Ayala Pharmaceuticals Inc (ADXS)

[hovacre]

I think it's positive. If they can identify definitive biomarkers of long-term disease control, then they will have a huge "in" with the FDA, even if their drug only works in something like 10% of patients.

Unfortunately, a biomarker of treatment failure is a little less enticing, as it doesn't tell you who should not have receive the treatment in the first place.

There's also the interesting implication: ADXS-PSA clearly does generate a strong enough pool of patients with disease control to study, which is a favorable sign. Note that Provenge was approved based on 4-month improved overall survival, and it did not impact time to treatment failure. PROSTVAC improved OS by 8.5 months, and it failed to improve progression-free survival.

So this is not negative news, and I look forward to the full report!