questions remain unanswered

Disappointing these issues were not addressed during the Q&A on the 23/3 after many questions were submitted prior to the zoom call. IMO this will be below 8 cents very soon with the 6-8 million revenue guidance only in shareholders dreams at night. FDA was supposed to be the pinnacle moment for Respiri, however the firework failed but still provided a rich exit point for the smart ones. good luck to all


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)

UnderListingRule 3.1, an entity mustdiscloseall 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 DectorApplicant

	Respiri Limited
	Level 10, 446 Collins Street
	Melbourne, AU 3000

Applicant ContactSamaneh SarrafCorrespondent

	Respiri Limited
	Level 10, 446 Collins Street
	Melbourne, AU 3000

Correspondent ContactSamaneh SarrafRegulation Number868.1900Classification Product Code

	PHZ
No data available in table

Date Received07/27/2020Decision Date03/11/2021DecisionSubstantially Equivalent (SESE)Regulation Medical SpecialtyAnesthesiology510k Review PanelAnesthesiologyTypeTraditionalReviewed By Third PartyNoCombination ProductNo