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learningcurve2020

05/12/24 10:19 AM

#690827 RE: beartrap12 #690824

Much of the "vaccine" for the Plll was produced by Cognate so they'll want to see the facility. Cognate was sold years ago by LP and others.

Reefrad

05/12/24 11:59 AM

#690835 RE: beartrap12 #690824

Or just that the data for approval was largely based out of the US so the UK regulators may want to examine those sites as well.

XMaster2023

05/12/24 12:27 PM

#690839 RE: beartrap12 #690824

Inspections for export of human tissue and import of vaccine?
Bullish
Bullish

NotSure2

05/12/24 12:41 PM

#690845 RE: beartrap12 #690824

Has nothing to do with thinking ahead for an application to the FDA.

If you look at the trial location sites, youll notice that ~70 of the 86 locations are in the USA.

This is why they are dealing with lots of experts from the U.S.A.

https://www.clinicaltrials.gov/study/NCT00045968#locn

Only 4 in UK, 9 in Germany, 2 in Canada. 71 in USA. (hospitals/university/etc...)

The Company does not know when MAA - related inspections may take place.