RSH 5.06% 8.3¢ respiri limited

We want answers

  1. 27 Posts.
    lightbulb Created with Sketch. 5
    Marjan Mikel informed attendees at the NWR virtual conference that he will have FDA approval before the end of this quarter as promised.The very concerning issue is the FDA decision was made 11/03/21 8 days prior and volume increased dramatically. Why a trading halt on the 19th after the presentation ????

    510(k) Premarket Notification (fda.gov)

    Under Listing Rule 3.1, an entity must disclose all information concerning it that it becomes aware of from any source and of any character, if a reasonable person would expect the information to have a material effect on the price or value of its securities.

    https://youtu.be/-sc8um4H584

    Device Classification Name
    Abnormal Breath Sound Device510(K) NumberK202062Device NameWheezo WheezeRate DectorApplicant
    Respiri Limited
    1Level 10, 446 Collins Street
    2Melbourne, AU 3000
    Applicant ContactSamaneh SarrafCorrespondent
    Respiri Limited
    1Level 10, 446 Collins Street
    2Melbourne, AU 3000
    Correspondent ContactSamaneh SarrafRegulation Number868.1900Classification Product Code
    PHZ
    Date Received07/27/2020Decision Date03/11/2021DecisionSubstantially Equivalent (SESE)Regulation Medical SpecialtyAnesthesiology510k Review PanelAnesthesiologyTypeTraditionalReviewed By Third PartyNoCombination ProductNo


    Be great to hear a detailed response from Yenom23 Lucius vorenus Lucasq and all other Respiri investors on this issue
    hope everyone is having a restful weekend


    Last edited by mavericktrader4: 21/03/21
 
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