Fast Track designation after the partial hold issues are resolved.’
Antisense Therapeutics Ltd Chair Dr Charmaine Gittleson said, ‘We are pleased the FDA shares our view that DMD is a serious condition for which ATL1102 may have benefit and that FDA is working with us in navigating through the technical regulatory requirements.
A lifting of the partial hold would facilitate the IND becoming active and potentially allow for patients in the USA access to ATL1102 through a clinical program as well as clear the path for FDA consideration of the FTD submission.’
Wow ! Does this mean Patients with DMD can access atl1102 ....Through a clinical programme...in the USA..?
Ann: ANP Updates on US Regulatory Plans for ATL1102 in DMD, page-8
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