PNV 0.41% $2.45 polynovo limited

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    The company in its last FY report (16 August 2018) stated, "We anticipate filing our US FDA 510(k) in FY20." (p.5)

    The 510(k) process takes 90 calendar days from the date of application. That duration can be extended by pausing for receipt of further information etc.

    In the last HY report (21 February 2019) they stated that, "The first Hernia product is scheduled to be on the US market in June/July 2020."

    Putting these two pieces together, I expect that the company should be aiming to file the 510(k) submission by the end of this year.


 
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