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Post by mytakeonit on Jun 22, 2024 19:29:02 GMT -5
LOL ... I guess you know the answer to that. Problem now is ... do you sell your shares at $10 ... or wait to see if it continues its climb forever. ? I will probably sell my most expensive shares with some cheaper shares to net out a "no taxable gain balance". That will still leave my account with a ton of shares to do whatever/whenever.
And to ktim ... unlike in my younger days where I drank beer or whiskey ... now I drink wine and can drink it without any problem for most of the night.
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Post by sayhey24 on Jun 23, 2024 5:53:21 GMT -5
Afrezza is already rated as non-inferior to RAA, that is part of the insurance problem. Since it is non-inferior today insurers use the equivalence rules and pick an RAA for their meal time insulin. That's just how the system works - Afrezza is far more expensive and insurers want to make a profit. For me the important thing here is less the results and far move the visibility that Afrezza will get. The people they have presenting matter to other endos. That is what will get endos to think maybe they could have the prior authorization fight with the insurer to try Afrezza. The key is to get endos to try it, the rest will follow. Not me. What I want is superiority and fewer severe hypos. We already know thats what afrezza can deliver. The time has come for Mike to deliver. So Aged, what do you think? It seems with the CGM Inhale 3 did better than the one testing site during the 171 when the FDA accused the good doctor of cheating. I think in the past you told us nothing will beat the AID. Inhale 3 PROVES inhaled insulin is as effective as usual care (primarily automated insulin delivery pumps or multiple daily injections) for adults living with T1D meeting the primary endpoint I would say afrezza is actually superior, wouldn't you? Patients utilizing inhaled insulin reached target A1c (less than 7%) 30% of the time compared to 17% with usual care and 24% had time-in-range (TIR) above 70% with no increased hypoglycemia compared with 13% with usual care. Now that sounds pretty damn good. Say what, say hey! I think you have told us T1s don't like to switch a routine which was working. More than 50% of subjects at the end of the study expressed an interest in continuing to use Afrezza® Now thats pretty shocking. I guess I got what I want. Now its time to get some SoC changes. I am also thinking the reason they got the '69 Mets to present the finding is we needed a miracle and it looks like Mike delivered. Maybe Willie Mays is now looking over MNKD. Gone but never forgotten, may he rest in peace. |
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Post by lennymnkd on Jun 23, 2024 6:20:17 GMT -5
Do these results now get presented to
The FDA for possible label changes …..
Black box , possible superiority.. 🤞
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Post by Clement on Jun 23, 2024 6:20:36 GMT -5
Good thread, guys! Thanks!!
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Post by uvula on Jun 23, 2024 7:43:49 GMT -5
Simple question I don't know the answer to.
If a study is designed to prove non-inferiority but ends up showing superiority, can the study sponsors use the study to claim superiority or are they only allowed to say the study proved what the study was designed to prove?
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Post by sportsrancho on Jun 23, 2024 7:51:51 GMT -5
This was under Mannkind’s LinkedIn post in the comments…
CEO/CMO, Digital Marketing, CR...
I don't understand your use of the phrase "is as effective". After I reviewed the study data it was clear that inhaled insulin was superior (by a lot) compared to usual therapy (MDI or pump). "Patients utilizing inhaled insulin reached target A1c (less than 7%) 30% of the time compared to 17% with usual care and 24% had time-in-range (TIR) above 70% with no increased hypoglycemia compared with 13% with usual care." This is amazing news. Congratulations!!
Like Reply • 1 reply
James Lin • 3rd+
5h
Quality Control Analyst Il at Ta...
Suzanne Appel Trial was probably only powered to show non-inferiority instead of superiority, so superior claim cannot be made
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Post by dh4mizzou on Jun 23, 2024 8:04:27 GMT -5
Sports posted "....Suzanne Appel Trial was probably only powered to show non-inferiority instead of superiority, so superior claim cannot be made."
Sorry but to me that's like a soccer team playing for a draw and when they happen to win the referee says the game ended in a draw. Something doesn't smell right.
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Post by letitride on Jun 23, 2024 8:08:29 GMT -5
I liked the way the ADA PR was written better than Mannkinds either way the results are awesome and Im extremely hopeful the 13 week extension is only going to get better. Lets Go!
