Tuesday, December 18, 2018 11:46:46 AM
Meaning.
1. We have a more or less set date for the final full data completion for all patients 12 month Bridge by January 2020.
2. There are only 3 more patients to recruit for Bright (so hopefully we will see some interim data on that soon, as many of these will have completed their first 6 months, similar to the interim Bridge study we saw).
3. 23 patients left for the Balance Trial.
4. With enrollment of one of the trials done, should mean faster enrollment for the remaining studies.
Also great to hear that they have move up the timetable for Accelerated Approval discussions with the FDA. In the last call they mentioned in 1H 2019, now they are stating 1Q 2019.
Again based on the latest FDA guidance, it would seem 102 meets the criteria for Accelerated Approval in such conditions as Fabry.
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