Do correct me.. this is off the top of my head..
so the Turkish boy who's been dosed first will finish his 6 months blinded dosing by start December '23. (At this time, the last patient will have been dosed.) Boy 1's results will be locked until the last boy finishes his 6 months.
In December this year he, boy 1, will continue straight into open label dosing, with a result readout after 4 months.
that 4 month readout will be in April '24.
May, June passes = a full 12 months of dosing finished.
Boys dosed in July and August will have their 4 month o/l readout also available by July.
July, the 6 month double blind results are released after analysis, and we go to FDA and EMA....
Can we include the o/l results so far as well in our data package? If so, I imagine this could include an additional 6 months of data for boys dosed this month, plus, data from those that started July and August providing additional 4 month data.
is this possible?
tox study data
6 month double blind data
12 month data for eg 5 boys from Turkey
10 month data for eg 5 boys from Turkey and Bulgaria
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