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Post by cathode on May 16, 2016 11:37:26 GMT -5
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Post by kc on May 16, 2016 12:03:22 GMT -5
Looks like they will have plenty of opportunity to education attendees on the benefits of Afrezza. The difficult thing is for a attendee to fit everything into their schedule. So hopefully they will have some full class rooms but it does take time to get the product launched and moving again. So the attendees will be a start to the education process but this is an Ultra-Marathon event and will take 12 to 18 months to see it come to fruition.
But I do like the topics of the papers especially this one: Technosphere® Inhaled Human Insulin Has a More Rapid Onset of Action Than Subcutaneous Insulins:
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Post by dg1111 on May 16, 2016 12:17:59 GMT -5
Is the title the conclusion of the study or the intent of what the study is trying to prove? A study with data to conclude that "Technosphere® Inhaled Human Insulin Has a More Rapid Onset of Action Than Subcutaneous Insulins" or "Technosphere Insulin Inhalation Powder (TI) Displays Earlier Onset and Shorter Duration than Insulin Lispro (Lispro)" would certainly help. The other titles are not as telling, but if "The Impact of Baseline Lung Function on Outcomes with Inhaled Technosphere Insulin (TI)" shows that lung function is not adversely effected by Afrezza, that would help too.
I am optimistic about what these studies may bring, but the clock is definitely ticking right now.
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Post by mnholdem on May 16, 2016 12:34:56 GMT -5
Afrezza was determined by FDA to be non-inferior to lispro, but this data should be marketable as a rebuttal.
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Post by Deleted on May 16, 2016 13:00:37 GMT -5
Thanks for sharing. Does anyone have any experience with the title and what is actually spoken about? I have to admit these topics are more exciting then I expected.
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Post by Deleted on May 16, 2016 13:31:30 GMT -5
Can MNKD share these with potential partners?
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Post by 4allthemarbles on May 16, 2016 13:36:04 GMT -5
They are about to share them with the world (in about a month). Hopefully potential partners will be at the presentation and not some free food gala sponsored by Sanofy...
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Post by kc on May 16, 2016 13:52:32 GMT -5
They are about to share them with the world (in about a month). Hopefully potential partners will be at the presentation and not some free food gala sponsored by Sanofy... You can bet that all the competitors will be filling the room listening to the presentation and then trying to figure out what to do next in competing with MannKind. Perhaps only one of the will get it correctly and do the right thing for their future.
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Post by mnholdem on May 16, 2016 13:52:58 GMT -5
Can MNKD share these with potential partners? I believe that the ADA rules governing these abstracts does allow the information to be shared. It would likely be under a Non-Disclosure Agreement anyway, but MannKind has the full reports in their possession.
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Post by Deleted on May 16, 2016 13:56:26 GMT -5
thanks mnholdem
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Post by brotherm1 on May 16, 2016 14:02:49 GMT -5
So to be perfectly clear: Are these absracts the result of completed studies that were approved by the FDA and will the results of these studies be able to be listed on the drug packaging/inserts? Sorry to ask so many questions.
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Post by peppy on May 16, 2016 15:33:51 GMT -5
So to be perfectly clear: Are these absracts the result of completed studies that were approved by the FDA and will the results of these studies be able to be listed on the drug packaging/inserts? Sorry to ask so many questions. The only study I know was completed: clinicaltrials.gov/ct2/show/NCT02470637
931-P / 931 - Technosphere® Inhaled Human Insulin Has a More Rapid Onset of Action Than Subcutaneous Insulins: Meta-analysis of Clamp Data from Three Clinical Studies 975-P / 975 - A Population PK/PD Model of Technosphere® Insulin Administered to Healthy Subjects
100-LB / 100 - Technosphere Insulin Inhalation Powder (TI) Displays Earlier Onset and Shorter Duration than Insulin Lispro (Lispro) <--- [Late Breaking]
102-LB / 102 - Within-Subject Variability of Insulin Exposure and Metabolic Activity following Replicate Doses of Technosphere® Insulin Inhalation Powder (TI) in Patients with T1DM <--- [Late Breaking]
information on euglycaemic clamp technique illingworthresearch.com/2012/07/20/glucose-clamping-in-clinical-trials/
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Post by kc on May 16, 2016 16:44:39 GMT -5
just curious if anybody has been paying attention to the most recent Toujeo TV commercials? Does it seem like they have changed their warnings and contradictions on how to use it? Perhaps they language has always been there but it seems to me that they have changed the warning about not using Toujeo with other insulins. The don't specifically mention Meal time insulin but it seems like they have changed their warning? Am I imagining this or did they change it recently (after their April give back to MannKind of Afrezza rights). Perhaps this has always been the same message. I looked on the Toujeo web site and the language might really mean not to mix different injected insulins? take a look and then watch the commercial the next time it runs. I saw about 3 of them over the weekend.
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Post by hopetoretire on May 16, 2016 17:30:31 GMT -5
just curious if anybody has been paying attention to the most recent Toujeo TV commercials? Does it seem like they have changed their warnings and contradictions on how to use it? Perhaps they language has always been there but it seems to me that they have changed the warning about not using Toujeo with other insulins.
KC, Actually, the warning to not use Toujeo with any other insulins was my first early-warning alert that they were going to dump Afrezza. Wish I would have sold on the first such commercial and bought back in later.....is it later yet? The warning has always been there and was like a punch to the gut when I first saw it. Every Toujeo commercial (and there are a lot of them), makes me angry. Hoping the new MNKD team can get some traction and get our superior treatment moving. (in since IPO and that's a long long time on this road)
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Post by peppy on May 16, 2016 17:39:57 GMT -5
just curious if anybody has been paying attention to the most recent Toujeo TV commercials? Does it seem like they have changed their warnings and contradictions on how to use it? Perhaps they language has always been there but it seems to me that they have changed the warning about not using Toujeo with other insulins.
KC, Actually, the warning to not use Toujeo with any other insulins was my first early-warning alert that they were going to dump Afrezza. Wish I would have sold on the first such commercial and bought back in later.....is it later yet? The warning has always been there and was like a punch to the gut when I first saw it. Every Toujeo commercial (and there are a lot of them), makes me angry. Hoping the new MNKD team can get some traction and get our superior treatment moving. (in since IPO and that's a long long time on this road) This is news to me. How would it be a type 1 using long acting Toujeo ; www.toujeo.com/ A concentrated lantus as far as I can tell. slow release, ph. wouldn't need a short acting meal time insulin? Afrezza, or Rapid-acting Humalog Novolog Apidra 10 - 30 minutes ? Dumb this down for me, please. Pep
Added; oh, did you mean type 2? yeah the guidelines need to be changed now that there is a rapid acting insulin that does not cause hypoglycemia. I wonder if the clamp study results being made public will help Afrezza there.
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