Provention Bio, Inc. (PRVB)

[sokol]

Provention Bio Appoints Jan Hillson, M.D., as Senior Vice President of Clinical Development - See announcement above. Clinical development includes the entire process of bringing a new drug to market. As best I can determine, the company has met most of the FDA’s concerns regarding teplizumab; however, it also needs to address the comparability of the drug being manufactured for commercial use and the product used in previous clinical trials. Provention, I think, plans to meet with the FDA in December about designing a study to resolve this issue. I feel confident this issue will be addressed to the FDA’s satisfaction, and the drug will eventually be approved. However, this last issue may take some time that takes us into the first quarter of 2022 before we definitely know for certain that all hurdles have been met.