Ayala Pharmaceuticals Inc (ADXS)

[hovacre]

If an interim analysis shows that the DFS endpoint is going to be met, particularly to whatever standard has been set by the SPA, then the company will seek approval based on what they have.

It depends on how well the controls perform, and it depends on how active Axal is in that setting.

Say, for example, that the monitoring board gets a look next year, and 100% of patients in the Axal arm remain disease free, whereas only 80% are in the control arm. This would be compelling, and it will likely get things moving a lot faster.

But the more typical scenario is that you need to wait long enough for the two disease-free survival curves to separate, and I don't have a clue how long that might take. In cases where there's high risk, studies like PACIFIC showed a separation quite early. But in better tumor areas, like the APHINITY study, the curves barely separated, and it took thousands of patients and 3 years of study to see any difference.

In cervical cancer, the situation isn't great, so I expect if Axal is a fantastic drug that we'll know well before 5 years whether it's working.