Off the top of my head I think these are the main reasons any clinical trial can fail:
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 )
drug not safe
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.
RAC Price at posting:
$4.00 Sentiment: Buy Disclosure: Held
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