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Biotech / Medical : ADVR - Bulls no Bears
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To: OLD JAKE JUSTUS who wrote (570)5/15/1997 10:09:00 PM
From: .com   of 913
 
I agree with your speculation that they are probably working on an article for publication in a journal right now. They stated all along that would be the next step, but that study should have been completed months ago.

I never understood why publication in a research journal was the priority over filing for FDA approval. Perhaps they feel the FDA can't screw around with them if positive data is made public first.

Of course, another possibility is that is that the results aint so good. Hope not, for if it is true I am out alot of money.

As far as the need to test off-shore instead of the US because they don't have FDA authorization, you have to keep in mind that they haven't asked for FDA authorization, so I have problems making the FDA out as the bad guys yet. As I mentioned in a prior post, I have my own prior problems with the FDA, waiting over a year in extreme pain for a back surgery while they sat on an application from a company called Spine-Tech (SPYN) which they finally approved. So, I am as quick as anyone to jump on the FDA, but until ADVR makes a request or submits an application which is not responded to quickly, it is hard to blame the FDA; the ball is in ADVR's court.

Actually, I'd hate to see ADVR folks do any pre-emptive FDA bashing. I wouldn't want them to get pissed off at the company prior to receiving an application.

Thanks for the conversation. It is enjoyable communicating with someone as open minded as you.
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