US Stem Cell Inc (USRM)

[Dragon Lady]

Just posted some links (long reads) along the same lines. The journal publishing part seems pretty clear-cut from a couple of the articles- as in the committee of editors "mandated" it, a while back.

Two of the links though were in conflict- as in one saying you still need U.S. based data ultimately for full FDA approval here. The other one stating there has been "limited", as in some drugs/devices approved now where all data was done outside U.S..

Interesting to say the least- but complex as heck, that much is for certain. I knew that already- dealing with the FDA is 2nd in complexity bar none. I don't even think the FAA or IRA is more complex, difficult to navigate. That's why there are people in FDA approval/regulatory positions, "hired guns" who make entire 20 or 30 plus yr careers out of doing noting but working for company's or as contractors or for contract firms in FDA interface and navigating the approval process- people with maybe a engineering or bio-science background, then maybe a MBA or law degree and maybe even another advanced degree or two tacked on- maybe even an M.D. or Ph.D. also. It's complex stuff to say the least. I've seen the info cited before - that a phase III, final FDA submission for approval can run THOUSANDS pages long, just a staggering undertaking, and then reviews and approval can drag on for year(s) often.

http://www.forbes.com/sites/theapothecary/2012/04/25/how-the-fda-stifles-new-cures-part-ii-90-of-clinical-trial-costs-are-incurred-in-phase-iii/

http://www.fiercebiotech.com/topics/fda_approval_process.asp
Of 5000 compounds discovered in the pre-clinical stage, only about 5 will make it through the entire FDA approval process. (WOW !)

New Drug Application (NDA)/ Biologics License Application (BLA)

If the drug proves to be safe and effective, the company then files an NDA or BLA with the FDA. NDAs and BLAs are typically 100,000 pages long and include results of human and animal trials as well as information on how the drug is manufactured. It usually takes the FDA 1-2 years to complete the review process and approve a drug. However, there are cases when approval can be accelerated.

(100 THOUSAND pages of documents, again, WOW !!)