To be honest, today's announcement doesn't sound negative to me. Did Dr. Gittleson feel upset about the feedback from FDA? I guess not.
"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."
That's the process.....SO, don't get distract from this announcement....
Remember, the company main priority is always focused on EMA (Europe) ... FDA is a bonus!!
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- Ann: ANP Updates on US Regulatory Plans for ATL1102 in DMD
To be honest, today's announcement doesn't sound negative to me....
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