approval, page-3

Hi smokey ,all I know is that will be in the first Q, heres the announcment from 9th Jan

Friday 9th January 2004, PERTH, AUSTRALIA: Clinical Cell Culture Ltd (C3, ASX:CCE)
today announced that CellSpray® and CellSpray® XP have been approved for market
launch in Germany and Austria, subject to the Belgium Health Authority issuing a GMP
manufacturing certificate for the products.
Troels Jordansen, CEO said, “We are very pleased to have this first independent
verification of our commercial and regulatory strategy. Targeting Europe prior to the
USA will enable C3 to bring revenues on-line sooner than if we had pursued a USA
regulatory strategy as our initial primary market.”
The German and Austrian markets have a combined population of 90.4 million people
with 36 burn centres; this will provide C3 with the opportunity to achieve a diversified
revenue stream to C3’s current Australasian based markets.
Troels Jordansen, CEO said, “Obtaining national approvals prior to the GMP certification
also provides us with an additional four to eight weeks prior to the launch to boost our
marketing activities and build our customer base.”
On 10th September 2003, the CellSpray® products registration dossier was submitted by
our production partner Cambrex Bio Science Verviers Sprl (“Cambrex”) to the Belgium
Health Authority. During December 2003 we received our initial feedback from the
Belgium Health Authorities inclusive of some routine queries. The response to these
queries is being expedited and we are confident of receiving approval in Q1 2004.
As noted in our ASX release on 10 September 2003, Cambrex received GMP approval
from the Belgium Health Authority for their newly constructed tissue-engineering
laboratory in early 2003. The current review by the Belgium Health Authority is an
update on their GMP processes in relation to CellSpray® production.
The approval of commercial selling of these products in Europe will assist in the ongoing
process of seeking regulatory approval within the Asia Pacific region.
About C3
Clinical Cell Culture is a publicly listed biomedical company, which develops and
distributes tissue-engineered cellular products for autologous skin replacement.
The Company’s lead products and product candidates are CellSpray®‚ cultured
epithelial autograft spray suspension for the treatment of major burns and scars,
ReCell®‚ autologous cell harvesting device for the treatment of small burns, pigment
loss and scars and EpiGrow®, autologous epidermal derived fluid for the treatment of
chronic wounds. C3’s products have been used on more than 1,600 patients to date.