EBR 4.21% $1.03 ebr systems inc.

General Investor Information EBR Systems, page-248

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    I refer you to the 15 Nov 2023 release regarding the revised schedule for submission of the final module:

    "Sunnyvale, California; 15 November 2023: EBR Systems, Inc. (ASX: “EBR”, “EBR Systems”, or the “Company”), developer of the world’s only wireless cardiac pacing device for heart failure, wishes to provide a status update regarding the Company’s Premarket Approval Application (“PMA”) to the U.S. Food and Drug Administration (“FDA”).
    "EBR has submitted four out of five required modules for the PMA submission (as previously disclosed), and now expects to submit the final module in Q3 2024.
    "The updated timeline is a result of new information relating to the proposed testing schedule received from an expert consultant involved in the design verification testing required for the final module.
    "The new testing schedule has been expanded by a short period, meaning the final module will not be able to be submitted in Q1 2024.
    "However, EBR expects the new testing schedule to increase the strength of the Company’s PMA submission and place EBR in a better position to receive FDA approval without further delay.
    "The Company will continue to benefit from the FDA Breakthrough Device Designation. EBR’s clinical data remains unchanged with the pivotal study results meeting the primary safety and efficacy endpoints, while the costs of the planned expanded testing are minimal.
    "EBR is now targeting FDA approval during Q1 2025 and remains well funded through initial commercialisation."

    Whilst this announcement doesn't specifically state either Calendar or Financial year, I believe it relates to Calendar year. If you aren't convinced then I suggest you make an inquiry to the Company for clarification.

    With the release of the latest announcement re the appointment of the Chief Commercial Officer, once again there is no specific referral to Calendar or Financial year, but I read it as Calendar year. In part it states:
    "announce the appointment of Mr Erik Strandberg as Chief Commercial Officer (“CCO”) of the Company, effective as of 29 April 2024. Mr Strandberg will lead the Company’s US commercialisation strategy and will immediately focus on preparing the Company for product launch and commercialisation in early 2025."

    Thus i believe the FDA submission of the 5th (and final module) is scheduled some time between 1 July 2024 and 30 September 2024. John McCutcheon has mentioned a number of times that upon submission of the final module:
    1. It is not a matter of IF the WISE device is approved, but WHEN;, and
    2. He has allowed 6 months for the approval from FDA, but it could be sooner or later than 6 months.

    It is important to note that the Company achieved primary efficacy and safety endpoints in its pivotal SOLVE-CRT trial, paving the way for FDA approval.

 
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