Spoke with someone from investor relations at NVIV today.
Just an FYI - there are warrants in the way of the company up-listing. Once the share price reaches $2.80 (I don't remember the exact number but its around here) for 20 days, they can pull the warrants which will put the company in much better shape to uplist.
Verified that FDA review of cGMP facilities and proof that scaffolds can be created under cGMP conditions stands in the way of approval. No additional pre-clinicals required.