InvestorsHub Logo
icon url

exwannabe

03/13/24 3:47 PM

#678365 RE: StonkMaster #678363

88% of NAS MAAs were assessed within 210 days (NOT including RFI clock-off time) in 2022-2023. Clock-off could account for an additional 60 to 120 days.


And most all were already approved by the EMA so the MHRA could leverage the CHMP(EMA) review.
icon url

meirluc

03/13/24 4:14 PM

#678372 RE: StonkMaster #678363

Thank you StonkMaster for your clarification. Based on
your assessment, beginning of July to the end of September
seems to be a realistic timeframe for MHRA approval.
Somewhat disappointed as I hoped for a sooner approval but
it is what it is. That also suggests to me that a combo trial
partnership is not around the corner because the remedial
work for approval will tie up the company for some time to come.

OTOH there are also Flipper's just posted 9 points suggesting an
earlier approval and we will see whether those points will be factors
that may allow the MHRA to come up with an earlier decision.
Bullish
Bullish