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Post by dreamboatcruise on Oct 31, 2017 15:22:35 GMT -5
At this point the issue of when MNKD can/will use STAT results is speculation. I indeed am one that has speculated, and hope, MNKD may have access to the data as soon as it is available and be able to share it under NDA with insurers, international partners, etc., but all that we know is that Univ CO is officially the sponsor and thus in the absence of some agreement with MNKD, they have control over the data. As far as I know management has said nothing about it other than release sometime in 2018, not necessarily early in 2018. |
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Post by babaoriley on Oct 31, 2017 15:27:40 GMT -5
BOOM!! This is a very nice one, combined with the STAT, and the One Drop...I will refer to this as the Afrezza hat trick knockout of the current dinosaurs. Keep 'em coming! Geez, Joey, you finally get a hockey team and already you're using the lingo! |
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Post by babaoriley on Oct 31, 2017 15:30:12 GMT -5
It makes little sense. It says it's a "phase 3" study. Afrezza has completed its phase 3 studies. It also says the patients will be using CGMs, but an exclusion criterion is "Unwilling to test blood glucose before or after each meal." Well, if they're wearing a CGM, they shouldn't need to do that. CGMs are expensive; will MNKD be paying for those? There's no comparison with lispro; what good will it do to show afrezza improves A1c if they don't show it does it better than lispro? As far as "Model Clinical Research," their linkedin page says they have only two employees and their website is dead. The doctor Levin appears to be on this page: www.bayendocrinology.com/physicians.htmlYou seem to always be "digging" in the same place...  |
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Tinkerbell
Researcher
Watcher of the Skies
Posts: 143
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Post by Tinkerbell on Oct 31, 2017 15:35:54 GMT -5
At this point the issue of when MNKD can/will use STAT results is speculation. I indeed am one that has speculated, and hope, MNKD may have access to the data as soon as it is available and be able to share it under NDA with insurers, international partners, etc., but all that we know is that Univ CO is officially the sponsor and thus in the absence of some agreement with MNKD, they have control over the data. As far as I know management has said nothing about it other than release sometime in 2018, not necessarily early in 2018. I keep asking people why they have the opinion that the STAT study won't be done by 1st quarter when slides presented at both conferences in September by MannKind clearly show that this study will be completed by then? Do you have information that the rest of us don't have? If so, please share. |
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Post by dreamboatcruise on Oct 31, 2017 15:45:18 GMT -5
At this point the issue of when MNKD can/will use STAT results is speculation. I indeed am one that has speculated, and hope, MNKD may have access to the data as soon as it is available and be able to share it under NDA with insurers, international partners, etc., but all that we know is that Univ CO is officially the sponsor and thus in the absence of some agreement with MNKD, they have control over the data. As far as I know management has said nothing about it other than release sometime in 2018, not necessarily early in 2018. I keep asking people why they have the opinion that the STAT study won't be done by 1st quarter when slides presented at both conferences in September by MannKind clearly show that this study will be completed by then? Do you have information that the rest of us don't have? If so, please share. Completed is not the same as published. There is often quite some time between completion and publishing. As I have stated multiple times I hope if publication is delayed, such as waiting for ADA, that MNKD can still utilize the data in the interim. Ideally they'd be able to publicize some sort of "top line" results, but what constraints there would be depending on how Univ CO plans to publish the full results is something I do not know. Someone here on PB posted a FAQ which I believe they said came directly from MNKD which states that MNKD does not know when in 2018 STAT results will be released/published, saying Univ CO is the sponsor. |
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Post by seanismorris on Oct 31, 2017 16:03:10 GMT -5
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Post by victoria on Oct 31, 2017 16:45:34 GMT -5
I like this study. The fact its treat to target over just 3 months to me suggests they are pretty confident of the likely results. Its a good population to study since the health consequences of not 'trying something else' after other things have still left the A1c in the 8% to 11% range are serious and hence a significant improvement in that group fills a niche (and in the process establishes the initiation protocol, and sets the agenda for moving afrezza more towards frontline status in other parts of the T2 population. Good move in my view.
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Post by brewguy on Oct 31, 2017 21:20:37 GMT -5
Hmmm...intersting there is only one arm in the study. Why is MNKD still beating around the bush to put it head to head with another prandial insulin? If they ever want to prove superiority this is a must. Many here claim the previous trials were "flawed". So why isn't MNKD jumping to the chance to prove this? Im starting to believe MNKD is afraid they will shoot themselves in the foot if updated study still shows same or even worse results....
