OSL20190329.pdfDear all – Oncosil has announced a major setback...

OSL20190329.pdf
Dear all – Oncosil has announced a major setback with respect to its CE Mark application. A Clinical Oversight Committee has determined that “at this time, insufficient clinical benefit has been demonstrated to recommend approval”. This advice is contrary to our expectation – we were at BUY on Oncosil leading in to this decision – our view was and is that OncoSil’s PanCO data package is sufficient to warrant a positive CE recommendation.At this stage, the adverse advice does not constitute a formal rejection or refusal to approve. Oncosil believes it can overturn this opinion with further negotiation with the British Standards Institute (BSI).Oncosil’s plans for a pivotal, randomised clinical trial in the USA are unchanged. View on the stock: This is a significant setback in terms of supporting early commercialisation in Europe. Most importantly, our assessment is that this decision has no bearing on Oncosil’s plans in the USA – on which more than 90% of our valuation is based. The OncoSilTM device remains in good standing with FDA, who recently supported its safety data package and encouraged the company to submit plans for a registration-directed clinical trial. Oncosil’s cash balance at end-Dec was $13m which is sufficient to regroup and move forward with its USA development plans. Any and all questions – please call. RgdsSS SHANE STOREY | Equity ResearchP. +61 7 3212 1351 | M. +61 428 509 553Level 30 Waterfront Place, 1 Eagle StreetBrisbane, QLD, 4000