There are way too many opportunities for the FDA to block drugs and devices such as BIEL is offering that are not related to performance issues. Arbitrary blocks disguised or rationalized by some lofty reason occur.
The US is too regulated. Then those regulations begin to have conflicting results. Test products to infinity but keep the costs down. Doesn't make sense to me.
On the other hand, I don't see the US market as a savior for BIEL. Sales in other countries has not materialized and grown as one would have expected. To reiterate what the company has said before, the US was to be only about 25% of their business.
Dilution has always been a concern in my mind. That has been compounded by the SEC action.
Another thing that has occurred is the rolling advocate/employee list over the years. There has been no cohesive plan.