Pillar 2 - Breast Cancer, page-86

Off the top of my head I think these are the main reasons any clinical trial can fail:

1. inadequate planning
   • focusing on the wrong indications ( could impact recruitment due the competition for patients )
   • getting patient selection criteria wrong
   • getting drug dosing protocol wrong
   • selecting the wrong primary and secondary endpoints
   • selecting the wrong people to run the trial
   • selecting the wrong trial sites ( could impact recruitment )
   • not taking enough care with paperwork necessary to commence a trial
   • failing to recruit patients in an acceptable timeframe ( related to factors above )
2. drug not safe
3. drug not effective

We know from the history Bisantrene is safe and effective. It’s actually quite hard to find compounds that go the distance to become an approved drug ( and Bisantrene was approved in France for AML ).

There are many, many factors outside the safety and effectiveness of a drug that could cause a trial to fail.

RACE are unlikely to be the ones seeking approval. RACE’s focus is on getting the preparation right such that a potential buyer will be confident approval is achievable  based on preclinical data and/or readout data from trials.