The one thing that worries me a bit is the China FDA approval status. The verbiage has changed in the latest 10-Q (removing the "if"), but earlier Q's state the following:
"In September 2005, the Company entered into a licensing agreement with Shanghai Ya Jun Medical ("Shanghai") for the sale of Uracyst in China. All product specifications have been approved by the Chinese regulatory body (State Food and Drug Administration "SFDA") and the final document submission was delivered to the SFDA in June 2007. Although the Company anticipated this registration would have occurred in 2007, to-date such approval has not been granted. The Company has been in discussions with an associate of Shanghai in regards to regulatory documents that have been requested by the SFDA. At this time it is uncertain as to if or when approval will be received from the SFDA."
I just sent an e-mail to the Company, and I'd like to learn a little more about the hurdles they face with China State FDA approval since they filed for approval back in June 2007. I'd think that the recent Uracyst patent issued by China would portend the product getting approved, but I just can't find much discussion on the topic in my research...
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