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Biotech / Medical : Kosan BioSciences -- KOSN
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From: Icebrg9/28/2005 6:50:56 AM
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Item 8.01. Other Events.

As announced on September 12, 2005, Kosan Biosciences Incorporated ("Kosan") and the Division of Cancer Treatment and Diagnosis at the National Cancer Institute ("NCI") received letters from the U.S. Food and Drug Administration ("FDA") requesting certain amendments to the protocols and patient informed consents for the 17-AAG and DMAG clinical trials being conducted by Kosan and the NCI. Kosan has amended the protocols and informed consents for the 17-AAG and DMAG clinical trials being conducted by Kosan. The NCI has also requested that its clinical sites amend their protocols and informed consents. Kosan believes that the amendments in the trials being conducted by Kosan are generally consistent with the amendments requested by the NCI at its clinical sites. Kosan has provided its amended protocols and informed consents to the FDA, but has not received a response from the FDA. Kosan has also been advised by the NCI that the FDA agreed to the proposed amendments being made in the clinical trials being conducted by the NCI. Patient enrollment in the 17-AAG and DMAG clinical trials is expected to resume once the amendments are implemented by the clinical trial sites. Amendments of this nature are typically implemented within one to three months.
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