$4 Million Clinical Trial Savings

FDA had required 18 months of telephonic safety follow-up for a phase 2 program based on a specific concern.  Dr. Gorelick became aware of a recent publication from FDA that indicated the safety risk was no longer present after 4 months. Based on this publication, we amended the protocol to eliminate the 18-month follow-up and communicated this to the Division to assure that they would accept the amendment. It was accepted, and this resulted in a $4 million saving for the client.