Biotech Values

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Under what circumstances can a company make public a letter from the FDA?

>>MENLO PARK, Calif., May 14, 2008 – Geron Corporation (Nasdaq: GERN) announced today that the company received verbal notice today from the FDA that the company's Investigational New Drug (IND) submission for GRNOPC1, a cell therapy for spinal cord injury, has been placed on clinical hold. A clinical hold is an order that the FDA issues to a sponsor to delay a proposed trial or to suspend an ongoing investigation.

"We have not yet received a letter from the FDA explaining the decision to place the submission on hold, so we are unable to comment specifically," said Thomas Okarma, Ph.D., M.D., Geron’s president and chief executive officer. "Once we have the letter and have had a discussion with the agency, we will communicate our findings and our thinking to shareholders. <<

http://www.geron.com/media/pressview.aspx?id=840

That PR came out some 6 weeks ago. Geron received the letter, but has apparently not shared any of its contents with the public.

Does Geron have the right to release the letter to the public if they want to? Apparently Geron is now claiming the FDA wants to keep discussions relating to the IND private. Certainly possible, given the subject matter. But I am suspicious. Is it more likely that the letter is too embarrassing to the company to be released??

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