Salvage treatments for rapidly fatal conditions are sometimes approved for sale very quickly. The absolute silence from MYRX management about regulatory matters prior to the conference suggested that they were trying to make some kind of deal with FDA--not necessarily a quick approval for salvage use, but the possibility was open. Management talking about clinical trial plans suggests strongly that no critical discussions with FDA are happening now (or planned for very soon). It moves the possible time of first sales back a few months.
To some extent, development of Azixa for first-line use against any cancer at all is a detour. The marketing target is all cancers metastatic to the brain--a mostly third-line situation. Of course it would be nice if Azixa got dropped into standard first-line treatment protocols for cancers with a tendency toward brain metastases, to prevent that development. Messing around with such protocols happens slowly, though, and with nearly as much testing as initial drug approval.