UCB(MedSku)
2021-12-2 18:54:43
no
其實4月中定尾已經filed，有專人正式開始review
Kapok
2021-12-2 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
豹2A7A1
2021-12-2 19:08:46
2.1-2.5 加埋最後
:^(
UCB(MedSku)
2021-12-2 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.
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.
伯爵茶奶凍
2021-12-2 19:25:32
一句delay due to COVID搞掂
:^(
Kapok
2021-12-2 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
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伯爵茶奶凍
2021-12-2 19:28:02
琴晚跌10%算唔算異動
:^(
:^(
:^(
南風微醺
2021-12-2 19:28:45
:^(
Kapok
2021-12-2 19:29:08
Jayson Bedford
And just to be clear, the hundred -- the clock started in mid-April.
- 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).
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