Wednesday, March 05, 2014 12:59:56 PM
At the time of the application in 2009 I suggest BIEL management was flying on a wing and a prayer without knowing the science and processes necessary to obtain FDA approval. I have faith now that the scientists on board now will pilot the next application more professionally with the desired results.
With respect to my use of the word 'slide' I was implying that the creation of the new category by the FDA allows BIEL to slide into an apt it BIEL would remain without a category to apply under.
I think we are on the same page.
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