Last night after reading C4, I decided to goback on few of company announcement to understand where are we withTGA application (no. days since first lodged).
Doingthis research, I discovered that company in their announcement dated2/July/2020 "Oncosil files for TGA registration" said thatthey have " As announced on 4 May 2020, OncoSil filedfor registrations in Singapore,HongKong and Malaysia;with approval in Singapore announced on 1 June 2020."
Announcementissued on 4th May 2020 says " Registrations filed forOncoSil in Singapore, HongKong, Malaysia; nowawaiting outcomes"
Nowback to 2021, and I have read few announcements between 2nd July 2020and 29th April 2021 and none of them (in my opinion) says thatcompany has received approval in Hong Kong... Pleasecorrect me if this is not the case... as I could have missedit.
Now, Registrationof medical devices in Hong Kong is overseen by the MedicalDevice Control Office (MDCO) asper https://www.emergobyul.com/resources/hong-kong-process-chart
Nowgo to the link above and approval process step 7 says "Step 7 :Upon approval,deviceis assigned a Hong Kong Medical Device number,and listed in MDCO database. Approvalis valid for 5 years.LRP must submit application for continuation of the listing to theMDCO at least 3 months prior to expiration."
Nowgo to Department of HealthWebsite https://www.mdd.gov.hk/en/mdacs/search-database/list-md/index.html?page=details&id=210136
Youwill see table with detail of OncoSil device. The key observationhere is that Listing No.(HKMDNo.) 210136 and databaselast update date "21/April/2021" and expirydate "21/April/2026....(Myassumption here is thatHKMD No. is same as what is mentioned in step 7 above "Hong KongMedical Device Number")... Sobasically OncoSil has HKMD No. and Expiry date is 5 year from2021.
Nowif we connect the dots and between table data and what is provided onstep 7 of the approval process, can we say that the company havereceived Hong Kong Device Approval but didn't issue market announcement or forgot about it?
PleaseDo Your Own Research before investing or divesting... !
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