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Pediatric
Apr 30, 2019 20:30:59 GMT -5
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Post by fldave007 on Apr 30, 2019 20:30:59 GMT -5
Where is Mnkd on pediatric trials? Any news coming out?
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Deleted
Deleted Member
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Post by Deleted on May 3, 2019 10:12:44 GMT -5
Where is Mnkd on pediatric trials? Any news coming out? Finishing up Cohort #2. Currently recruiting for Cohort #3 which should start in June for 6 months. Expecting Phase 3 to start by year end (which means 1Q20). Not sure how long the Phase 3 will take.
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Post by peppy on May 3, 2019 10:54:59 GMT -5
Where is Mnkd on pediatric trials? Any news coming out? Finishing up Cohort #2. Currently recruiting for Cohort #3 which should start in June for 6 months. Expecting Phase 3 to start by year end (which means 1Q20). Not sure how long the Phase 3 will take. clinicaltrials.gov/ct2/show/record/NCT02527265Just because I found it when looking:
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Post by lojothehus on May 3, 2019 11:22:36 GMT -5
Yes, I would like to hear more about that.
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Post by #NoMoreNeedles on May 3, 2019 11:35:13 GMT -5
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Post by agedhippie on May 3, 2019 11:38:16 GMT -5
Finishing up Cohort #2. Currently recruiting for Cohort #3 which should start in June for 6 months. Expecting Phase 3 to start by year end (which means 1Q20). Not sure how long the Phase 3 will take. clinicaltrials.gov/ct2/show/record/NCT02527265Thanks for the link Estimated study completion January 2021. At a wild guess I would say if they filed the label change promptly then some time in 2021Q2 for the label to be approved.
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johny
Researcher
Posts: 87
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Post by johny on May 4, 2019 19:25:15 GMT -5
I don't know how pediatric drugs are classified, but if they include an age range, I wouldn't be surprised to see children as young as 4 using Afrezza. Objective: AFREZZA™ [insulin human (rDNA origin)] is delivered to the lung with a proprietary delivery system (Gen2), which is an easy-to-use, breath-powered, high-resistance inhaler with single-use, unitdose cartridges. Methods: In total, 74 subjects were divided into five age groups: 4–5 years (n = 14), 6–8 years (n = 15), 9–10 years (n = 15), 11–13 years (n = 15), and 14–17 years (n = 15). Subjects were given a brief introduction to the system and then shown a sequence of pictures and scripted verbal instruction to demonstrate system assembly and operation. Inhalation profiles were measured using the BLUHALE™ inspiratory system. Results: All handling, assembly, and operation steps with the Gen2 inhaler were performed correctly by pediatric subjects 6 to 17 years of age. In the youngest population group, 92.9% of subjects were able to perform all steps correctly, with only 1 subject observed having difficulty with one step. All subjects in all age groups were able to demonstrate inhalations that exceeded the minimum required for acceptable device performance Conclusion: Pediatric subjects as young as 4 years of age can successfully handle, assemble, and operate the Gen2 delivery system. journals.sagepub.com/doi/pdf/10.1177/193229681100500240
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