Hoosier, I agree 100 percent with you. There has been alot of FUD on this issue, and I wanted to show FDA standards and how our situation fits in line with those standards. Some people have been saying that because we only have toxicology date our ODD status is going to be a extremely difficult goal to obtain. That is not true because as you pointed out we have a human born molecule, not an artificial drug that has non human elements. Thus, because of the MANF biological profile, coupled with the white paper, and toxicology studies, our ODD status will be kosher with no bumps in the road. After reading through all the posts on this issue, I wanted to provide some clarification on our strength in regards to the FDA requirements.

All the best.