You worry me sometimes RBX....for a smart man you sure are dumb sometimes
"Sydney, 12th September 2016 – Australian oncology-focused biotechnology company Novogen Ltd (ASX: NRT; NASDAQ: NVGN) today announced that it had received confirmation from the United States Food and Drug Administration (FDA) that the Investigational New Drug (IND) application for Cantrixil (TRX-E-002-1) had been successfully opened, and the phase I study of Cantrixil in patients with ovarian cancer may
therefore proceed as planned. Dr James Garner, CEO of Novogen, commented “we are grateful to the FDA for their thorough and comprehensive review of our submission, and we are pleased to
have their approval to move forward with the study. The team is already working alongside Quintiles, our contract research organisation, to make the necessary submissions to human research ethics committees at each of the participating sites, and we continue to anticipate initiation of the phase I study in the fourth quarter of 2016, as previously indicated.” "
"Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will probably want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that legal requirement. The IND is the means through which the sponsor technically obtains this exemption from the FDA."
https://www.fda.gov/drugs/developme...estigationalnewdrugindapplication/default.htm
