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Explanation and Expectation, page-8

  1. 46 Posts.
    All,

    Maybe wrong here (please feel free to correct me this is all just my opinion) but my reading of the agenda quote ("EMEA/H/D/002831), ((substance to be reviewed) insulin-like growth factor-i (igf-i) segment), (hard-to-heal wounds, primarily venous leg ulcers) List of Questions adopted on 23.01.2014. • List of Outstanding Issues: For adoption") is as follows:

    1, A meeting was held on 23/01 at which point a number of question that the EMA would normally ask were agreed as being accepted whilst a number of outstanding questions were flagged as "outstanding issues" inhibiting approval.

    2. The response TIS provided in July now covers this "List of Outstanding Issues" which they will review in the meeting on Wednesday and choose to adopt or reject based on TIS having provided the right answers.

    I don't think anything has fundamentally changed here...i.e. a meeting was being run to see if TIS's responses were satisfactory and could facilitate formal approval - this agenda shows exactly that.

    D

    - DYOR i'm not a investment guru or scientist and the above is just my opinion
 
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