This also means there was fraud. The clinical trials are invalid. They were based on Process 1 drug product that could not be manufactured at commercial scale. There's not only lot to lot variation but there is also two manufacturing processes, there were no bridging studies to show that the product assessed for safety and efficacy is th…
This also means there was fraud. The clinical trials are invalid. They were based on Process 1 drug product that could not be manufactured at commercial scale. There's not only lot to lot variation but there is also two manufacturing processes, there were no bridging studies to show that the product assessed for safety and efficacy is the same quality and strength as the product they use in the general population. FOI requests in Australia also demonstrate incredible lot to lot variation. This article explains it well. Also Senator Rennick put the TGA on notice on this exact issue. Add this to the reason the house of cards is falling. https://pfizersibilusceraula.substack.com/p/breaking-leaked-eu-regulatory-report
This also means there was fraud. The clinical trials are invalid. They were based on Process 1 drug product that could not be manufactured at commercial scale. There's not only lot to lot variation but there is also two manufacturing processes, there were no bridging studies to show that the product assessed for safety and efficacy is the same quality and strength as the product they use in the general population. FOI requests in Australia also demonstrate incredible lot to lot variation. This article explains it well. Also Senator Rennick put the TGA on notice on this exact issue. Add this to the reason the house of cards is falling. https://pfizersibilusceraula.substack.com/p/breaking-leaked-eu-regulatory-report