BioAgra's website now states that Agrastim® has been declared "Generally Regarded As Safe" by the FDA. This designation has significant implications. I am looking for a public statement from the company with more details. For more on GRAS, here is a link. http://www.cfsan.fda.gov/~dms/grasguid.html My Congratulations to all at BioAgra and, of course, to VYTA Corp and its shareholders! This is an exciting milestone. -zties