“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 prog
ram as well as clear the path for FDA consideration of the FTD submission.’
The above was written by the CHAIR .. CG.
Would she write that if it wasn’t true ?..CG said in a webinar that she believes in working with the FDA at close quarters to get a drug to market for Rare Diseases where there is a huge Unmet need
...
Sure there are sellers but there are also buyers...
Nothing has changed... Primary aim for Anp was the EAP... however there was a great deal of interest from the US that Anp decided to make a positive move..
Once we get the lifting of the partial hold at 25 mg per week the IND becomes active and Fast track will follow..
So don’t panic!! Don’t listen to long term holders who are frustrated .. It’s a waiting game with HUGE rewards $$$
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- Ann: ANP Updates on US Regulatory Plans for ATL1102 in DMD
Ann: ANP Updates on US Regulatory Plans for ATL1102 in DMD, page-107
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