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Gold/Mining/Energy : Nuvo Research Inc -- Ignore unavailable to you. Want to Upgrade?


To: Mark Bartlett who wrote (1661)4/17/1999 1:55:00 PM
From: Montana Wildhack  Read Replies (1) | Respond to of 14101
 
Mark,

I'm sure I heard that the FDA had come up earlier and
I thought I'd read it on this thread that Peter said
Dimethaid had answered those questions (five or
six months ago)?

I don't know the exact blend of criteria the FDA will
use, but, I've got to believe study size has been
long looked at and is one of those continue/stop
points early in the process.

Why visit the manufacturing site? Because the size
of the Pennsaid studies is not at issue with the
FDA. My opinion.

I've heard enough to believe we're at the point
of arranging with the HPB for the FDA to visit the
site - not talking sample size.

However, I agree Dimethaid has been weak in getting
attention in an acceptable way. Look at the human
interest story they got in. She's playing the piano
again! Brilliant! Not worried though. This market
is SO big.