In my personal opinion, the main question from FDA points more to lack of capability then expertise, lack of talent and qualification then comprehension. I have recommended a face-to-face discussion.
What Dr Fisher has stating is FDA at the time was under qualified and unfamiliar to Radiogel to recommend any human study's.
Dr Fisher was granted his face to face discussion with FDA heads, and was asked for ONLY animal study's at this time.
Get your facts up to date. Last years news is so last year.
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