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Sunday, 06/02/2019 10:27:20 AM

Sunday, June 02, 2019 10:27:20 AM

Post# of 21574
I took another look at the PR's and the clinicaltrials.gov site to try to estimate the end of study and likely date of topline data release. I know others have done these calculations but I wanted to do for myself.

Interestingly, the clinicaltrials listing was updated last week and the link compares the last two entries. The update still says 7/30/19 for anticipated study completion. Outcomes were clarified in last weeks update.

Patients receive the 7 doses of drug on day 0, 7, 21, 35, 49, 63 and 77.

The PR of the last patient dosed was 830 am on 3/13/2019. I double checked the PR and it clearly says dosed, not just enrolled. So, lets assume the last patient dosed was 3/12/2019. The last patient last dose, 77 days later, occurred last week (5/28/19) but doses could have a +/- 2-3 days (most studies have windows to allow efficient scheduling though this level of protocol specificity will not be on clinicaltrials).

Patients are observed for 30 more days as part of the protocol, so the study should be complete 6/27/19 +/- 1-3 days. Study completion should get a PR the next day so we should know for certain by 6/28/19 or 7/1/2019 at the latest. Topline release should be 6-10 weeks later, 8/8/19 to 9/5/19.
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