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Re: None

Tuesday, 04/20/2010 1:27:54 PM

Tuesday, April 20, 2010 1:27:54 PM

Post# of 92948
FDA and NIH,

The FDA removal of clinical hold has nothing to do with the NIH approval of cell lines. The NIH approval means cell lines are eligible for Fed funding.

If the FDA were to remove clinical hold, ACTC could proceed with MN09 line using private funding if NIH did not approve cell lines.

Some confusion may come from this statement. If ACTC still plans on FFB and DoD in trials then the cell lines MUST be approved by NIH, according to Lanza.

"As a private company, Advanced Cell itself is not bound by N.I.H. rules, but its clinical trial, to be conducted with the Foundation Fighting Blindness, will be supported by the Department of Defense, so the institutes’ approval of the cells is required, Dr. Lanza said."
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