ADXS’ guidance for when the first NEO phase-1 patient will be dosed has been pushed back to IH18,* according to the 9/11/17 PR (#msg-134547685).
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 mean only one thing: ADXS does not yet have the NEO manufacturing squared away.
This is a pretty big setback and is perhaps the main impetus for the sharp decline in the share price since the 9/11/17 PR.
*In practice, “1H18” almost always means 2Q18; else the guidance would be given as “1Q18.”
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