Galena Biopharma fka GALE

[MDMSCF]

The difficulty in estimating when 70 events will occur for the PRESENT trial is in what info is available to us in regards to actual enrollment numbers over time since the start of the study. The only information I can confirm are the following; 535 enrolled September 2014 and 758 enrolled April 2015. Given this I built the model making my own assumptions on how many patients were enrolled for each group each month since the start of the study. A key metric to the accuracy (or lack thereof) of my model is my assumption that at least 400 patients were enrolled on or before 1/1/2014. If this is the case and NeuVax is demonstrating a DFS less than 30% then 70 events should have occurred already. A 50-75% DFS for the NeuVax group would put 70 events between 09/2015 and 04/2016.
Disclaimer: this model is nothing more than my estimates and depends on a lot of unknowns including % of each group enrolled when, historical recurrence rates being maintained, drop-out rates, etc.