Expert Group Defines Long COVID as “Infection-Associated,” Yet Also Acknowledges “Symptoms and Diagnosable Conditions Characteristic of Long COVID Can Have Alternative Origins” “As the number of cases of acute SARS-CoV-2 infection declines, an increasing fraction of patients with symptoms compatible with Long COVID will have their condition due to a […]
Follow-Up to “NAATs Used in Pfizer Clinical Trial to Test Asymptomatic Patients Despite Not Being Approved (or Even Emergency Use Authorized) for Asymptomatic Testing.”
Addendum: Since publication of this piece on April 25, 2023, a new Pfizer document tranche (dated April 3, 2023, but available publicly in late April 2023) has been released, and it included, “Report on Method Validation of a Cepheid Xpert® Xpress PCR Assay to Detect SARS-CoV-2.” The validation report states: “This report […]
FDA Response To Doctor Raises New Questions
FDA Response To Doctor Raises New Questions Due to my experience in the regulated industry of biotech/pharmaceuticals for over 25 years, I’ve felt obliged to point out apparent discrepancies between regulations and practice to the FDA over the past year and a half. Below is one of those letters […]
FDA and Pfizer Data Allegedly Missing IMPORTANT Blood Brain Barrier Data – Letter
Dr. Peter Marks, Director of the Center for Biologics Evaluation and Research (CBER) Food and Drug Administration Dept. of Health and Human Services (HHS) Peter.Marks@fda.hhs.gov April 16, 2022 Dear Dr. Marks, I’ve just read an article stating highly inflammatory lipid nanoparticles (LNP)s “could be responsible for adjuvanticity and some […]