Rusty, I think you have been fed a load of horse poo. Having said that, I don't think there was anything else she could feed you.
They have had the toxicology available for internal use for several months. They have had time to finalize protocols and submit data to regulatory bodies on an in-confidence basis. They had pre-IND meetings with the FDA about 2 years ago where what the FDA required was set out. http://www.asx.com.au/asxpdf/20141001/pdf/42slv6zflzgy9s.pdf
IMO any announcements regarding the FDA, Ethics committees etc have all had to wait for the toxicology report to be presented. To announce them prior would be preemptive of the toxicology data presentation. My precedent for saying this is the release of ODD for Cantrixil and Anisina - in both cases the announcement of ODD followed immediately after the presentation of significant conference data.
BTW what are the IFD and SDA?
not happy, page-36
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