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IMGGorBust

07/30/10 2:18 PM

#21525 RE: wizard69 #21522

Perhaps you should look up the distinction between a prediction and a statement of fact. I have a $20 bill in my pocket. I expect that I will win $20 from the lottery ticket in my pocket. One of them is a statement of fact known by the speaker to either be true or false when he says it. One is a prediction that cannot be known with any certainty. Let me know what your dictionary says.
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fink

07/30/10 2:37 PM

#21526 RE: wizard69 #21522

Well he knows the machine better than anyone here and nothing illegal about being positive. He feels approval is imminent, no matter how many times the FDA comes back with questions, Dean will hit em back with what they want till approval is given.

I think 3+ months ago we went throght this talk of , " if approval we will ......" then Dean came with his positive spin of not if but when.
Same thing I guees you are trying to wrap your mind around today.

You do know the FDA can come back with any question they want, like clolr choices and case textures that will be offeren? LOL!
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BigOwl47

07/30/10 3:47 PM

#21540 RE: wizard69 #21522

Dean and IMGG was in effect married to the old FDA Review team for better or worse. That marriage did not work out too well and there was somewhat of a divorce from the first review team.

Now Dean and IMGG are remarried to a totally new FDA Review team with better communication skills and a better potential relationship.

So, in effect, the FDA review taking 3 years due to Dean and IMGG is wrong on its face. The communication with the first team (wife #1) did not work out due to the first team having a lot of flaws. Once the FDA recognized what the problem was the marriage was terminated by the FDA (not Dean).

So the new review team (wife number 2) has been around for a little over 7 or 8 months and is working hard with Dean and IMGG to achieve a proper disposition of the community property (the FDA submission).

You can not blame Dean alone for the outcome of the first marriage since the FDA itself forced the divorce and terminated or removed the prior review team instead of finding DVis as NSE. I think this second marriage is potentially going to resolve the dispute over the community property and the time frame with the new review team is progressing nicely.

I'd say after the honeymoon of 9 to 10 months is over, we might begin to wonder, but for now, we simply need to let the marital relationship develop and see if romance and love are the result.

I, personally, am hoping for a fine second marriage and many wonderful 510-K children to come in the future.