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Post by mnholdem on Dec 11, 2015 7:45:20 GMT -5
Estimated Enrollment: 46 Study Start Date: August 2015 Estimated Study Completion Date: July 2017Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure) Hmm, is there a pediatric T2DM study as well? Edit - doh! this is only a Phase 1 study
Some thoughts on the pediatric study. Although the study completion date is give as August 2017, the protocol is only 6-8 weeks in duration. With only 46 patients, there is a good possibility that enrollment could be completed quickly. If so, it seems that data collection for the primary outcomes and all but one of the secondary outcomes could be completed by February or March? What I am thinking is that basically the trial results will be available for Sanofi to present to the FDA well before the August 2017 completion date.
The FDA wants a 2-part pediatric trial, with the Part 1 for type 1 diabetes and Part 2 for types 1 or 2. Part 2 of the trial includes a 52-week randomized intervention phase.
Here is the FDA description of the post-market requirement:
An open-label pharmacokinetic (PK), and multiple-dose safety and tolerability dose-titration trial of Afrezza in pediatric patients ages 4 to 17 years (inclusive) with type 1 diabetes (Part 1), followed by a prospective, multicenter, open-label, randomized, controlled trial comparing the efficacy and safety of prandial Afrezza to prandial subcutaneous insulin aspart used in combination with subcutaneous basal insulin in pediatric patients 4 to 17 years old (inclusive) with type 1 or type 2 diabetes (Part 2). Part 2 of the trial should include a 4-week run-in phase and a 52-week randomized intervention phase.
Sanofi has not published nor have they begun recruitment of a trial that studies the FDA requirements for Part 2 studies, but it looks to me that in order to meet your estimate of completing the pediatric trial(s) by August 2017, they would have to recruit and start the Part 2 pediatric trial by May/June 2016 at the latest.
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Post by kball on Dec 11, 2015 7:58:11 GMT -5
Can the math whiz's here take a stab at earliest possible pediatric approval?
The more i think about this the more i think penetration stages are likely to be 1. Type 1 w CGM 2. Pediatric patients 3. Some adult T2's (maybe 2-5 years out)
edit: U.S. market
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