我地隻scam
$SENS post 34 - Sens or Scam?
哥瑪先生monge
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phun dwac來料
我地隻scam
我地隻scam
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
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
$1.8可以嗎
no
其實4月中定尾已經filed，有專人正式開始review
其實4月中定尾已經filed，有專人正式開始review
咁都唔係耐
FDA講緊極速半年，快則一年，慢則三五七年
FDA講緊極速半年，快則一年，慢則三五七年
2.1-2.5 加埋最後
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
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
照咁講法，應該真係最遲今個月有決定
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.
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.
一句delay due to COVID搞掂
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
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
琴晚跌10%算唔算異動
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
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大晒個市閪到咁
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
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
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
過咗fda無返一倍真係唔知買嚟做咩但琴晚好多都跌得勁
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)
- 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)
at least唔會係問題accuracy / safety依啲咁fundamental嘅嘢
早知玩6969 rlx仲好
我要食零子煙呀！
我要食零子煙呀！
電
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