Hey Josh - I think we'll possibly see 4 price moves:
First, when the FDA request for comments to its proposal to create a new class of devices, which BIEL could be in, if approved, i.e. Class II and approved for OTC sales in the US expires May 21;
Second, when FDA publishes that it has created the new Classification it's proposing;
Third, when BIEL files a new 510K application for consideration for the new classification; and
Fourth, if, as and when FDA approves the BIEL application. BIEL says it has it's application requirements in good shape, trial data, etc.
Do some DD, check out FDA publications, they are pretty positive.
What the price moves might be, would be foolish speculation, what the price fall-offs might be during waiting periods. Just as foolish.