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Post by jjacobs122 on Aug 16, 2019 7:55:53 GMT -5
Anyone know the Best Case Estimated Date For Pediatric Approval?
Thank you
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Post by peppy on Aug 16, 2019 8:09:21 GMT -5
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Post by mnholdem on Aug 16, 2019 11:55:29 GMT -5
Much will depend upon how long it takes to work out the Phase 3 trial design with the FDA. I've seen that process take 6-9 months with other fairly straightforward drug candidates. With the Phase 2 trial, MannKind did not run the three cohorts simultaneously. It's hard to day whether they will with the Phase 3 trials. All I know with any certainty is that the trial design will be crucial. Any failure to hit primary endpoints would be a disaster. Also, I'm not entirely certain how much control/influence MannKind will have on the clinics participating in Phase 3. We read a post several months ago concerning a Phase 2 site clinician/nurse who dosed her patient 15 minutes before taking him/her to lunch across the street. Lack of discipline related to the timing of doses will negatively impact the outcomes. That's what happened with a few of the major pre-approval trials that MannKind conducted. The instructions need to be crystal clear and adhere to. I certainly hope that the clinics are required to record the minutes between dosing and eating.
Back to the initial question: I think ped approval (if primary outcomes are met) could be as long as 2021-2022.
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