Christiaan, how did Tercica get around emea procedures? How did they get MAA for an orphan drug validated five months before receiving orphan designation? Are they the only ones who do not have to follow procedure or does the emea just arbitrarily decide who has to follow procedure? While I do not claim to be an authority on this process, I have checked several drugs and they all follow a procedure published by emea. While the MAA is submitted prior to orphan designation, if memory serves, 3 or 6 months prior, the clock does not start until validation is received, not when MAA is submitted. Since the links to this process have been posted on this board and discussed, can you post a link that supports a different process that would enable Tercica to abort this procedure? Tercica has a history of playing with words and I can see them submitting the MAA and the emea receiving it in Jan. 06 and Tercica saying it was accepted in Jan. 06. Kind of depends on what your definition of is, is.
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