Ayala Pharmaceuticals Inc (ADXS)

[hovacre]

There are watershed moments for ADXS in my mind that build an irrefutable proof of concept


1) Promising preclinical (cell/animal work) - Passed long ago
2) Entrance into clinical trials - Passed long ago
3) Safety of the approach - Demonstrated feasible, especially as evidenced by GOG-0265 results
4) Signals of efficacy - Observed in GOG-0265 and the India study
5) Pivotal trial results - Not seen, probably won't be seen in the recurrent/persistent metastatic setting due to lack of a suitable control
6) Drug approval anywhere - Not yet achieved
7) Post-marketing studies - This will be the ultimate test of validation


A drug approval puts ADXS in just about the highest tier as far as validation is concerned in my mind, and the sky will be the limit from there. Absolutely an approval would be a slam dunk, if only because the entire APPROACH of listeria-based immunotherapy will be validate. Then, even if Axal ends up not being competitive (because of other emerging strategies), there will be ramped up speculation for all of ADXS's other programs.

It's for this reason that I consider the approval in dogs to be a favorable sign of validation, as well. One of their vaccines is marketed somewhere, providing support for using listeria in this way.

Short answer to your question? Absolutely. We will be a $750 mil company at the least, as a conservative estimate. Speculation post-approval on ADXS-NEO would likely build that evaluation a good bit higher, possibly to the levels of the CAR-T companies. But that'd be highly speculative on my part.

And it's all contingent on getting THIS approval.