$SENS post 34 - Sens or Scam?

1001 回覆
6 Like 0 Dislike
2021-12-02 18:47:27
phun dwac來料

我地隻scam
2021-12-02 18:53:28
暫時依隻股睇唔到有咩問題
睇返conference個總結,佢哋submit完application後,得一半時間真正做緊嘢,到今年夏天先真正派到去比一個專人負責,我當6月,其實真正review咗半年都唔夠
2021-12-02 18:53:44
$1.8可以嗎
2021-12-02 18:54:43
no
其實4月中定尾已經filed,有專人正式開始review
2021-12-02 19:03:11
咁都唔係耐
FDA講緊極速半年,快則一年,慢則三五七年
2021-12-02 19:08:46
2.1-2.5 加埋最後
2021-12-02 19:11:21
唔係話潑冷水

FDA Action On a PMA
Within 180 days of the date of filing of the PMA (§814.40), FDA will complete its review of the PMA and of the advisory committee`s report and recommendation and issue one of the following:

an approval order under §814.44(d),
an approvable letter under §814.44(e),
a not approvable letter under §814.44(f), or
an order denying approval under §814.45.

https://www.fda.gov/medical-devices/premarket-approval-pma/pma-review-process#steps

持有數千股2.7成本
2021-12-02 19:19:22
照咁講法,應該真係最遲今個月有決定
2021-12-02 19:25:21
咁由因為疫情而推遲,依段嘢已經唔成立

Tim Goodnow

Yes, so as you know, a review such as this is a PMA supplement. It's not a primary review. PMA supplements typically would be a 180-day review. So we don't have a reason to believe that it should vary from that other than the dynamics of COVID and what it might take particular review or review team's time to clear off their desk from some of the prior work they were doing. So that's what we really don't know.
2021-12-02 19:25:32
一句delay due to COVID搞掂
2021-12-02 19:27:02
anyway,我信今個月至下個月會有決定
另外,除非真係有重大缺憾,如果唔係FDA review過程中一般係 0 消息,真係到announce result前一日隻股先會異動,no news is good news
2021-12-02 19:28:02
琴晚跌10%算唔算異動
2021-12-02 19:28:45
2021-12-02 19:29:08
Jayson Bedford

And just to be clear, the hundred -- the clock started in mid-April.

由4月中起計已經超過咗180日 COVID大晒
2021-12-02 19:29:25
個市閪到咁
2021-12-02 19:30:29
你睇下其他股先
如果到有一日升返晒,得佢跌10%,就真係異動,
同埋以我觀察,無論approve/reject,個異動多數係升
2021-12-02 19:30:39
其他撚嘢又會一早過咗過咗fda無返一倍真係唔知買嚟做咩
2021-12-02 19:30:47
但琴晚好多都跌得勁
2021-12-02 19:33:32
其實依段值得咬文嚼字

- FDA - PMA. The 180-day product has already been distributed for review. The lead reviewer who reviews sections of the applications is now coming back and forth with questions. Based on the scope of the questions being asked, they expect that they are heading towards the end of the year for approval or closely thereafter (but no promises).

scope = 問題方向,即係話根據FDA問嘅問題,佢哋覺得年尾前搞得掂,
可能已經問緊啲marketing / support嘢 (個人鳩估)
2021-12-02 19:34:36
at least唔會係問題accuracy / safety依啲咁fundamental嘅嘢
2021-12-02 19:37:24
早知玩6969 rlx仲好
我要食零子煙呀!
2021-12-02 19:37:36
2021-12-02 19:37:50
2021-12-02 19:44:20
部機一直都係歐洲賣緊,基本上都唔會擔心過唔到,係唔知佢仲等緊乜
2021-12-02 19:56:00
個市咁既樣
一陣過FDA可能都上唔返ER個頂 $4.2X
到時就變真價投10年了
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