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Ann: Extension of Convening Period for 2nd Meeting of Creditors, page-3

  1. dc3
    109 Posts.
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    My sense unfortunately is that approval won’t occur by then.

    TGA publishes their minimum required approval timelines and based on that I would expect it to be closer to 12 months from the initial pre-submission meeting. New novel treatments are also stated to take longer than subsequent product approvals.

    However I don’t disagree that there will be further certainty on this process by then which will be helpful to all this.
 
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