US Stem Cell Inc (USRM)

[Dragon Lady]

Doesn't explain anything. The company, BHRT is located on U.S. soil- so if they are providing any product(s), services, etc that goes into this "treatment" and it's being made here, the profits and money of the 49% ownership return here, etc, then the FDA is involved IMO, as the product is a "drug" or "medical" device and under their regulatory authority.

The article sited is discussing S. African law, which means nothing to a company operating off of U.S. soil.

Pfizer for example, can not make an un-approved drug on U.S. soil- and then simply claim that since they don't market it here, everything is cool, aka we're only selling it in the 3rd world or whatever. Not how it works as far as I'm aware?

If you bring your money back here, aka revenues and profits, if you produce anything here that goes into the process/product/procedure or whatever- then it's "regulated" here as far as our regulatory bodies are concerned.

Else, IMO, you'd have to have a fully "off-shore" subsidiary or similar that fully handles the non U.S. regulated items and insure that no money, profits or anything else is ever repatriated back to the U.S. side, otherwise, you're under our laws and regulations IMO.

Further also, it says Comella "trained" and provided her "expertise" to do these medical procedures (and she's not even a physician)- and then returns back to U.S. soil as her home base of operations. Just watch the 60 minutes piece on questionable stem cell "treatments" and how long the arm of U.S. law is when it comes to physicians, medical "treatments", "cures" etc- done in this country and especially U.S. based people/companies attempting to provide those services off-shore, outside the U.S. borders.

The reach of U.S. regulatory bodies for people operating out of the U.S. or licensed/regulated by U.S. authorities (say an M.D. license, a drug/pharma manufacurer) is far and long- IMO. I can site numerous, numerous cases in the news just recently across all kinds of industries and fields, including drug/med/pharma and case law. Example- oil and gas drilling. You can't blow a rig up, kill people and pollute an ocean in some 3rd world or international body of water and claim "immunity" from U.S. laws and repercussions when you're Chevron-Texaco and operate out of your U.S. headquarters- doesn't work that way.

You don't think the FDA is going to look at this kind of company activity, when BHRT comes to them to submit a product for an approval based on trial results? When said product has already been offered and labeled by said company as a "treatment" and been used on paying, non medical controlled "trial" environment "patients" before the FDA ever granted it an approval?