Incorrect fuente, Andy did not say FDA told him anything. I know that Andy was speculating, when asked by a shareholder around Nov 1, that he felt Dec 15 might be a date, nothing more, nothing less.
You're correct, FDA would never say something like that, they did not, and Andy did not say they did.
Again, I totally disagree with you. State the Regulation that requires FDA to perform this review in 100 days.
The only regulation that covers a required 510K is 21CFR807.
I suggest that you contact FDA to verify your reg requirement and share with the BIEL BOARD.
BIEL is a global business which require a great deal of finances to cover their expenses in production, manufacturing, and distributing their products. There financial plan is excellent to bring these products to market with minimum expenditures.
STAYING THE COURSE! WILL BUY MORE SHARES TOMORROW.
I AM A MAJOR LONG TERM BIEL INVESTOR WHO BELIEVE IN THE MISSION OF BIOELECTRONICS.
Another stock I was in (getting back in soon) for a year that's very similar to BIEL technology (non P.E.M.F. though) keeps making money for shareholders year over year (no r/s at all) hitting it out of the park again and again..with non-existant sales, poor company structure..while they shell out big money for F.D.A. that never happens. BIEL has big sales, selling in multiple countries, is a well known product in the U.S., has years of commercial clout and growing established customer base (everything the other stock I had didn't have) There's no reason why this can't even be at 0.01¢ - 0.03¢ right now. January revenues should push the PPS up to 0.005 minimum.
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