This face to face meeting was attended in person by the company (Dr Itescu and others) and Dr. Nicole Verdun – being the newly appointed permanent Director of the FDA’s Centre for Biologics Evaluation and Research Office Of Therapeutic Products. The presence of senior leadership from the FDA is an encouraging sign of the intent of the Agency to facilitate an approval for Remestemcel-L
Also the Center of Blood and Bone trial network were present.
In my opinion the Trial network attended the meeting to ask the FDA why this therapy has not been approved . They have used it and believe it to be effective.
Approval late March is a distinct possibility and so it should be if the Assay Data is suitable.
30c straight to $2.00.
Aloha.
banter and General Discussion, page-8241
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