FDA Dialogue Over Solution to MRSA
Concerns and Supplementary Data To Informed Consent Document
FDA vs. emea.europa.eu The University of Quantum Dynamics is a duly registered Health Research Facility under the European Commission Directives; Participation in the Health Research Financing Framework Seven, [FP7], PIC# 997892060 The Commissions’ Health Director has stated multiple times that the US FDA is arbitrary and capricious in relation to their rulings on Investigational New Drug applications, and will do everything in their power to obscure the facts and tarnish the reputation of anyone or any research institution to protect the major pharmaceutical houses, rather than the public. And unless and until the government of the United States prohibits the FDA employees from working for the pharmaceutical houses in any capacity while they are employees, before they become employees or after that have left the FDA, this type of activity will continue to occur and such abuse of authority and deceit as a form of corruption is intolerable, thus understandable that US Health Research Institutions would seek to participate in EU Programs.
The following is a tit for tat tally of the FDA – EU discussions: Pursuant to 21 CFR 50.25 requirement for the Informed Consent Document is not of itself faulted, the 21 CFR 312(a)(11) can be faulted depending on the additional requirements stipulated by the FDA, but no such letter has been issued in this case.
FDA Claim: Unusual Toxicity.
EU Findings: Non-Toxic with exceptions of people sensitive to Silver-organometallic compounds [People with Argyles Syndrome] less that 1- 100th percentile of the global population and less than 20 people in the US and Canada (Reported Cases). The EPA findings are erroneous concerning Copper Toxicity in Humans and Animals: if 2ppm was toxic, and 20 ppm was lethal, there would be no life on earth, as all life depends on copper balance with iron, or about .9% of body weight, far over the 20ppm lethal level they claim.
FDA Claim: Study Population is particularly vulnerable.
EU Findings: We have travelled throughout America and Canada, and except for the people in government do not find that a large percentage of Americans and Canadians are intellectually challenged.
FDA Claim: The study design is unusual for the therapeutic class.
EU Findings: The FDA is delusional in this response as they have no class for tissue regeneration and regenerative medicine in any form as it is a new science.
FDA Claims: CDER at FDA is in a better position the IRB to access whether the ICD adequately addresses a particular concern based on proprietary data.
EU Findings: Patent No. 12001344 has been published, thus there exists no proprietary data, the CDER concerns are to protect the major US pharmaceutical houses against this new innovation that would assuredly result in a curtailment of their triple digit profits on dangerous drugs.
Additional EU Findings: The IND protocols submitted to the EU under the US Regulations 21 CFR 312.34 and 21 CFR 312.35 exceed our standards for safety and efficacy from the University of Quantum Dynamics College of Medicine. UQD has EU FP7 Health Partnerships in Algeria, Argentina, Belarus, Chile, Eqypt, Faroe Islands (Denmark), Jamaica, Mexico, New Zealand, Russian Federation, South Africa, South Korea, Thailand, Uganda and Uraguay, as well as the entire European Union. (Specifics available upon written request with proper credentials only).