US Stem Cell Inc (USRM)

[sdave2002]

Quote, LOL, and HOLY COW! and GINORMOUS! USSC RESPONSE TO THE BIG BAD FDA! http://usstemcellclinic.com/fda-response/

FDA needs to answer the questions!

Notwithstanding the above—and again, in an abundance of caution—it is our sincerest interest to adhere to the FDA’s interpretation of the laws and have several specific questions that we would like the FDA to kindly provide answers to:

1. Why would bone marrow in-clinic procedures be regulated differently than fat and/or stromal vascular fraction?
2. Is fat which has been mechanically broken down (i.e. the LipoGems procedure) instead of enzyme digestion regulated differently?
3. Will you allow clinics who are using bone marrow to continue to treat patients?
4. Will you restrict the type of patients who are being treated using in-clinic protocols with bone marrow?
5. Will you restrict the discretion of physicians on patient selection to treat using their own body tissue?
6. Are you intending to limit surgical procedures which have been in practice for decades that involve more than minimal manipulation?
7. Are you intending to limit surgical procedures which have been in practice for decades that involve non-homologous use?
8. Are clinics using fat tissue but not using enzyme permitted to operate?
9. Why is the FDA viewing a patient’s own body tissue used in clinic as a drug – please show specific case law justifying this violation of human rights?
10. Why has the FDA visited similar clinics and not taken action?
11. Why is the FDA ignoring the requests of tens of thousands of citizens to keep these therapies available?
12. After the FDA hearing in September 2016 where scientists, physicians and patients spoke out in favor of these therapies, why has the FDA not responded?

Legit questions!

HD you are my hero! LOL