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cvinvestor

03/31/15 12:22 PM

#11964 RE: lab40 #11962

Why would you say human trials are a year or more away when the HemaXellerate IND was approved except for GLP safety trials. If new safety trials have same or better results than before, HemaXellerate will be approved for human trials within 30 days of the safety data being submitted to FDA since they have already approved manufacturing and human trial protocol aspects of IND.

So I believe we get green light from FDA to go to human trials within 4-6 months. And if I recall correctly they already have a doctor and hospital designated to conduct the human trials for HemaX.