The FDA recently rejected and closed the application of a new drug that was proven to delay the onset of Type 1 Diabetes by at least two years.  Teplizumab was favored for approval in a vote by FDA's own advisory committee, accepted by the American Diabetes Association including adding to the Standards of Care for Type 1 Diabetes, and touted by the Dr. Kevan C. Herold from the National Institutes of Health as "a new era in the treatment and prevention of diabetes."  

Reasons for rejection are not based on safety or effectiveness.  This drug is proven effective.  This drug is proven to be safe.  Instead excuses include narrow failure to connect the drug to a previously abandoned drug of another company and manufacturing issues with non-related drugs at the manufacturing facility.   

The diabetes community overwhelmingly wants this drug to save future diabetes victims.  It is safe, effective, and NEEDS to be available as an option for those at the highest risk of getting Type 1 Diabetes!

The rejection came on the heels of a controversial approval Aduhelm, used to treat Alzheimer's, even after overwhelming FDA Advisory Committee rejection with 1-10 vote to not approve this drug.  Suspiciously, Biden pledged to find a cure for Alzheimer's in his victory speech and Interim FDA Commissioner, Janet Woodcock, was picked by Biden to head the agency.  Three Doctors on the advisory panel resigned because of this corruption.  

The system is corrupt.  FDA should be a means to cure diseases, not a political lever.  Change is needed now!