CEO's always say Safe Harbor nonsense like "3 months." notice it's always preceded by "we expect" or "we believe."
The FDA RARELY clears a 510(k) in 3 months. Plus, the FDA came back with questions, as they almost ALWAYS do... Plus, there's a nasty history between Andy and the FDA... plus, the holiday season approaches.
The FDA is not going to move faster with BIEL than they do with every other company that submits a 510(k). Add those "pluses" above... Holding one's breath waiting for FDA clearance is folly.
As for BIEL buying its own stock... the Whelans don't buy and hold their stock. They convert debt and SELL their stock. that's not going to change for a long time, if ever.