PharmaCyte Biotech Inc (PMCB)

[Peacefulwendy]

It is really difficult to answer that question unless you have experience with GMP compliance.

However, here are a few of my thoughts. This is Austrianova's first time building their own GMP facility. Whenever a venture is in new territory, lessons have to be learned. We may have needed equipment or other things that were not anticipated. Additional costs may slow things down. Also, when we originally anticipated having GMP approval by the end of 2014, we were not working with a U.S. entity. Once we started working with Dr Von Hoff, the FDA got involved. Seeing that the facility is in Thailand, there may be additional steps to getting approval through all agencies. There may be other possible reasons that I missed and I am hardly an expert. :)

However, the good news is, we are still on track for trials to begin at the end of 3q so it does not appear that we believe we are in jeapordy of not getting approval.