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Post by agedhippie on Jun 23, 2024 8:16:31 GMT -5
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Post by cjm18 on Jun 23, 2024 8:27:59 GMT -5
The study also found that 19 percent of participants who switched from using an AID system to using inhaled insulin plus degludec achieved an A1C improvement greater than 0.5 percent.
In contrast, 26 percent of the patients in the inhaled insulin group had a worsening of A1C greater than 0.5 percent compared to 3 percent with standard care
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Post by uvula on Jun 23, 2024 8:28:25 GMT -5
Sports posted "....Suzanne Appel Trial was probably only powered to show non-inferiority instead of superiority, so superior claim cannot be made." Sorry but to me that's like a soccer team playing for a draw and when they happen to win the referee says the game ended in a draw. Something doesn't smell right. We don't know if Suzanne is correct, but if she is, it does kind of make sense. Otherwise every clinical trial would have weak claims and then the study sponsor can do the trial and see what happens and make the strongest claim possible by looking at the results. If mnkd was confident, why didn't they go for superiority in this trial? |
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Post by cjm18 on Jun 23, 2024 8:43:20 GMT -5
Sports posted "....Suzanne Appel Trial was probably only powered to show non-inferiority instead of superiority, so superior claim cannot be made." Sorry but to me that's like a soccer team playing for a draw and when they happen to win the referee says the game ended in a draw. Something doesn't smell right. We don't know if Suzanne is correct, but if she is, it does kind of make sense. Otherwise every clinical trial would have weak claims and then the study sponsor can do the trial and see what happens and make the strongest claim possible by looking at the results. If mnkd was confident, why didn't they go for superiority in this trial? Because they weren’t confident? The trial has several secondary measures mentioning superiority. |
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Post by agedhippie on Jun 23, 2024 9:02:44 GMT -5
Do these results now get presented to The FDA for possible label changes ….. Black box , possible superiority.. 🤞 I think a label change is possible down the road as a result of this trial. There was a comment by Dr Hirsch, " The bottom line is we need to understand appropriate dosing for both the inhaled and the basal insulin." You can see why when the bolus to basal ratio is 70:30 rather than 50:50 as those numbers imply that Afrezza is half the strength it claims. Fixing that will stop less experienced endos from under-dosing and wondering why Afrezza doesn't work. So; - I think there will be label changes, but not yet as I suspect they will need more specific trials for that. - Black box will not change as that has nothing to do with Afrezza's effectiveness and is a DPI matter. - Interestingly a lot of the secondary outcomes were collected to show superiority at the 17 week mark but no claims were made over that. For me the main thing was a large number of endos hearing a panel of KOLs say they liked Afrezza and it was useful. This should help dispel some of the FUD that has accumulated over the years. There was a particularly interesting comment in the ADA symposium PR; Moving forward, Dr. Blevins said it will be important to further define guidelines and best practices for the use of inhaled insulin. However, it will ultimately be up to patients and their providers to determine whether the therapy is right for them.That could lead to a consensus on how to use inhaled insulin and potentially inclusion in the SoC. Not soon, but in the future. |
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Post by agedhippie on Jun 23, 2024 9:05:48 GMT -5
I liked the way the ADA PR was written better than Mannkinds either way the results are awesome and Im extremely hopeful the 13 week extension is only going to get better. Lets Go! I really want to see the data from this trial. I suspect that Dr Hirsch will publish his paper in the Diabetes Care so I am eagerly waiting for that. |
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Post by agedhippie on Jun 23, 2024 9:20:33 GMT -5
So Aged, what do you think? It seems with the CGM Inhale 3 did better than the one testing site during the 171 when the FDA accused the good doctor of cheating. ... I think you have told us T1s don't like to switch a routine which was working. More than 50% of subjects at the end of the study expressed an interest in continuing to use Afrezza® Now thats pretty shocking. ... Ten years down the line I would definitely expect we could do better that the 171 trial. As for the rest; show me the data and not a headline. You have a trial population who are not conservative about their routine or they wouldn't be in a clinical trial. That 50% number is not surprising at the end of the trial, but what it doesn't do is breakdown the strength of feeling or the role they see for Afrezza in their future. Is it - yes we will definitely swap, or possibly we will keep some around as a rescue inhaler? Again, data please. |
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