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Additional thoughtsI don't recall Obrien discussing the video based scoring on the call yesterday. And I don't know if a centralized expert rater was used or an onsite rater. However, one can imagine a similar path being pursued in TS as TD. Show the FDA that centralized video rating is superior to the other potential primary endpt instruments and then make it the primary endpt for the kid p3. This would likely occur with the FDA at the end of phase 2 meeting for TS in kids. Mere speculation at this time. Crab |
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Msg # | Subject | Author | Recs | Date Posted |
41845 | Re: Additional thoughts | ashtonb22 | 3 | 1/18/2017 3:02:25 PM |