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
I think they are going for home base without selling the farm.
Its now up to Jane Bell it seems.
Aloha.
Cell Therapy News/Articles, page-16994
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