Ayala Pharmaceuticals Inc (ADXS)

[ubmmg]

Something is not right about Aim2Cerv enrollment.
August '17 presentation: 2018/Q4 -- last patient enrolled, 2H/2020 -- study completed;
March '18 presentation: Data expected 2020/2021;
From clinicaltrials.gov: Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2021;
Primary Outcome Measures :
Disease free survival (DFS) [ Time Frame: 5 Years ]
Secondary Outcome Measures :
Safety & tolerability Overall survival (OS) [ Time Frame: 5 Years ]

From today's PR: "“The redesign of AIM2CERV with an earlier interim analysis would allow us to alter course or, if necessary, stop the study, depending on the results. If the FDA accepts our proposed revisions, we anticipate having a recommendation based on the interim analysis from the data monitoring committee as early as the fourth quarter of 2020.”

So, what exactly do they want FDA to change? Enrollment should have been completed pretty much by this time. Slow enrollment? Do they want to reduce the time frames from 5 years down to 2 or 3 years? First patient was enrolled in Q1/2017. Time frame for 3 years would make sense for interim readout if they enrolled 100-150 patients in 2017. Hov, please chime in.