US Stem Cell Inc (USRM)

[Dragon Lady]

Trials abroad- real interesting read. I was still wondering, if you do a trial outside the U.S., does the FDA "recognize" it as "enough" to allow you to submit for approval here. I decided to google some terms like, "off shore medical trials" or "trails outside U.S." and got a bunch of good articles. The following one I think is the best- the guy writing lists his resume at the end- and he knows what he's doing. He points out at the end of the very long article, that even though you've done a trial outside the U.S. and gained approval from that country's regulatory body- you still will need a U.S. based trial for our FDA to grant you approval, ultimately- that's my take/read on his conclusions. Which is an eye opener for me. As it means the off-shore stuff is just step-1, as in "trying" to open a marketplace, but if you want the granddaddy big "approval", meaning FDA, you still have to come back here and do it here inside our borders and get our FDA approval based on that data:

http://www.mddionline.com/article/study-abroad-tips-successful-clinical-trials-outside-united-states

"Effectively Positioning Technology for U.S. and European Trials

While the U.S. Food and Drug Administration (FDA) and the European Union (EU) ultimately require data on patients within their borders before issuing FDA clearance or a CE mark respectively, a trial conducted abroad in a credible manner can give a company a running start to securing regulatory approvals these markets."

Several articles under those google search terms, also seemed to strongly indicate that registering the trial on the .gov web site is still the standard practice and norm, even when it's being done outside the U.S..

http://www.janssenrnd.com/our-innovation/clinical-trails

http://www.nytimes.com/2009/02/19/business/19clinic.html?_r=0

http://www.esternmedical.com/information/article21.php

http://www.ncbi.nlm.nih.gov/books/NBK50886/ (very interesting below- it says committee to be published in a major medical journal, more or less mandated trial be "registered" on .gov site)
Clinicaltrials.gov

The Food and Drug Administration Modernization Act (FDAMA) of 1997 mandated the creation of the clinicaltrials.gov registry for efficacy trials in serious and life-threatening conditions and interventions regulated by the FDA. Developed by NIH’s National Library of Medicine (NLM) in 2000, it allows interested parties to find information on both completed and ongoing clinical trials. The database includes federally and privately supported clinical trials, and study sponsors are responsible for submitting timely and accurate information about their studies.

The database registered a modest number of clinical trials in its initial years (Figure 2-1). A dramatic increase in trial registration came in 2005 in response to the newly introduced International Committee of Medical Journal Editors’ (ICMJE’s) requirement that studies published in their journals be registered in clinicaltrials.gov or other equivalent publicly available registries. The Food and Drug Administration Amendments Act (FDAAA) of 2007 created a legal requirement for the registration of trials of drugs, biologics, and devices, generating a modest increase in the registration of trials over what had been seen in 2005. Given the increasing number of trials registered on clinicaltrials.gov over time, the database encompasses a broad spectrum of research organized by study sponsor (industry, government, and nonprofit), disease and treatment being studied, and trial design.

Lastly was this one- a REAL LONG READ, but interesting, in that it said that indeed, there has been "some" as in a limited number of new drug candidate/devices approved now by the FDA where the entire patient set and trials were done totally outside the U.S., though it appears it's still not accepted or preferred as the "norm" and certain countries seem to carry more weight than others- most notably W. European, as of course their standards and methods would be most closely aligned with U.S. practices. As you can see if you choose to read it- this FDA approval stuff is daunting to say the least, as in mega-complex and daunting. I can see why it takes a big staff normally, and real experts with mega-FDA-regulatory experience to navigate the gauntlet. It's real complex stuff/laws.

https://www.law.upenn.edu/live/files/2257-wilson34upajintll6412013pdf

Interesting- we'll see I guess.