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Re: ghost42 post# 21042

Friday, 04/20/2012 11:06:06 AM

Friday, April 20, 2012 11:06:06 AM

Post# of 330435
Just catching up here Casper but I agree with what you say. I would never ask a CEO to predict when he thought he was going to get FDA approval on a product, under the assumption that he would look at me as if I'd just asked the most stupid question on earth.

The most truthful answer could only be, "I have no idea you moron; when I know, you'll know." Anything else would be pure speculation, with a conflicted tinge or blatant dose of hope - ergo - I'm hoping soon! So why ask the question at all?
clearly
But if we turn it around, is this not a classic case of 'no news is good news'? Would BIEL not have regulatory obligations to release news of any adverse rulings or rejections by the FDA? If so, I venture to say that since we've heard nothing, therefor we're alive and well at the FDA and in-process. And the CEO saying "soon" regarding approval on 8 products means, to any reasonable person, that he has not received rejection notices from the FDA, or whatever they do in such cases. Seems to me this guy is still in the game fighting for approvals.

Just another thought. I'm not an FDA type guy, maybe you, ImRich or Fuente can answer this, but could the FDA rule that it won't give BIEL the applied for OTC clearance for the 8 products but it will give this or that type of more limited approval instead? And if so, would that not also be great for the company? Perhaps not as good as OTC approval, but still great? I would see that as a triple versus a home run. And would FDA give such limited approval, like Rx, when the rest of the world has given OTC clearance, like civilized and conservative Canada to the north?