InvestorsHub Logo
icon url

DewmBoom

11/10/18 2:54 AM

#157981 RE: jaysolano #157979

The management in their reply, they did not invent the wheel. They simply stated the FDA guideline of FDA for traditional 510K. Now what I am talking about follows the FDA guidelines. Either Biel will get approval or they will get a letter from FDA on why it has been delayed.

Thus, under any circumstances, shareholders should hear from BIEL on the FDA status if they want to be transparent with shareholders.

Hopefully, we get the clearance and move to the next step.
icon url

GetSeriousOK

11/10/18 9:16 AM

#157994 RE: jaysolano #157979

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.