Hi toEire2011 and Sholtz .... and anyone else who might know ......

Hi toEire2011 and Sholtz .... and anyone else who might know ...

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I am tryingto understand just where we are at with the program of testing in the lead-upto hopefully getting full approval from the FDA to sell our valve into themarket in the USA...As Sholtz says "the study will evaluate safety andfeasibility ..." ... does that mean the patients given the valves inGeorgia 12+ months and also 8 months ago are "the study" meaning the"first study" which is recognised as valid by the FDA and mayallow the FDA to approve the next (ie second) study?

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Or was theGeorgia effort a preliminary effort so as to catch the FDA's attention and givesome credibility to Anteris's request to be allowed to perform the first (iesafety) officially recognised study?

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And what will be the timeline? .... as in ... we submit the study plan and then wait for a period of time to have FDA pass the evaluation of the first study and then we get on with (first or second?) study ... and then we do the study and wait ... and wait ... will it be 12 months after the patients are implanted at least before the FDA approval happens?

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Could someoneplease fill in the significant sequence of events on a timeline forme ....

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Thanks

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D