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Post by mango on Aug 25, 2017 12:40:20 GMT -5
Yep, when soldering doesn't work, welding is the sure fix (:> Ah, spelling mistake. I meant wield. Mango wielded a shotgun. it happens...
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Post by dreamboatcruise on Aug 25, 2017 14:10:03 GMT -5
Makes absolutely no sense to me. Several have pointed out that the "Estimated Study Completion Date: January 2021" for what should be an easy phase 1 study seems pretty bizarre. Most of the secondary measures involving PK/PD take only one day. Then the primary outcome measures take only 6 weeks: "•Number of patients with adverse events [ Time Frame: Baseline to week 6 ] •Number of patients with hypoglycemic events" The one requiring so much time is "Measurement of anti-insulin antibodies" which takes "up to 13 months." Was this Mannkind's or the FDA's idea? Nowhere have I seen much interest in anti-insulin antibodies in either kids or adults. Why include it, especially since it is what takes so long? But if they insist on doing a trial that's going to take years to complete, where is A1c? That's the only thing that matters to insurers. On top of all that, they have no RAA arm to compare to, so even if they get good numbers, they still won't be able to claim superiority to lispro. I don't think anyway around doing the immunological stuff. This actually has been an area of interest for the medical community since the very early work in inhaled insulin because of valid concern about the fact that the lungs are very immunoreactive... it's an area where the body is on high alert to identify things that need to be eradicated. Granted few people here know about this... had one of the usual suspects claim I was making it up when I recently posted that there was such a thing as anti-insulin antibodies and that it was something looked at in the Afrezza trials. Kids immune systems are not the same as adults, so I would think it almost guaranteed this would be something FDA would insist on. This is safety trial not efficacy. It's just the way trials are done in steps. That happens for all drugs. They want to test safety on a smaller set of patients which would be too small for the desired "statistical power" needed for the efficacy tests.
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Post by cretin11 on Aug 25, 2017 15:03:43 GMT -5
Yep, when soldering doesn't work, welding is the sure fix (:> Ah, spelling mistake. I meant wield. Mango wielded a shotgun. it happens... Learning how to use a shotgun at age ten is to be expected for kids growing up in the country. But welding at age ten? That would be impressive!
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Post by madog365 on Oct 19, 2017 11:28:11 GMT -5
Updated last week - Actual Study Start Date: September 28, 2017
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