Trials start when the first patient is enrolled and dosed and end with the last patient last visit (or last data entry, I forget which). So a 7 week study is not happening in a seven week period . . . it drags out with enrollment growing to the full complement, or a bit higher. That can and does take a long time.
Recruitment for the 36 patients took about a year --- September 2021 is the date when the 7 week controlled study finished - Last patient last visit. The one year OLE ends in 2H2022.
The TLD will be for the 7 week study. At some point in the future, OLE data may be reported. If the drug is approved in the future for Rett, OLE safety data will be part of the label but OLE efficacy data will not.
The "Phase 3" is 7 weeks and is the data we are expecting year-end. OLE data is separate and typically done for 3 reasons: 1. improves recruitment (parents more likely to let their kid go through if they eventually get the tested drug) 2. gathers longer term safety data for rare events (though rare events still unlikely in a small study). Regulatory agencies are interested in this result. 3. gathers limited efficacy data - is any effect maintained longer term? Do switchers do well? Regulatory agencies are less interested in this result as it is uncontrolled and may be in a smaller non-random cohort due to drop outs.
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