Saturday, November 12, 2022 5:40:32 PM
Not they are not. They are ATL insider saying LL said this.
We have no info on what she allegedly said before or after that.
As for timeline:
- There is a "Pre MAA Submission" timeline to follow.
+
An MAA submission timeline to follow. (including stop clock)
They submitted their Pip plan in Feb 2022. Which mean they started working on "pre MAA submission package in" ~ Oct 2021. (make sense). Their goal was to submit MAA in Sep2022. So they might announce MAA submission with JA next. (hopefully). Then we know we are ~ 8-12 months away from aproval or refusal. Would be nice to have a look at JA before this time, so we have a better idea about pulling out or keep being invested.
See this link for timeline:
https://www.propharmagroup.com/blog/roadmap-to-authorization-using-science-to-prepare-a-maa/
We have no info on what she allegedly said before or after that.
As for timeline:
- There is a "Pre MAA Submission" timeline to follow.
+
An MAA submission timeline to follow. (including stop clock)
They submitted their Pip plan in Feb 2022. Which mean they started working on "pre MAA submission package in" ~ Oct 2021. (make sense). Their goal was to submit MAA in Sep2022. So they might announce MAA submission with JA next. (hopefully). Then we know we are ~ 8-12 months away from aproval or refusal. Would be nice to have a look at JA before this time, so we have a better idea about pulling out or keep being invested.
See this link for timeline:
https://www.propharmagroup.com/blog/roadmap-to-authorization-using-science-to-prepare-a-maa/
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