RCE recce pharmaceuticals ltd

Ann: Positive Safety Data from Phase 1 Clinical Trial, page-112

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    Summa Summarum, I would state that if the burn study is concluded with 100% (or in that range) success rate, we have all the justification to apply and obtain all of the above. In addition, management could already start the application during the trial with the existing data, as stated above. So we could reach the US market very fast.

    As to the sepsis study, we don´t have any trial data on efficacy yet, but there could be enough ground to have the next trial approved by the FDA as a pivotal phase 2 study with all the above being approved as the study proceeds with good results comparable with the burn study.

    I will not comment the Australian market, since I have no experience at all with that process.
 
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