where do we go from now, page-5

Hi DBL1771,

You say..."I have to correct you on number one . The whole problem is that nothing is proven . Many members of the medical community are not convinced and the much needed FDA trial looks as if it could never happen.

To suggest that the technology is proven is misleading."

To set the context right, not supporting CCE, CCE' products have been used in various places including treating of burnt patients in Bali bombing. The technology is proven and as to why the uptake is slow we don't know. The only one in the medical community who is not convinced is concord hospital (has been a rival - so you don't get constructive comment from them). I am not sure where you get your information and undertake a thorough research.

In regard to FDA, it is a requirement by FDA if there is a competitor already selling tissue engineering product in USA to test for the efficacy of CCE' products. There is no requirement for CCE to do down the path of clinical test (this could takes 10yrs). All CCE need is to come up with 70 patients to conduct the efficacy of CCE's products and collated the results and presented to FDA for assessment and approval. So it is a blessing that CCE do not have to go through clinical test of their products. Getting the right numbers and meeting the criteria have slowed down CCE marketing into USA.