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Post by parrerob on Apr 19, 2021 7:14:37 GMT -5
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Post by uvula on Apr 19, 2021 7:24:23 GMT -5
15. Exposure to Afrezza in the 30 days before screening
I wonder why current Afrezza users are excluded from the clinical trial. I would think they would be the best candidates for a dosing study. It isn't a study to see if afrezza works. It is a study to see which dosing method works best.
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Post by dh4mizzou on Apr 19, 2021 7:25:07 GMT -5
Interesting. Wonder how much input they got from VDEX. And it's nice that the study is scheduled to be completed in September of this year.
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Post by longliner on Apr 19, 2021 8:06:53 GMT -5
Interesting. Wonder how much input they got from VDEX. And it's nice that the study is scheduled to be completed in September of this year. I wonder how much input they got from Sanofi? |
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Post by sellhighdrinklow on Apr 19, 2021 8:28:58 GMT -5
Enrollment is only 20 patients.
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Post by uvula on Apr 19, 2021 8:32:29 GMT -5
Enrollment is only 20 patients. So we might end up with 20 new afrezza users! |
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Post by oldfishtowner on Apr 19, 2021 8:36:21 GMT -5
Looking forward to the label change.
While many may be more excited by the Tyvaso DPI NDA submission, this dosing trial may prove to have more impact on Afrezza sales and MNKD's stock price in 2022 and in the long run, if not this year. Between MNKD's participation in the Medicare Part D Senior Savings Model, the pediatric study and this dosing study, 2022 may prove to be a watershed year for Afrezza and for MNKD. |
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Post by uvula on Apr 19, 2021 8:46:11 GMT -5
Label change? This clinical trial will do nothing to change the non-inferior label.
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Post by celo on Apr 19, 2021 8:54:29 GMT -5
Sorry for my ignorance, mannkind should know by the huge amount of personal patient responses to date what works best for their consumers. What does the dosing study do for the label? The prescribing endo doctors? Does this allow endo to use concrete evidence when prescribing? It would seem, especially with afrezza, reactions to uptake is based a lot on the individual. Their weight, fitness, lung capacity...I mean the list of variables are endless from patient to patient.
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Post by mango on Apr 19, 2021 11:59:50 GMT -5
MKC-TI-191 is a Phase 4, single-arm, multicenter, proof-of-concept clinical trial evaluating the efficacy and safety of Afrezza, administered according to the current Afrezza prescribing information (PI) compared to a titrated dose, in combination with a basal insulin in adult subjects (≥18 years of age) with type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM).
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This is a POC Phase 4 clinical trial. Completely normal for there to be a very small participant pool.
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Post by porkini on Apr 19, 2021 12:14:21 GMT -5
MKC-TI-191 is a Phase 4, single-arm, multicenter, proof-of-concept clinical trial evaluating the efficacy and safety of Afrezza, administered according to the current Afrezza prescribing information (PI) compared to a titrated dose, in combination with a basal insulin in adult subjects (≥18 years of age) with type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM). —————————————— This is a POC Phase 4 clinical trial. Completely normal for there to a very small participant pool. Highlighting added, thanks mango! |
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