EMA recently released highly important but outdated CTD quality documents from 2020, despite important new information in these sections. New FOIA requests are therefore pending.
Committee for Medicinal Products for Human Use (CHMP), EMA/CHMP/21199/2024, Type II variation assessment report, Procedure No. EMEA/H/C/005735/II/0202 (29th February 2024) = on SV40 Variation!!! Important!!! - Diskussed here: https://drbine.substack.com/p/pfizer-gibt-den-sv40-promotor-in
Hello Silvia, do you have any Endotoxin measurements from the 10 different testing site locations mentioned in the latest documents?
Dear Geoff, unfortunately not...hope we can find them somewhere!?
Committee for Medicinal Products for Human Use (CHMP), EMA/CHMP/21199/2024, Type II variation assessment report, Procedure No. EMEA/H/C/005735/II/0202 (29th February 2024) = on SV40 Variation!!! Important!!! - Diskussed here: https://drbine.substack.com/p/pfizer-gibt-den-sv40-promotor-in
Thanks, I liked your valuable analysis!!!