Ayala Pharmaceuticals Inc (ADXS)

[hovacre]

No control group at all, as the study was designed specifically to test safety of the approach. The efficacy findings were secondary, and no clinician will take them seriously before validation in a larger cohort of patients.

However, it's worth noting that with this kind of safety profile, if ADXS gets any kind of significant improvement in recurrence-free survival in a larger study, it would likely be a strong contender for wide adoption, as the risk-benefit of the approach would be lopsided.

As it stands, there's no way to tell for sure if these efficacy findings are better than what have been observed in larger, randomized trials of chemoradiation alone.