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Post by beardawg on Oct 31, 2017 22:02:46 GMT -5
Hmmm...intersting there is only one arm in the study. Why is MNKD still beating around the bush to put it head to head with another prandial insulin? If they ever want to prove superiority this is a must. Many here claim the previous trials were "flawed". So why isn't MNKD jumping to the chance to prove this? Im starting to believe MNKD is afraid they will shoot themselves in the foot if updated study still shows same or even worse results.... I'm thinking, they really don't have to. The studies for other RAAs have already been done. This would just add costs to the trial. If Afrezza performs well, it won't matter what the others do, because doctors already know the results they get with existing RAAs. |
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Post by brewguy on Oct 31, 2017 22:43:21 GMT -5
Hmmm...intersting there is only one arm in the study. Why is MNKD still beating around the bush to put it head to head with another prandial insulin? If they ever want to prove superiority this is a must. Many here claim the previous trials were "flawed". So why isn't MNKD jumping to the chance to prove this? Im starting to believe MNKD is afraid they will shoot themselves in the foot if updated study still shows same or even worse results.... I'm thinking, they really don't have to. The studies for other RAAs have already been done. This would just add costs to the trial. If Afrezza performs well, it won't matter what the others do, because doctors already know the results they get with existing RAAs. For prescribing and insurance purposes, it absolutely matters. When a study comes out showing superiority, this typically results in a huge shift in prescribing practices (i.e. prescribing the superior drug) |
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Post by itellthefuture777 on Nov 1, 2017 0:49:30 GMT -5
Initiating Mealtime Ultra-Rapid Acting Insulin (Afrezza) in Uncontrolled Type 2 Diabetes Patients quote: There's no comparison with lispro; what good will it do to show afrezza improves A1c if they don't show it does it better than lispro? reply: the medical profession is not that keen about putting type two's on subq meal time insulin. if medicine/physicians want to put type two's on subq mealtime insulin, they can. www.screencast.com/t/nOwBa4aaA
Yes, it looks like it may be that this trial is looking at breaking with ADA guidelines and starting people earlier on prandial insulin. In that case there is well established reasons why ADA guidelines are slow to utilize insulin. If this trial can show that Afrezza can be inserted earlier in treatment (six months rather than years) with good results and low risk profile, I don't think it necessary to additionally show what has already been demonstrated regarding RAA vs orals. Afrezza is already mentioned to be able to be started after 6 months if Metformin fails..I imagine this is to become frontline therapy..based in outcomes..not on time..and that new diabestes Type3c..seems to indicate insulin not Metformin should be used first..hmm |
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Post by mnholdem on Nov 1, 2017 5:44:59 GMT -5
It occurs to me that MannKind's objective for this latest trial may be to get the Afrezza titration algorithm approved by the FDA. The algorithm could then be used by Primary Care physicians and even mobile apps for instructing T2 patients. Novo Nordisk and Ely-Lilly have detailed titration algorithms on websites for Novolog and Humalog and there are mobile apps that use these algorithms.
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Post by beardawg on Nov 1, 2017 7:27:48 GMT -5
I'm thinking, they really don't have to. The studies for other RAAs have already been done. This would just add costs to the trial. If Afrezza performs well, it won't matter what the others do, because doctors already know the results they get with existing RAAs. For prescribing and insurance purposes, it absolutely matters. When a study comes out showing superiority, this typically results in a huge shift in prescribing practices (i.e. prescribing the superior drug) I'm sure other companies have already done this same comparison. Their products don't have to be in the same trial in order to show it. You can compare results from existing trials to Mannkind's results and get the same comparison as when you include everything in the trial. Companies do it all the time. for instance, ACHN (and others) did hepC trials to show how many patients achieved elimination of the disease in a specified time after a specified treatment duration. They didn't compare any other drugs, because the other drugs already had published results for the same type of trial. |
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Post by victoria on Nov 2, 2017 4:39:25 GMT -5
Hmmm...intersting there is only one arm in the study. Why is MNKD still beating around the bush to put it head to head with another prandial insulin? If they ever want to prove superiority this is a must. Many here claim the previous trials were "flawed". So why isn't MNKD jumping to the chance to prove this? Im starting to believe MNKD is afraid they will shoot themselves in the foot if updated study still shows same or even worse results.... I think because this study is for people for whom other prandials have already failed and left a1c at over 8%, hence the comparator is inherent in the study relative to other prandials. No other arm needed in this one. |
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