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Biotech / Medical : Biofield may double within 3 months!
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To: Haolin Ni who wrote (77)2/28/1997 4:36:00 PM
From: damniseedemons   of 120
 
I listened to their brief conference call:

They were as blindsided by this as everyone else.

The FDA is questioning the algorithms (they way that the scanner date is interpreted) that BZET used in their clinical trials. The FDA didn't want to algorithms to be based upon the clinical trials, but a different data set.

The strange thing, is that BZET swears that they followed all procedures correctly, and said that what the FDA thinks is just a "misunderstanding," or "miscommunication."

They went on to say that they were "confident" that it was just a technical problem (the algorithm), and not a problem with the scanner or anything.

My take: I can't believe that a simple "misunderstanding" has caused this problems--but that's what BZET says. Also, they are approved in Europe and are looking for a European partner to help them sell their equipment (marketing and stuff)--at least they still have that!

BZET has about $3 in cash, so that's around where the downside is (I suspect that it will continue to drift until the final verdict comes). Now, BZET has 10 days to respond to the FDA's concerns, and will do so immediately. Then the FDA has 10 days to make their decision. If they don't approve, then it's back to square one for BZET--they'll have to do their clinical trials all over again (length of time for this depends on how many people the FDA tells them to test it on--they guessed that it could be several months, or even a year or so).
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