FDA Breakthrough Therapy Designation - What is Geron Waiting For?
Hoyoung Huh, M.D., Ph.D.
Chairman of the Board
149 Commonwealth Drive
Menlo Park, CA 94025
Dear Dr. Huh:
As a long time shareholder, I would like to bring your attention the enclosed FDA Breakthrough Therapy Designation (enclosed). If Geron has not already applied for this, I strongly encourage the company to do so at this time. Novartis has Phase I results that are not even as good as Geron’s, and has been awarded breakthrough status (see enclosed).
Successful application by Geron to this program might enhance shareholder value, which currently leaves something to be desired. There is no reason why Geron cannot apply for the FDA program immediately, and I believe it falls within your fiduciary duty to make this a priority.
I was very concerned about the recent comments that the company intends to “wait” for the Mayo Clinic results. Application to the FDA program would not impact the Mayo study, but could accelerate the entire approval process.
Patients and shareholders should not have to “wait” if it can be avoided.