關於金萬林的FDA EUA - 股票

By David
at 2020-05-27T19:25
at 2020-05-27T19:25
Table of Contents
等了一個禮拜
版上最早的新聞
https://i.imgur.com/uud0w2i.jpg
https://m.cnyes.com/news/id/4480181
標題很聳動
但不得不說金萬林是無辜的
金萬林在5/20最早的公告
https://i.imgur.com/d184rOe.jpg
申請EUA、符合FDA規範、許可使用
沒有提到"核准"
接下來是一連串的澄清公告
5/21
https://i.imgur.com/sSUrxPu.jpg
申請EUA、符合規範、許可
https://i.imgur.com/SPVz67n.jpg
同意PacGenomics使用
5/22
https://i.imgur.com/zz4gjKs.jpg
符合規範,並"通用"EUA核准,許可
通用這個字很曖昧呢
5/25
https://i.imgur.com/XfbReCT.jpg
申請EUA、符合規範、同意
同意PacGenomics使用
核准兩個字又不見了
FDA EUA頁面咕狗就有
https://i.imgur.com/Kc6bDz7.jpg
沒有
最後在某個地方找到了
FAQs on Testing for SARS-CoV-2頁面中
https://i.imgur.com/IFKt5Rp.jpg
https://i.imgur.com/ayEZuIw.jpg
建議去頁面看整段說明
以下是節錄
Where the Authorization Status is "FDA Authorized," the FDA reviewed and issue
d an EUA for the test after notification was given. Where the Authorization St
atus is shown as "Not FDA Authorized," the FDA has not yet reviewed the labora
tory's validation and issued an EUA for the laboratory's test, and the test is
included in this list to provide transparency regarding the notification subm
itted to FDA.?
以官方公告為準對吧?
那依照FDA EUA的頁面
目前是"尚未核准"(只是尚未喔,非不)
金萬林的公告也都盡量避開了核准兩個字
沒準大概過幾天就會取得了
不用怕
我只是想說金萬林也是無辜的這件事
多補充一下
類似的情況在基亞(德必碁的抗體快篩)發生過
但基亞的澄清就非常明確
新聞截圖
https://i.imgur.com/E8dELsG.jpg
基亞澄清文
https://i.imgur.com/tZlClVh.jpg
取得EUA notified,而非EUA Authorized
另外TBG的產品也是在FAQ那個頁面可以找到
在血清學產品那項
https://i.imgur.com/axSXPzU.jpg
簡單說,用許可、核可、通知等有點不明確的中文字
會容易讓人誤會
且不能用核准、授權之類明確的字眼
--
版上最早的新聞
https://i.imgur.com/uud0w2i.jpg
https://m.cnyes.com/news/id/4480181
標題很聳動
但不得不說金萬林是無辜的
金萬林在5/20最早的公告
https://i.imgur.com/d184rOe.jpg
申請EUA、符合FDA規範、許可使用
沒有提到"核准"
接下來是一連串的澄清公告
5/21
https://i.imgur.com/sSUrxPu.jpg
申請EUA、符合規範、許可
https://i.imgur.com/SPVz67n.jpg
同意PacGenomics使用
5/22
https://i.imgur.com/zz4gjKs.jpg
符合規範,並"通用"EUA核准,許可
通用這個字很曖昧呢
5/25
https://i.imgur.com/XfbReCT.jpg
申請EUA、符合規範、同意
同意PacGenomics使用
核准兩個字又不見了
FDA EUA頁面咕狗就有
https://i.imgur.com/Kc6bDz7.jpg
沒有
最後在某個地方找到了
FAQs on Testing for SARS-CoV-2頁面中
https://i.imgur.com/IFKt5Rp.jpg
https://i.imgur.com/ayEZuIw.jpg
建議去頁面看整段說明
以下是節錄
Where the Authorization Status is "FDA Authorized," the FDA reviewed and issue
d an EUA for the test after notification was given. Where the Authorization St
atus is shown as "Not FDA Authorized," the FDA has not yet reviewed the labora
tory's validation and issued an EUA for the laboratory's test, and the test is
included in this list to provide transparency regarding the notification subm
itted to FDA.?
以官方公告為準對吧?
那依照FDA EUA的頁面
目前是"尚未核准"(只是尚未喔,非不)
金萬林的公告也都盡量避開了核准兩個字
沒準大概過幾天就會取得了
不用怕
我只是想說金萬林也是無辜的這件事
多補充一下
類似的情況在基亞(德必碁的抗體快篩)發生過
但基亞的澄清就非常明確
新聞截圖
https://i.imgur.com/E8dELsG.jpg
基亞澄清文
https://i.imgur.com/tZlClVh.jpg
取得EUA notified,而非EUA Authorized
另外TBG的產品也是在FAQ那個頁面可以找到
在血清學產品那項
https://i.imgur.com/axSXPzU.jpg
簡單說,用許可、核可、通知等有點不明確的中文字
會容易讓人誤會
且不能用核准、授權之類明確的字眼
--
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