Simpsonly Thursday, 10/06/16 05:49:15 PM
Re: fuente post# 85695
Post # of 85729
No, wait just a minute - you have stated several times the BIEL 510(K) is dead - that is a statement of fact.
Again, my previous post about that:
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Just a few snippets from recent days . . . . .
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* At this point I am skeptical that any meetings have taken place outside of the initial rejection of the 510k.
* Their 510K is dead anyway. They just aren't telling you.
* Believing good news on the 510k is coming When it's clearly dead.
* Praising Andy when he's nothing but a two bit crook.
* If meetings are ongoing, why would anyone think it's a positive? BIEL has requested these meetings in the past to basically beg for clearance - even Hong as far a getting a congressman involved. Turned out it was a giant failure.
* This is probably what they are doing right now.
* The next piece of news regarding FDA will be the pumping of the de novo app that they will somehow spin as a positive a and of course some will buy into that.
* The 510k is dead. There is no predicate, and if Actiband could be used, it becomes an adulterated product in a few weeks anyway.
* And, last but not least, to 7Up - Your information, as always, is incorrect. END
Amazing due diligence from knowing whether meeting are taking place or not to what the next news from BIEL will be. Are you absolutely confident your due diligence is solid? I believe there are errors throughout. Tenacious effort, but the information must be accurate and veracious and I doubt very much that it is, without substantiation.
Unquote my previous post
Now you say, "I'm confident that the 510K is dead, yes. Absolutely confident." That is a 180 degree reversal, called backtracking in many circles.
No one asked you if you were confident - you posted content as a statement of fact, unsolicited. I was pointing out my opinion that numerous statements of fact that the 510(k) is dead were wrong and therefor misleading. I gave you the benefit of any smidgen of doubt I could muster, in the name of common decency, that you may have been misled by others, rather than suggesting you were embellishing or inventing.
