The question the regulatory authorities are going to ask is 'where is the data?' Efficacy? Safety? This company will never be worth anything much until it has done adequate trials to demonstrate that it works and is safe. To do such trials cost many millions, and will take years. Breakthrough designation? You are deluded if you think this is likely at any time in the foreseeable future.
The likelihood that intramural injection of brachytherapy by EUS will have a dramatic effect on survival I think is low - the tumour infiltrates through tissues in all directions, and metastasises, quite unlike the typical spherical mass-like growth of liver tumours. Death in pancreatic cancer is generally caused by thrombotic complications or immune suppressive effects of cachexia, a systemic effect, as opposed to single organ failure in hepatoma. Adequately targeting the relevant tumoral tissue in pancreatic cancer would be extremely difficult in most patients, unlike the very straight forward targeting in hepatoma. These tumours are not at all comparable, and to assume that a modality that works in one would have benefit in the other is naive.
OSL Price at posting:
22.5¢ Sentiment: Sell Disclosure: Not Held