Yes, its problematic and any CE approval is likely to be qualified since they would really need to run a properly controlled trial with and without Oncosil's treatment to verify safety and efficacy. Such a trial would need to be run like Sirtex's trials for liver cancer and metastatic colorectal cancer against the standard of care chemotherapy. These included a crossover component for patients not responding to the selected treatment.
As difficult as it is to accept for investors, its the only way to genuinely evaluate the safety and efficacy of the therapy. Its very expensive and takes a long time and it may well be confounded by changes in chemotherapy and different types of pancreatic cancer.
Investors hoping Oncosil will soon become accepted as a major treatment for pancreatic cancer could well be disappointed. Its going to be a very long haul.
OSL Price at posting:
13.5¢ Sentiment: None Disclosure: Not Held
(20min delay)