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more bad news Sydney - Monday - January 16: (RWE Aust Business News) - Clinical
Cell Culture Ltd (ASX:CCE) said the United States Food and Drug
Administration (FDA) has completed its review of ReCell and has indicated
that additional performance data is required.
Specifically, the FDA has stated that the additional clinical
data is required to allow it to make a determination of "substantial
equivalence".
Substantial equivalence is a unique FDA and 510(k) requirement
that allows a product to be marketed if it can be demonstrated that its
mode of action is the same as an already registered product.
This is a common route to market which is faster and more
economic than a full pre-market approval (PMA).
The performance data requested to determine this will be derived
from a clinical study, the details of which will be determined after
discussions with the FDA.
Guidance on the performance data required has already been
provided by the FDA and includes additional clinical assessment of graft
loss, scarring, infection and time to complete epithelialisation (wound
closure).
The FDA at this time point has identified no other issues or
concerns.
Managing director Troels Jordansen said that the delay in the FDA
clearance was clearly disappointing but the FDA clearance process had
proved extremely complex and the approval timeline was taking longer than
previously understood.
He said C3 was fully committed to the US regulatory approval
application.
In relation to the application to the Australian Therapeutic
Goods Administration (TGA) for ReCell clearance, Mr Jordansen said C3
continued to work closely with TGA to resolve questions raised in late
December 2005.
"This work is on schedule and C3 is confident it will
successfully address all issues raised," he said.
"A final decision from the TGA is expected in the first half of
2006."
Mr Jordansen said ReCell continued to penetrate several major
markets in Europe and Asia-Pacific and C3 will provide a detailed update
at the end of January in conjunction with the quarterly report.
C3 shares last traded at 23.5c.