Unfortunately, ADXS’ guidance for when the first NEO patient will be dosed has been pushed back to IH18,* according to the 9/11/17 PR.
Thus, 12-15 months will elapse from the time ADXS got FDA approval of the NEO IND in Mar 2017 (#msg-129238272) until the first patient in the phase-1 trial is dosed. Such a long delay can only mean one thing: ADXS does not yet have the NEO manufacturing squared away.
This is a pretty big setback and is probably the main impetus for the sharp decline in the share price since the 9/11/17 PR, IMO.
*In practice, “1H18” almost always means 2Q18; else the guidance would be given as “1Q18.”