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Biotech / Medical : Gliatech (GLIA) -- Ignore unavailable to you. Want to Upgrade?


To: lrb who wrote (603)2/5/1999 1:22:00 AM
From: scaram(o)uche  Respond to of 2001
 
from the S-3.......

APPROXIMATE NUMBER OF
SURGERIES PERFORMED
PRODUCT SURGICAL APPLICATION STATUS(1) ANNUALLY IN THE U.S.
- ------------------------------------------------------------------------------------------------------
<S> <C> <C> <C> <C>
ADCON-L Lumbar surgeries Approvable letter received from 450,000
the FDA in April 1998

Marketed in 29 countries outside
the U.S.

ADCON-P Pelvic/gynecological U.S. pilot clinical trials 1,300,000
surgeries underway

ADCON-T/N Tendon and peripheral U.S. pivotal clinical trials 260,000
nerve surgeries of the underway
hand

Marketed in 29 countries outside
the U.S.

ADCON-A Abdominal surgeries Preclinical research 2,500,000

ADCON-I Implant/prosthetic Preclinical research 1,400,000
surgeries

ADCON-C Cardiac surgeries Preclinical research 1,000,000



To: lrb who wrote (603)2/5/1999 1:26:00 AM
From: scaram(o)uche  Read Replies (1) | Respond to of 2001
 
Mike is correct..... there was no post-approval requirement for further study. However, this sort of data would be necessary for decent penetration.

Seems like this data would suffice for reimbursement in Germany??