Ayala Pharmaceuticals Inc (ADXS)

[Meishairwin]

Ph2 GOG-0265...just as a reminder, this study showed good, if not overwhelmingly good, results (38% 12 month OS vs 30% for SOC; p <0.02).
The sample size was fairly small so the findings are not overwhelmingly positive (38% vs 30%) or robust (<0.02 on N=50). Keep in mind, this was not a 2-arm randomized study (typically required for Ph3). Therefore, I think an accelerated FDA approval application for AXAL is not likely and the company has not said it will do that as far as I know.

The registrational study for AXAL will be AIM2Cerv, which is beginning now, but will not have a read-out until 2020 (per company statement). Therefore, FDA approval would not come until until after that point.

http://www.advaxis.com/wp-content/uploads/2017/03/Advaxis_SGO2017.pdf

While I'm hopeful of EU marketing approval, it could be early/ mid-2018 before that occurs, with revenue not to be expected sooner than ~12 months after approval (~2019).

DOC is pushing hard and fast on all fronts, so delays due to mismanagement are unlikely, there are other parties that ADXS must rely on for approval and marketing that may not have the same break-neck urgency.

Other combination trials are in progress but are Ph1/2 and not likely to lead to FDA approval before the above. ADXS's exciting neoantigen work with Amgen looks very encouraging, but it also is in very early days.

Anyone expecting ADXS to vault to a $6B valuation anytime soon (e.g., 1-2 years) is fooling themselves, IMHO. Could ADXS get bought out in the next 1-2 years at a very nice multiple of its current value (e.g.,10X; $3B; $50-$75/sh)? Sure, could happen.

I'm as serious about my investment in ADXS as anyone on this board, but the rampant "why doesn't ADXS get FDA approve AXAL now" talk is naive and unrealistic, and the "Dan is messing up our investment" talk is just as misguided. Both are not well-considered judgments, IMHO.

Take time to absorb what this excellent presentation by DOC posted by txfarmer provides:

www.youtube.com/watch?v=_1uS6V5WtO4

ADXS is making EXCELLENT progress -- it's just a slow slog to a much higher valuation. Pay attention to the fundamentals, buy dips (as we have had recently), watch out for any data that suggests Lm is not as robust as we believe (although the Amgen partnership dispels much of that concern for the time being), and, finally, be patient, hard as that is. I understand those who invested in 2013 or before are frustrated, but it's the future you need to evaluate, not the past.