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art2426

11/07/15 5:50 PM

#61674 RE: RVC #61658

IMO we won't hear anything about the 501K from the company until first announced by the FDA. Then you will hear the response from BIEL on the FDA's action. I have been around for years and recall from the past that The FDA was not pleased with comments made by our fearless leader on impending status of filings. This is what bothered me with his comment on seeing some action before year end. Smart to keep quiet and let the FDA, which works at its own pace, do its thing. They don't like to be told WHEN their response is expected. I hope that the company has learned their lesson in this matter and I believe they have, as I have seen changes in management actions to legitimize the credibility of this company. Example: previously (couple years ago) they would send out PR"s for every little company occurrence. Cheapened the image of the company considerably. No legitimate company PR's the licking of a stamp (alright - over dramatized). They seem to be learning on the fly about proper publicly traded company protocol . Anyway that is all in the past and IMO the reason for this extreme long time frame to FDA OK. But NOW with lessons learned, it seems to me that they are on the right track to the most coveted goal of the company: FDA OK and seeing their products on the shelves in our retail outlets in OUR country.