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Gold/Mining/Energy : Zentek Ltd.
ZEN.V 1.100+5.8%3:59 PM EST
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To: ValuHunter who wrote (49429)8/26/2024 12:08:08 PM
From: ValuHunter1 Recommendation

Recommended By
Reflection

   of 54588
 
Message #49429 from ValuHunter at 8/25/2024 12:39:15 PM
As of tomorrow we have been 118 days assuming May 1 as the start date. Given the FDA review outlined in the table below we should have had an answer on our HS/Zentek FDA application. A quick read suggests that we have probably been requested to submit additional information or other issues have come up regarding the application. Lets hope whatever the problems were, they have been dealt with expeditiously.

However, I have to wonder why we did not apply for this FDA approval immediately after securing the Health Canada stamp of approval.

I agree 1lastswing, we could see something on the FDA front any day now.

VH

OK this post of mine in response to 1lastswing is inaccurate as well for the same reason.

Regulatory

ZenGUARD™ Enhanced Air Filters are currently being assessed by the Health Canada Pest Management Regulatory Agency (PMRA) for registration under the Pest Control Products Act. Zentek will provide an update as soon as it is available.

Zentek is also currently working with consultants to file an application for ZenGUARD™ Enhanced Air Filters with the United States Environmental Protection Agency.

Additionally in April 2024, the Company filed a 510(k) application with the United States Food and Drug Administration (FDA) for ZenGUARD™ Surgical Masks. The Company was required to complete additional safety and performance testing for the application to the FDA. The Company has previously announced distribution partnerships for the United States market with Henry Schein and Medwell Solutions pending FDA clearance and will continue to explore other distribution channels.

Again the importance of posting the facts.

VH
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