I received an answer from the company today regarding the timing question asked above. To paraphrase, and consistent with their messaging to date, expectations are that recruitment completes in the coming weeks. Patients then enter the background medication stabilisation period – which can be up to 6 weeks (this timing is dependent on what background medications the patient is on and how long they have been on them prior to the trial, some may only need a couple of weeks and others the full 6 weeks). As such, the final date of data outcome is driven by the last patient being dosed (currently expected sometime between mid-November and mid-December), which means the 1st interim 35 week endpoint could be between July and August based on current recruitment rates – with date reported a couple of weeks later. As is always the case in clinical trials, timing is always subject to recruitment and thus they cannot be absolute until all patients have been dosed.
I hope that helps.
GLA
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