Nearest the pin for Smrtgraft Tendon Repair Approval date, page-7

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    131 TGA business days is the average time for the TGA review (excluding any back and forth). Assuming no follow up queries from the TGA, that would have taken us to around 11 December 2024. Obviously that’s just elapsed.

    A couple above have the pin in February 2025, which I’m inclined to agree that that is reasonable, with the holiday period upon us.

    Good thing is 255 TGA days is the maximum time the TGA can take for its review. So the absolutely latest time they should get back to us by is around 11 June 2025, assuming no back and forth. I don’t believe they will take this long, with our platform already approved twice by them and the product being used under the SAS.

    Finally, it doesn’t sound like there is, or has been, any further material questions from the TGA - JVW mentioned in the recent Talk Ya Book interview that it’s currently sitting with the TGA and they are just waiting on the outcome which can be any day.

    Bring on CY2025!
 
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