”More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval.
lMore frequent written communication from FDA about such things as the design of the proposed clinical trials and use biomarkers
o markers.”
:https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track
Akki :
once again you post with a hidden agenda…
Remember EAP was the Primary objective.
So much interest in US.. was compelling that Anp decided to move ahead…..
Ann: ANP Updates on US Regulatory Plans for ATL1102 in DMD, page-143
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