Spur Therapeutics Announces Successful End-of-Phase 2 Meeting with FDA for FLT201, Its Gene Therapy Candidate for Gaucher Disease
FDA aligned on single-arm Phase 3 study to support potential accelerated and full approvalOn track to dose first patient in Phase 3 trial in ...
precisionmedicineonline3d
Spur Therapeutics, FDA Align on Phase III Plans for Gaucher Disease Gene Therapy
The FDA has offered positive feedback on possible paths forward for accelerated or traditional approval of FLT201 using data from a single-arm study.
Spur Therapeutics Announces Platform and Poster Presentations Highlighting New Clinical Data for FLT201 in Gaucher Disease at Upcoming WORLDSymposium
Additional details on the meeting can be found at the WORLD Symposium website. About Spur Therapeutics Spur Therapeutics is a clinical-stage biotechnology company focused on developing life-changing ...
Yahoo Finance4d
Spur Therapeutics Announces Successful End-of-Phase 2 Meeting with FDA for FLT201, Its Gene Therapy Candidate for Gaucher Disease
“We are very pleased with the outcome of our end-of-Phase 2 discussion with the FDA ... will be a single-arm study in adults with Gaucher disease type 1, similar in design to GALILEO-1.