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Ann: Update on Submission of Final Module to FDA, page-20

  1. 4,579 Posts.
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    Certainly the announcement yesterday means a deferral to the FDA approval, and that obviously is disappointing with the market reacting accordingly.

    I thought it best to gain further insight to the particular issue before coming to any conclusion and sent off an email earlier this morning. Within a few hours I had a response from Andrew Shute, Senior Vice
    President Field Operations:

    "This is isolated to a testing delay with one of our vendors. Specifically, this is an abrasion test that is performed on the cable that connects the Transmitter to the Battery.
    We had underestimated both the start date for the test, and the duration of the testing period.
    "We have indicated final submission will occur during Q3 2024, but our team will continue to try to get the submission in as early as possible.
    "The rechargeable battery project remains on track. We expect to receive working prototypes next year to begin design verification.
    "Regarding finance, with the delay to FDA approval, we are able to defer some of our planned expenditure (eg sales heads). We are still forecasting cash through to late 2025."

    So whilst it's an issue to be dealt with, and does impact timing somewhat, it isn't as though the world has ended!

    Also the TA didn't predict this - in other words this more than likely came out of the blue, or certainly was not common knowledge by inside investors.
 
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