IBX 2.44% 8.0¢ imagion biosystems limited

Hi all,We see that there has been a lot of interest in an update...

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    Hi all,

    We see that there has been a lot of interest in an update from the Company on our HREC submission.

    We are sensitive to the anxiety that the lack of a formal announcement might create and wanted to assure our shareholders that, at this point no news is simply “no news”. That is, there is no material change from our previous disclosures. We hope the following might provide some additional clarity on the HREC review process.

    The purpose of the Human Research Ethics Committee (HREC) is to review the scientific validity of the trial design, evaluate the balance of risk versus harm for the patient, affirm the ethical acceptability of the proposed trial, and approve the trial protocol. On 5 August we announced that we had successfully submitted the necessary documents for our Phase I Study to a Human Research Ethics Committee for review.

    Once submitted, the Committee is obligated to provide feedback to the study sponsor in a timely fashion, but the overall process may take 60-120 days depending on the level of complexity of the study and the risk to patients. As per the normal process, we have received feedback from the Committee and are responding to their questions and clarifying specific aspects of the study.

    We will advise the markets once a formal determination has been made by the HREC with regard to our proposed study.

    In the meantime, and as always, thanks for your support of IBX.
 
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