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Re: Ryoko post# 11840

Thursday, 09/16/2010 9:18:07 AM

Thursday, September 16, 2010 9:18:07 AM

Post# of 330599
It sure does make you wonder! Someone had stated in a post several weeks ago that a company is required to notify the public within a short time period in the event of actual FDA approval. Does anyone know if there are similar requirements to notify to the public of FDA response on progress on the de nova process? If not, that could explain Andy's recent comments regarding his high confidence level for FDA approval very soon. I know there are several of you that are very knowledgable on the FDA approval process so any insight would be great to hear.