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What is the actual plan? I believe many investors do not either. I do believe the approval process does depend on what they are trying to get approval for.
I have been doing extensive research and believe Dr. Casey's process would involve removing cells from a patient, growing them in a lab and then reinjection them back into the patient.
I will stand corrected but that sounds like adult stem cell therapy. As such it would be the first ever approved by the FDA and could be huge. So the answer as to what they are actually trying to get approval for is critical! Also the costs could reach the hundreds of millions of dollars!

http://stemcells.nih.gov/info/basics/pages/basics4.aspx


The National Institute of Health has already published guidelines for stem cell research but it appears to be directed more towards embryonic stem cells.

http://stemcells.nih.gov/Pages/Default.aspx

The NIH also has approved 284 stem cell lines for research going back to 2009 so it appears some colleges and companies have a big head start.

http://grants.nih.gov/stem_cells/registry/current.htm

Going even further there are companies/universities that already have approval for Phase I clinical studies. For example Tisch MSRCNY has FDA approval for the use of adult stem cells in MS patients to reverse disability.

https://www.indiegogo.com/projects/tisch-ms-center-s-fda-approved-phase-i-stem-cell-trial-for-multiple-sclerosis