This product has been granted a "priority review" by the FDA, which means that there is no other product on the market that meets this medical need.
The data is VERY solid. For those of you that buy stock, the FDA review (and almost certain approval) will probably conclude in mid-December.
My old boss and friend is the project leader on this product. Hoo boy, does she have good quality "anecdotes" from the clinicals.
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