A re-do? That is not what happened. The notion that BIEL, and only BIEL, was responsible for changing the classification of an entire product class is incorrect. Their products were rejected not based on their product class, but based on the fact that they did not work, according to the FDA.
No where in the rejection letters does it state that BIEL would have been cleared except there wasn't a code to clear them in to.
There was no re-do.
And with statements from Andy that FDA has not asked for additional information, that number shrinks to basically zero.
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