should be even swifter. The FDA approval will not be valid in Japan hence that phrasing about "require its own submission of final trial results". It's the same trial though. From memory this is a two center trial with one of the centers being in Japan which is why they can do this (the PMDA wants to know the drugs will work on Japanese people specifically).
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Post by agedhippie on Aug 4, 2024 22:18:13 GMT -5
Carol Levy is running the trial at the New York location (there are five locations.) The trial is scoped to the 2hr mark so the outcome is predictable.
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Post by agedhippie on Aug 3, 2024 9:45:51 GMT -5
It was the nebulized version. They probably didn't want to use TS because the black box label would have caused delays with getting the trial up and running. It's simpler to start with the nebulized version and if it works do a transition trial for TS.
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Post by agedhippie on Aug 2, 2024 22:36:51 GMT -5
That argument persuades me, and I don’t know why it isn’t more persuasive generally. I assume and believe poorly controlled or uncontrolled BG spikes cause harm, insidiously, slowly, over time. The question is how much damage and what kind, and would Afrezza help in real life as opposed to theoretically (for which you need trial data). This is why GLP-1 pharmas have all been industriously doing trials to show GLP-1 will improve cardio and kidney risk - it's quantified so you can sell on it (you are required to have trial data or the FDA will have words with you).
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Post by agedhippie on Aug 2, 2024 22:28:21 GMT -5
And as I said it's utterly irrelevant as the patients will all be on basal and thus covered for CGMs. Icodec failing to get approved doesn't change that one bit, the CGM makers still get the sales. 6 or 8 years later??? Are you kidding me. Robert Frost does not want to wait 6 or 8 years and then have these people die in 5 years from a heart attack. Get them the afrezza day 1 and get the CGM sales too. I am pretty sure getting them afrezza day 1 will also stop the progression and many will not have the cardo issues. I am not sure what you are mean by 6 to 8 years, time to insulin today? If that's what you mean then I think you rather miss the point. Right at this moment there are a continuous stream of Type 2 patients hitting the point where they require insulin and get a CGM, there is no 6 to 8 year lag on sales. "I am pretty sure" is not the same as can be proven. Pretty sure is just opinion and you are not going to get any traction at all with opinion. Come back when there is trial data to show reduced cardio issues like they have done with GLP-1.
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Post by agedhippie on Aug 2, 2024 22:20:04 GMT -5
PCPs will follow the SoC and prescribe basal before they prescribe meal time insulin, just the same as endos do. So. Mike needs to get that changed. If Inhale-2 is as good as he has said he has the trial data. Abbott needs insulin prescribed earlier in the T2 life-cycle. ... If the CIPLA results are as good as he says they will only be slightly worse than Mounjaro. Abbott needs CGMs approved for non-insulin users and then they have all diabetics covered, which is what they are focused on right now.
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Post by agedhippie on Aug 2, 2024 15:48:33 GMT -5
To the best of my knowledge Medicare will not cover CGMs for non-insulin users although some insurers will. Abbott are already presenting their finding showing the benefit of CGMs for GLP-1 users at international conferences. I remember you saying there is no way Medicare will ever cover CGMs for basal insulin using T2 just before Medicare approved exactly that. That was also all driven by trial data. We are talking T2s on Medicare for Abbott. That is their focus not the broader market for now. As I said before they had the studies ready to go with icodec buts thats DOA now. .... And as I said it's utterly irrelevant as the patients will all be on basal and thus covered for CGMs. Icodec failing to get approved doesn't change that one bit, the CGM makers still get the sales.
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Post by agedhippie on Aug 2, 2024 15:43:52 GMT -5
The issue is that the CGM salesman is there to sell a tool, not change diabetes treatments (that's the endos' job). The endo is going to prescribe that CGM regardless if the patient is on insulin. There is no up side for the CGM vendor in presenting Afrezza. Most T2s don't go to endo's. The upside for the Abbotts is they need insulin prescribed to get the CGM sale. Afrezza fits nice with the PCP as there is little fear with hypos and no needles. Afrezza is just too damn expensive right now which insurance can fix. PCPs will follow the SoC and prescribe basal before they prescribe meal time insulin, just the same as endos do.
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Post by agedhippie on Aug 2, 2024 13:40:37 GMT -5
... I don't know if they will get Medicare to pay for the CGMs with GLP1 users. I see little benefit but its all about Abbott selling Libres. I am sure they have all kinds of studies showing amazing benefits but in real life, I don't see it. What I do see is the CGM will highlight the spike and need for afrezza. ... To the best of my knowledge Medicare will not cover CGMs for non-insulin users although some insurers will. Abbott are already presenting their finding showing the benefit of CGMs for GLP-1 users at international conferences. I remember you saying there is no way Medicare will ever cover CGMs for basal insulin using T2 just before Medicare approved exactly that. That was also all driven by trial data.
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