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