Ayala Pharmaceuticals Inc (ADXS)

[hovacre]

Well, if we can take the GOG-240 study as a sort of guidepost (http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)31607-0/fulltext), then the enrollment period could reasonably take around 2.5 to 3 years. GOG-240 enrolled from 2009-2012, and their findings for overall survival were analyzable in 2014.

Therefore, I would not personally expect results before 2019, especially given that the study is blinded. Interim results won't be available until at least when a prespecified number of disease recurrence events take place, and that likely won't be reached until enrollment is complete.

It is possible, of course, for AXAL to give such fantastic and obvious results relatively early that they unblind the study and quit the control arm. But this is not something I would count on, as it happens so rarely.

Of course, my timeline is messed up in comparing to the bevacizumab study, since they assessed overall survival (which could take longer than DFS in AIM2CERV), and they were dealing with metastatic disease, not high-risk locally advanced disease.