Complete longitudinal data for the 12-week time point of PART B will be provided once this data becomes available. This is not yet available to the company. As stated in the third bullet point on slide 26 of the AAT presentation, please be assured that it will be issued once available, however we are unable to provide guidance on the timeline. The details relating to pharmacokinetics and pharmacodynamics are being fully analyzed so that there can be no doubt as to the cause-effect relationship of the 12-week efficacy data and this must be completed before it can be released.
The company is excited about the data received to date and by the request for an additional two-year extension from patients and caregivers, as announced in a press release March 10, 2016.
Please do not hesitate to contact our office if we can be of further assistance.