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Post by agedhippie on Apr 19, 2024 10:08:57 GMT -5
Afrezza is a meal time insulin, Levemir is a basal insulin. You cannot replace Levemir with Afrezza as they have different roles. Come on man! Her problem is control. Especially when playing tennis. She is not getting Levemir any more but she can probably use something like Tresiba and not try and control her highs and lows with the basal. Thats afrezza's job after she eats and then its gone. ... This is discussion is beginning to feel like that old saying, if you have a hammer everything looks like a nail. Afrezza will not solve her problem at all. This is nothing to do with eating, it's to do with the interaction between basal insulin and exercise. When you exercise your body burns glucose but your basal insulin still takes the same amount of glucose so there is a deficit and you go low. What she is doing is using Levemir because it is the shortest lasting basal insulin (it lasts about 12 hours) so on days when she is going to play tennis she can take less basal insulin that morning and go back to normal that night (if she was a non-diabetic this would happen automatically). Tresiba would be the worst possible choice for her as it is the longest lasting of all basal insulins, she wants an intermediate basal like Levemir.
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Post by agedhippie on Apr 19, 2024 6:29:19 GMT -5
Sports - I am assuming it is too late to get this girl into the trials but maybe VDex can do something for her? Novo discontinued Levemir and she can't wear a pump playing tennis and can't control her BG with the other basals. It could be some great earned advertising on shows like the View for VDex and afrezza, if afrezza works out for her. More important this girl can probably live a near normal life. www.foxnews.com/health/utah-mom-fights-daughters-access-discontinued-diabetes-medication-life-savingAfrezza is a meal time insulin, Levemir is a basal insulin. You cannot replace Levemir with Afrezza as they have different roles.
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Post by agedhippie on Apr 18, 2024 20:22:49 GMT -5
The rejected motion is on the Bloomberg Terminal courtesy of Bloomberg Law. The headline is " UTC's losses mount in bids to delay Liquidia's rival lung drug". Denying the UTHR motion the judge said that an invalid patent cannot give rise to an injunction. My personal favorite is the footnote the judge wrote "I also doubt that the public interest is served by keeping a drug off the market because of an competitor's expired patent."
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Post by agedhippie on Apr 18, 2024 8:59:13 GMT -5
I would caution how large you go on the dose as a T1. MNKD did a trial on variable carb meals for a fixed dose ( classic.clinicaltrials.gov/ct2/show/results/NCT00747006) and halted the T1 arm after everyone got hypos when they ate 50% of the meal. That is not to say eating 75% of the meal would cause a hypo for a T1, but rather to be careful and see what works for you personally. The T1 world has far less insulin resistance than the T2 world so there isn't the same margin for safety. From the trial: Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 50% carbohydrate load was administered but not completed due to all subjects having hypoglycemia, 0% carbohydrate load was deemed unsafe by PI.Excellent point. Should that difference between T1 use and T2 use be emphasized on the label too? I haven't seen that done before, but it's not a bad idea at all. I am not quite sure how they would do it but maybe expand the Indications and Usage section to point to differing dosing in the Dosage and Administration section?
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Post by agedhippie on Apr 18, 2024 8:49:01 GMT -5
... The most important reason is dosing afrezza is really easy when you stop trying to compare it to subq. The basic rule is "go big" on the dose. For T2s not on subq they are not getting a severe low and for T1s its still kind of hard since afrezza is out so fast. If you have a snack take a small. If you have a big carb meal take a large and then probably follow up dose. Its easy but its been made with the label very complicated. I would caution how large you go on the dose as a T1. MNKD did a trial on variable carb meals for a fixed dose ( classic.clinicaltrials.gov/ct2/show/results/NCT00747006) and halted the T1 arm after everyone got hypos when they ate 50% of the meal. That is not to say eating 75% of the meal would cause a hypo for a T1, but rather to be careful and see what works for you personally. The T1 world has far less insulin resistance than the T2 world so there isn't the same margin for safety. From the trial: Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 50% carbohydrate load was administered but not completed due to all subjects having hypoglycemia, 0% carbohydrate load was deemed unsafe by PI.
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Post by agedhippie on Apr 17, 2024 22:14:01 GMT -5
Why not change the cartridge labels to 2, 4 and 6 units. Diabetics are used to dealing in units. ...or, add a bit more powder and change to 3, 6, 9. More studies, I realize. Those already are in units, just not comparable units to injectibles. It was meant to be a 1:1 conversion but they didn't get it right. It should be a really easy fix though - just a glycemic clamp showing the conversion factor is off. I would have been surprised if it took more than a month to perform + an indeterminate delay for the FDA to revise the label.
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Post by agedhippie on Apr 17, 2024 22:07:44 GMT -5
One again, I tip my hat to you, not even an investor in MNKD, but come here and do this level of research on our behalf, is welcomes and appreciated…🫡🫡 No need for thanks, just happy to help. 🫡
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Post by agedhippie on Apr 17, 2024 19:30:59 GMT -5
It looks like there was something out there I was forgetting, but not on the 19th! There was a court status review today for UTHR's request for an injunction to prevent Yutrepia being used for PH-ILD. As I had expected it went badly for UTHR and they won't be getting the injunction. This is what happens when the judge thinks you are trying to game the system. For me the tell was his earlier comment about plaintiffs using the courts to run down the clock. The ruling will be next week.
