Wednesday, August 24, 2016 7:19:18 AM
based on two previous Rett Syndrome Orphan Drug developments, it looks like the process will take longer.
Orpahn Drug waas granted to Neuren in May of 2015..
Neuren began enrollmwnt of Phase 2(safety)about 1 year later..
I think they are currently enrolling for Phase 3 ..11 Week Trial..
Topline results next year..
So 2 Years from ODD..
2 Trials run and completed..
May of 2016..
We would be looking at 2018 for Topline results..
The time between Desgnation and Trial Design for Rett Syndrom
appears to be 3 Montrhs for NEWRON and 6 months for NERUEN..
SO..the GOOD NEWS is..
Sometime between now and Novemeber..We should hear some
POSITIVE RETT Syndrome Announcement!..
N
eworn Received Orphand Drug Designation in July of 2015,
Approval to Test in April of 2016
and Trial Enrollment . July of 2016..
Newron received Orpahn Drug Status in July of 2015 and
3 Months later Announced Pivotal Trial..
MAY, JUNE , JULY/August
So, the good News, probably within 2 months we will get TRIAL DESIGN..
Let the excitement begin!
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