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As positive as a FDA approval is, the impact is diminished if...

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    As positive as a FDA approval is, the impact is diminished if that is the announcement. At the very least I would expect a high level plan on entering the US market, with assumptions outlining commercial model, partnerships, pricing/ margin and indicative sales and market penetration first 12 months.
    Given the potential of the US market the numbers get big very quickly!
 
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