LDX lumos diagnostics holdings limited

what is BDI ? where are you getting these figures from ? where...

  1. 28,596 Posts.
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    what is BDI ? where are you getting these figures from ? where does it say 200m revenue ?

    I'm just reviewing and dont make heads nor tails of where you are referencing, base on the companies presentation or their web site,

    Just a look through, they are losing money at present, as most do. The Covid tests are down, etc.

    But what does catch my attention is the same that brought this out of its coma. The FDA clearance for FebriDX

    There are a few questions which the announcement leaves the door open on.

    "Following a presubmission meeting in January 2023, Lumos submitted a new 510(k) application for
    FebriDx to the FDA earlier this year. The FDA has completed its review of this new application and
    determined that FebriDx has demonstrated substantial equivalence to the predicate device cited in this
    application, and has consequently cleared it for marketing in the US. FebriDx is already registered in the
    UK, Europe, Canada, UAE, Brazil, Turkey, Pakistan, Singapore, Malaysia and Australia."

    If it is already registered , what does that mean ? Was it available for sales channels already ? or was it waiting for FDA clearance before it could have any sales in these other registered countries ?
    And who are the "equivalence to the predicate device" ? Who is the competition ?

    That is what is of interest to me. There is a big opportunity there, but it is unclear to me regarding these other countries sales then (when) and who they are competing against.

    If that is my quick look through, i look for the compelling reason to buy, against the current cash flow burn and loss making.

    Just a newbie, and the company need to present a case that makes it compelling.
    It should spell out the existing competition, the market share it is attempting to enter, etc.
 
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