Thursday, September 29, 2022 1:01:45 AM
"the regulators have not agreed to remove the partial hold, but have allowed all of the patients in the Trial to continue being treated in accordance with the Protocol. The Company is pursuing ongoing dialog with regulators. However, at this point the Company believes that the potential benefits that could be obtained from enrolling the final 17 patients would not be worth the time it would take, as the process of re-starting and re-training the sites (including through Institutional Review Board renewals) for further enrollment would take months, followed by further months for the recruitment itself.
Accordingly, the Company is no longer seeking to enroll the last 17 of the 348 patients. Rather, the Company is focused on accumulation of the “events” necessary for the Trial endpoints. When sufficient “events” have accumulated, the external parties managing the Trial will then begin the process of moving toward “data lock” and then analysis of the data, which are typically each multi-month processes, particularly for large international trials."
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