Hah! The FDA, in its great and infinite wisdom said “now wait a minute” to Geron Corporation. Here’s the scoop in its entirety.
The company, based in Menlo Park, Calif., had planned to begin a human trial soon to test its stem cell compound in patients with spinal cord injuries.
The company received oral notice about the delay from the Food and Drug Administration on Wednesday and is awaiting a letter from the agency explaining its decision, said Geron’s chief executive, Thomas B. Okarma.
Ren Benjamin, an analyst with Rodman & Renshaw, said the F.D.A. action was not surprising and was likely to delay rather than stop the trial.
While companies typically do not announce when they submit an application to begin a trial for an investigational new drug, the F.D.A.’s action means Geron must have submitted its application in the last 30 days, Mr. Benjamin said.
The F.D.A. convened a meeting April 10 of expert advisers who stressed the need for stringent safety measures in embryonic stem cell trials.
Steven Bauer, chief of the F.D.A.’s cell and tissue therapy branch, said at the meeting that the agency might require “particularly strong” evidence early in studies that stem cell treatments are effective. The agency may also require longer trials of stem cell therapies than it does for conventional drugs, Mercedes Serabian, a supervisory toxicologist for the agency, said after the meeting.
The company will announce its plans once it receives the F.D.A. letter, Mr. Okarma said. “We are disappointed with this action given the interactions we had with the F.D.A. over four years leading to the filing” of the company’s 21,000-page application for the trial, he said.
- Jennifer Lahl, MA, BSN, RN, is founder and president of The Center for Bioethics and Culture Network. Lahl couples her 25 years of experience as a pediatric critical care nurse, a hospital administrator, and a senior-level nursing manager with a deep passion to speak for those who have no voice. Lahl’s writings have appeared in various publications including Cambridge University Press, the San Francisco Chronicle, the Dallas Morning News, and the American Journal of Bioethics. As a field expert, she is routinely interviewed on radio and television including ABC, CBS, PBS, and NPR. She is also called upon to speak alongside lawmakers and members of the scientific community, even being invited to speak to members of the European Parliament in Brussels to address issues of egg trafficking; she has three times addressed the United Nations during the Commission on the Status of Women on egg and womb trafficking.