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Post by agedhippie on Apr 17, 2024 16:35:40 GMT -5
The refrigeration issue keeps coming up and is one of the most perplexing things about mnkd. A low cost performance test and we have anecdotal evidence that it will pass. Matt covered this ages ago (https://mnkd.proboards.com/post/150435/thread) and talked about what would be involved. It looked cheap to do, but with a long timeline.
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Post by agedhippie on Apr 17, 2024 16:32:02 GMT -5
Aged, any thoughts on what's going on with Yutrepia? I think you mentioned a while back there would be a 2 month delay. We're closer to 3 and I can't help wonder what's going on. Thanks I think the next hearing is the 29th April unless the FDA decides to approve it sooner (I don't think they will) in which case there will be a 3 day warning before approval. I vaguely feel like there was meant to be something on the 19th as well, but I am unsure of that.
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Post by agedhippie on Apr 17, 2024 7:53:54 GMT -5
For what ever reason Oshmyansky was not involved in the discussions. BTW - I have never gotten a box of afrezza shipped. I doubt they refrigerate it. If they do there is no need to except for the bad label. ... You know what I get from my wife now - now who are you talking to. You just never know. We did get an invite to the west wing of the Whitehouse and got some good pictures one time. I think she liked that. What I never knew was why they call the Whitehouse reporters "pool reporters" - the press pool. The Whitehouse briefing "room" is literally over FDR's old pool which Nixon never used so they covered it and the press meet at the pool. So the CEO wasn't involved in the discussions? It cannot have been very serious in that case. Afrezza must be refrigerated for shipping, it's not optional. The label requires, it just like every other insulin, and unless MNKD wants to do the evaluation to prove that Afrezza doesn't require refrigeration (which they won't) that is how it will stay. Someone was pulling your leg over the pool reporter line While the briefing room really is the old swimming pool that isn't why they are are called pool reporters. Pool reporters are members of a press pool and those occur any time that there are more reporters than space. Interestingly FDR was the first president to formalize the press pool at the White House!
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Post by agedhippie on Apr 16, 2024 19:58:16 GMT -5
Mark Cuban looked at insulin before and the killer wasn't the cost of the insulin, they had that nailed down, but rather that insulin has to be shipped refrigerated which pretty much doubled the cost. After the recent price reductions their conclusion was that consumers could get a better deal buying at list price from a pharmacy. I have posted all the numbers before along with comments from his team when asked what happened to the pilot. Afrezza also fails one of their other metric to target established high volume drugs where generics are available. What I can tell you is I had a front row seat. What you are saying I know first hand is not correct but I will leave it at that. You are incorrect and my evidence was in my reply to you the last time you bought this up - mnkd.proboards.com/post/261201/threadThe emphasis is mine since you seem to have missed it before. Dr. Oshmyansky said the company realized it "didn't quite make sense" to sell insulin.
"We were working on bringing in an insulin product to the market for quite some time," he said at the conference. "We did actually bring one to the market, we did it as sort of a closed beta pilot to see what consumer response would be. But ultimately, direct to consumer mail-order it was $35 for a month's supply but $65 for the shipping and handling. It didn't quite make sense within our model. We almost viewed it as a solved problem from the consumer perspective at this point. You know, almost everyone has access to $35 insulin in one form or another now."
What evidence do you have? I am guenuinely curious because I haven't seen anything else on this.
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Post by agedhippie on Apr 16, 2024 17:30:28 GMT -5
Mark Cuban looked at insulin before and the killer wasn't the cost of the insulin, they had that nailed down, but rather that insulin has to be shipped refrigerated which pretty much doubled the cost. After the recent price reductions their conclusion was that consumers could get a better deal buying at list price from a pharmacy. I have posted all the numbers before along with comments from his team when asked what happened to the pilot.
Afrezza also fails one of their other metric to target established high volume drugs where generics are available.
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Post by agedhippie on Apr 16, 2024 17:14:20 GMT -5
Have you considered that patients may not like needing to follow-up dose? That could be a problem that is unfixable. That would be a showstopper for me. I want to minimize my interaction with diabetes, not double it. There is a constituency who would go for the double dosing, but it's not big, and endos would hate it because of the compliance problems. Separately, the pediatrics results cannot be used to change the adult SoC. This is why there are separate adult and child trials.
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Post by agedhippie on Apr 14, 2024 22:34:08 GMT -5
I think it would be very interesting to see the GLP1 results. We know A1c starts to rise again in about a year with the GLP1s. If afrezza can show continued reduction as the GLP1 is failing, I think thats something. I also don't understand why you keep knocking the trial design. I think it was a good one and was put together by the FDA. I do think we should have a 2 year trial head to head with Ozempic but we already know most will stop using Ozempic in a year and we also know for those that don't quite their A1c is probably going to rise. Mike has said in the past that Cipla saw a 1.5-2% A1c reduction. I would like to see the trial results. What GLP-1 results? There are no trials running to compare GLP-1 with Afrezza. The trial is good, it does exactly what is required. The trial is to prove that adding Afrezza to their oral meds is an improvement over adding nothing. I am certain the trial will succeed, no insulin has ever failed this trial!
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