Extracts from my expert testimony to Public Health Integrity Committee of Mississippi

Important facts you DO need to know

DECLARATION FOLLOWS:

• Based on my experience, knowledge, and training as a pharmaceutical and biologics supply chain management and regulatory specialist (CV here), it is my professional opinion that the following licensing, good manufacturing practice, quality control and product distribution standards, contained in the Federal Food, Drug and Cosmetics Act and the Code of Federal Regulations, Title 21, (FDAs section in the CFR), were not adhered to, with predictable harmful impact on patients:

• Typically, it takes 1 – 1.5 years for FDA to evaluate and approve an application to market a new drug. The EUAs were approved within weeks.

• Typically, it takes 10 – 12 years to develop a new drug once discovery research has identified a development candidate. The SARS-CoV-2 injections were developed and manufactured in unit-dose quantities in the billions, within 6 – 9 months.

• Further details on typical timelines can be found at