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Repost of Trial Timeline Expectations - Note Schizo trialsUpdated for MDD Trial Timeline Expectations - UpdatedNow that we know enrollment completed in April for the 2 Schizo trials, we can update the timelines to be more specific for those 2: PhIII Schizo inadequate response: - Enrollment Complete Apr 2019 - Efficacy topline mid-June 2019 (6 week protocol) - AE topline mid-July 2019 (clinicaltrials.gov shows 1 month between efficacy and AE readouts) - Announcement could be anytime mid-July onward - Note: ACAD stmt is 'mid-2019' PhIII DRP: - Topline Mar 2020 (clinicaltrials.gov) - Interim readout 2H 2019 (ACAD stmt); my calcs are anytime from June onward Note: ACAD stmts have been 'most trials using this trial design complete successfully at the interim' PhII Schizo negative symptoms - Enrollment Complete Apr 2019 (last week of Apr is week 18 of 2019) - Efficacy topline end-Oct 2019 (26 week protocol: last week of Oct is week 44 of 2019) - AE topline end-Nov 2019 (1 month after efficacy readout on clinicaltrials.gov) - Announcement Dec 2019; ACAD stmt is now 'year-end 2019' PhIII MDD (2 trials) - Initiation 2019 for both (ACAD stmt) - US trial initiated Apr 2019 - US topline expected June 2021 PhIII Rett for Trofinitide - Initiation 2019 (ACAD stmt) |
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Msg # | Subject | Author | Recs | Date Posted |
15323 | Re: Repost of Trial Timeline Expectations - Note Schizo trials | Paul777333 | 4 | 7/2/2019 1:14:03 PM |
15803 | Timeline Expectations - Updated 2019 Oct 21 | longusa | 25 | 10/21/2019 2:49:04 PM |