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Ann: Resignation of CEO, page-27

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  1. 5,181 Posts.
    lightbulb Created with Sketch. 2501
    I'm not sure those views are entirely justified... although maybe...
    The troubles really began when our original HREC submission was knocked back on several points, as explained by Dr Rennie after Matt Liddelow resigned:
    1. Safety: localised irritation at the injection site was observed.
    2. Efficacy: the committee requested additional data to demonstrated the chemical was potentially efficacious.
    3. Purity: "contaminants" were detected in the treatment formulation.

    Point 1 was easily dispensed with.

    Point 3 should have been easily dealt with too as the "contaminants" were inactive manufacturing byproducts. As I remember it, the committee only listed them as contaminants because they weren't listed amongst the compounds expected to be in the treatment formulation. I put that down to inexperience at the NSB end, not knowing to ask for a complete list of expected components in the formulation.

    Point 2 was the biggy that done the whole deal in! The original thesis (here) quite clearly states this:
    Furthermore, in a comparison of two EmtinB forms; a tetrameric, 4 -peptide form and adimeric, 2-peptide form, the dimeric EmtinB peptide was shown to be considerably moreprotective than the tetrameric form. [The underlining and bolding is mine]

    And yet NSB chose to proceed with the tetrameric form, referred to in NSB literature as the "dendrimer" form. I presume this decision was made to accommodate issues with manufacturing the chemical, or with stability in storage. In section 3.3.7 the thesis directly compares the tolerance of healthy nerve cells against both forms of EmtinB (no difference) against the efficacy of each (shown below as fig. 3.9).
    https://hotcopper.com.au/data/attachments/5871/5871865-e55f93afa29a9d06872b8e0c1bad1c03.jpg

    Given that both forms were tested by Dr Eaton and results published in the thesis, and the differences clearly and explicitly highlighted, I find it quite astonishing that the company seemed to have been caught so completely flat-footed by the issue. The mistake has cost two years and pushed Alzheimer's and MS out the window as potentially achievable targets.

    So I feel that the company has bungled the work quite comprehensively, but I'm not convinced that you could call it criminal.
 
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