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Short Activity in PNV, page-94

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    In the interests of keeping it friendly on the forum I will point you to some easy-to-find information that might help.

    Here is the text from the last two pages of the latest recent Results Presentation:

    [Business Outlook]
    FY21 – Market Expansion
    • Continue our NovoSorb BTM revenue growth trajectory in established markets
    • Open major European markets in the year ahead with a mix of direct and distributor models, key markets France, Benalux, Scandinavia, Italy, Greece and others
    • Open Taiwan H2
    • Korean entry possible H2 awaiting regulatory approval slowed by CoVid travel restrictions on Korean team, virtual audit
    17

    FY21 – Other Activities
    • Expand the R&D team H1 to accelerate new product pipeline developments
    • Commence recruitment in Pivotal Trial (BARDA) H1
    • Recruit patients in US chronic wound reimbursement study H1
    • Complete validation and testing of Syntrel hernia device early H2
    • File Hernia 510(K) with US FDA in June/July 2021


    Also from the annual report for FY20 outlining what has already happened: page 2
    Achievements
    CE Mark Approval
    FDA Breakthrough Device Granted
    Singapore Regulatory Approval
    First $2 million Month for Product Sales
    ASX200 Achieved
    UK First BTM Surgeries January 2020
    Germany First BTM Surgeries January 2020

    From the annual report for FY20: page 3
    Our BARDA program saw the completion of the feasibility burn trial and the filing of the pivotal trial integrated
    development environment (IDE). The US FDA also granted PolyNovo breakthrough technology status allowing us to
    have more frequent and direct interaction with the FDA teams. At this time we are awaiting final approval of the IDE.
    And the Chairman's report page 6:
    Our $15m USD BARDA funded US
    pivotal trial will begin recruitment in circa
    November, post US FDA approval of the
    IDE
    . The number of patients, number of
    sites and end points will be announced
    once we have the IDE.


    So in answer to your question - November is the earliest we might hear about any kind of announcement. That will not be a catalyst IMO.
    If we are very good boys and girls, we may get a Christmas present from DW of an announcement re break-even or a record sale quarter but I won't hold my breath personally.
    Last edited by strangelogic: typo fixed 31/08/20
 
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