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fink

09/27/10 1:36 PM

#27840 RE: adrian taylor #27839

For Dean its a 65Million share gamble then.

Again, I would have trimmed 10,20Million at the high. Hell $3.00 with approval is the understood pps. He should have bailed some if he knew this was a long shot and one big FDA fake out.
The fact that he didn't says enough for me to hold what I have worked for and buy more on dips.
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BennyJ

09/27/10 1:37 PM

#27841 RE: adrian taylor #27839

what do you know about FDA? Have you ever filed any 510k with FDA before?
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pendragon8062

09/27/10 1:46 PM

#27842 RE: adrian taylor #27839

The old FDA team was corrupt and removed. Therefore, we had a "clean slate" for the April 5th submission. That's what we should be counting from.

The FDA took 183 days to issue an SE for a simple x-ray machine. That should speak volumes of how long their "due process" is.

As far as "freaking them out", yes, when you are awaiting regulatory approval, or being awarded a contract, or anything else of a fundamentally business making/breaking decision, you don't rock the boat. Simple common sense.
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borntwice

09/27/10 2:59 PM

#27849 RE: adrian taylor #27839

ADRIAN:

No need to fear total rejection, Dean said we can keep on submitting forever...

The Money TV spot las t week @ 19:33 Dean stated:

"What I try to tell people is they will never totally deny us, if they don't like our package now, we can refile again, and that's the whole point of the 501(k) process is to find something you can compare the device to..."

No ytotal rejection, if the FDA doesn't like it, tweak something and resubmit..