Not ethical? Say again?
The Company’s decision to proceed with the UK clinical trial was made after
authorization from both the Medicines and Healthcare Products Regulatory Agency
(MHRA) and an independent Ethics Committee following review of all information
relevant to the safety and potential efficacy of anatabine citrate. The
information reviewed included results from several additional preclinical
toxicology studies conducted after receipt of the FDA’s clinical hold letter in
August 2014. As such, the Company believes that the commencement of clinical
trials in the UK was appropriate and in accordance with all applicable rules and
regulations. The Company believes that it is also of relevance that the FDA
authorized an investigator-initiated IND (as filed by a third party) to test the
Company’s compound in human subjects in 2012.
What I'd like to know is who at the FDA has a problem with this company.