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Re: av8tor65 post# 162748

Saturday, 12/01/2018 12:09:27 PM

Saturday, December 01, 2018 12:09:27 PM

Post# of 330183
We should NEVER EVER attempt a 510(K) without the dream team present, helping us thru. Most of us dont have a clue of the ways the FDA will be able to continue punishing BIEL as they are really just protecting big pharma. And dont forget, as we're in the middle of an Opioid Epidemic, the FDA approved another Opioid, this one is now 200 TIMES more powerful than the previous most powerful Opioid. (SLAP)

I think if the FDA didn't bring it up (women / men efficacy) during the 510(K) meeting May 9, if the GP gang was part of this process, and they brought up the point that it works better on women vs men, then they would have an opportunity to earn their money. They would have SCHOOLED THE FDA with that BS arguement. They may have even had a better writt. Explanation in the 510(K)

The Dream team was left out to SAVE MONEY. Now looking back in hine site, the SEC money was greatly reduced from its original. If they didnt have to play CHEAP and Goodwin Procter was at the table during this most recent process, we'd have full FDA Clearance.

If we continue this process without GP, expect more of the same, because the FDA makes up rules as they go along.

Now Bayer is selling off Coppertone and Dr Scholls, after peeping thru our books for the past year. Again IMO, we had no idea this could possibly turn out so HORRIBLY BAD.

I admire his persistence and never give up mentality, but a serious change in direction needs to happen here, our just watch our money BURN.

SHAREHOLDERS NEED TO VOICE THEIR PERSONAL CONCERN NOW, if they have any concern at all at this point.

Looking back, isnt it STRANGE that KN used the word IMMINENT to describe the Dr. Scholls deal.

That was the exciting part for me, after getting others to notice this product after the NHS legitimized it, and FDA wanting meetings after the cost benefit analysis was released.

Something just isnt adding up? I am very concerned about this entire next move. Its critical to our existence.

My comments above are simply my opinion and nothing more.
I'm enthusiastic at times however I am NOT a professional trader.
Please contact a financial consultant for investment advice.