Guys,
Can we stick to the subject on this thread please? This thread is for where we are at with the FDA:
This the last up to date one I collated:
https://hotcopper.com.au/threads/regulatory-pathways-where-we-stand-with-the-fda.6185094/page-45?post_id=55361579
Essentially:
C-19 ARDS: minutes any time soon on registration pathway for Remestemcel-L
GVHD: Following discussions with the FDA’s (CBER) talking to the Office of Tissue and Advanced Therapies (OTAT) to address potency assays etc with a view to a resubmission of the current Biologic License Application
CLBP: Requested a Type C meeting with FDA to discuss approval
CHF: Requested meetings with the FDA on application pathways
Guys, Can we stick to the subject on this thread please? This...
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