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maddogs

05/24/07 6:36 PM

#10342 RE: rocketeer357 #10341

" It was briefly mentioned in the PR that there was a possibility of the FDA wanting more data, but reading between the lines, it sounds like the FDA will want US of A results from studies done on humans."
Rocket.. that was a disclaimer. Granted, the FDA can do as it pleases, but really.....

"Was the company surprised to hear this news?"
What news? Since the submittal has not happened and the FDA HAS NOT SEEN an application, just how do you suppose the co. can "hear this news"?

Take heart in knowing a number of other co.s have broken the ground with RF electrosurgical practice and have the generators out in the thousands. The signal the ltc generator sends is the breakthru and the ltc gen. shows, while not signifigantly, none the less higher burst strengths.


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lowman

05/24/07 7:28 PM

#10343 RE: rocketeer357 #10341

Complete and/or total approval will probably require US testing, but I believe the first filing will be sufficient for minimally invasive uses, as well as duct/vessel sealing, which the only difference between existing technology and LTC is that existing technology currently only does 4mm-6mm (I believe) and LTC can do up to 13mm ducts/vessels.

As I said on the LMAO board, IMO, today's PR may have been done PRIOR to the filing, so's prospective buyers have a better gist of the potentials when they go to do their DD.

What the lame sellers of recent weeks fail to realize is that tissue welding is no new technology. LTC only vastly improves upon it, which is why it has so many more applications.

They also don't seem to realize that the filing WILL happen, and when it does, there should be a VERY nice bounce ($2-$3?) on just that alone.

FDA approval will trigger institutional buying, and since LTC has already been used in 7000+ operations, approval is almost a shoe-in, especially given Frank D'Amelio's record with obtaining FDA approvals.
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MALECUZ

05/24/07 7:48 PM

#10344 RE: rocketeer357 #10341

You must be the one that dumped today?