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Post by Deleted on Aug 7, 2017 7:55:26 GMT -5
A more useful study would have 3 arms: afrezza with one drop, metformin with one drop, or one drop by itself. Maybe this was too risky because mnkd might not get the results they want. You are overseeing a VERY IMPORTANT thing the fact that one drop is just a monitoring tools for better management of you HA1C; Hence there is no need to mention others insulin type. This trial is Inhaled insulin again the other insulin option. One drop assist a patient in monitoring and the patient need INSULIN. So this trial is design to Compare the use of one-drop with Afrezza or without meaning one-drop with any others form insulin I say smoke and mirrors. And while we are lapping up this so called partnership we are going to get hit dilution. I only pray Mike has the juevos to be frank and upfront with us about the direction of Afrezza 3.0. I expect heavy dilution. Cash is needed. A partnership that does not help our situation is only a distraction at this point. Anyone who disagrees has to be smoking some righteous sh!t.
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Post by akemp3000 on Aug 7, 2017 7:57:38 GMT -5
Mannkind would have likely preferred a comparison study using One Drop and various other drug solutions but great results using Afrezza would benefit Mannkind far more than One Drop. As a CBGM solution provider, it's in One Drop's best interest to be preferred for use with ALL drug options available on the market. They will have enough competition as it is from other CBGM providers. They don't need other drug companies to turn against them. If the results show diabetics staying within range when using Afrezza, which we already know to be true anecdotally, this study will establish a new standard of care for diabetics that can be shared with prescribers. Others drug companies will then need to prove they can match the results and that will be difficult. This is good news and the sooner, the better to hear the results.
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Post by jonny80s on Aug 7, 2017 8:04:15 GMT -5
Why was this even announced pre earnings release? It's a non-event. No money.
Just a startup with little money and an 11 year old company with no money grasping in desperation.
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Post by uvula on Aug 7, 2017 8:04:15 GMT -5
One Drop is not a CBGM, it is a BGM. Uses test strips. Big difference. It cannot compete with CGMs except that it is cheaper.
The only way to show how fast afrezza acts is with a CGM. This entire collaboration with One Drop instead of a real CGM company smells like desperation for MNKD and One Drop.
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Post by agedhippie on Aug 7, 2017 8:04:19 GMT -5
Mannkind would have likely preferred a comparison study using One Drop and various other drug solutions but great results using Afrezza would benefit Mannkind far more than One Drop. As a CBGM solution provider, it's in One Drop's best interest to be preferred for use with ALL drug options available on the market. They will have enough competition as it is from other CBGM providers. They don't need other drug companies to turn against them. If the results show diabetics staying within range when using Afrezza, which we already know to be true anecdotally, this study will establish a new standard of care for diabetics that can be shared with prescribers. Others drug companies will then need to prove they can match the results and that will be difficult. This is good news and the sooner, the better to hear the results. You would need a trial and not a study to accomplish a change in the standard of care. Ditto to get any movement from the insurers. As it stands this is an in-house study so it carries little weight in the outside world. What it will do is help One Drop optimize their coaches scripts for both Afrezza and non-insulin users.
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Post by derek2 on Aug 7, 2017 8:04:57 GMT -5
This really reminds me of the Affinity 2 trial, where the arms were:
[Oral med + Lifestyle & diet coaching] vs. [Afrezza + Oral med + Lifestyle & diet coaching] in T2s
In the Afrezza arm, A1c dropped by 0.8% In the comparator arm, A1c dropped by 0.4%
Giving a net effect from Afrezza of 0.4%
Many complained that the trial design didn't allow Afrezza to work to best effect. Well, this new trial should give insight into using the titration, dosing. and timing lessons that have been learned in the last 4 years. Should be interesting!
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Post by agedhippie on Aug 7, 2017 8:10:11 GMT -5
This really reminds me of the Affinity 2 trial, where the arms were: [Oral med + Lifestyle & diet coaching] vs. [Afrezza + Oral med + Lifestyle & diet coaching] in T2s In the Afrezza arm, A1c dropped by 0.8% In the comparator arm, A1c dropped by 0.4% Giving a net effect from Afrezza of 0.4% Many complained that the trial design didn't allow Afrezza to work to best effect. Well, this new trial should give insight into using the titration, dosing. and timing lessons that have been learned in the last 4 years. Should be interesting! Those trials used randomized groups, the One Drop exercise uses self-selecting Afrezza users. The Afrezza users are motivated to make this work, the trial Afrezza users were just users and as such not highly motivated. You would not be comparing like with like.
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Post by peppy on Aug 7, 2017 8:20:58 GMT -5
reading some accounts from T2's their HgA1c 10 and 11 going down to 7 on afrezza. I just read a discussion that was linked; diabetes talking to each other, a discussion about Hga1c's and afrezza. where was it? I have been surprised by T2's. I have been surprised at how much insulin they need. I have been surprised to hear what their HgA1c were/ are running.
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Post by sportsrancho on Aug 7, 2017 8:21:49 GMT -5
You all kept asking what was going on with both party's working together.
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Post by peppy on Aug 7, 2017 8:24:13 GMT -5
look at the time, 7 mins to the open and no pr. 8q. After the close? huh?
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Post by uvula on Aug 7, 2017 8:24:59 GMT -5
You all kept asking what was going on with both party's working together. We are still asking. It sounds like the answer is that not much was going on. "Hey, let's do a study". "Okay".
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Post by lb on Aug 7, 2017 8:27:32 GMT -5
Yea, but you don't look into given horse's mouth. If OneDrop pays the most for the studies, proves a superior solution, and advertises to their customer base, that's also all-in-one solution for MNKD: free advertisement and free (or almost free) trials.
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Post by agedhippie on Aug 7, 2017 8:47:44 GMT -5
look at the time, 7 mins to the open and no pr. 8q. After the close? huh? After the CC ?
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Post by thall on Aug 7, 2017 9:00:38 GMT -5
I rather see them launch the pediatrics or even the safety trial.
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Post by casualinvestor on Aug 7, 2017 9:08:52 GMT -5
From the article:
One-Drop isn't interested getting in the middle of a competition between different treatments for diabetics. Why should they? They want to grow their business of helping PWDs by proving that they get results.
If, for example, that study shows a greater A1c drop and more time in range with Afrezza than just coaching, then they have a basis on which to launch an Afrezza-based service. The study will also help them get more coaches trained up on methods for using Afrezza
We've seen before that many people really need coaching to make Afrezza work at the start. One-Drop looks like it's willing to be that coach. They're also collecting motivated PWDs. This is good news, but will take 3 months to show results.
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