I thought the now proper explanation around Distal Cholangiocarcinom (bile duct cancer) HDA application for FDA approval is a big tick for me. It is just that Nigel Lange was not at all convincing when asked some questions about it during the last investor update. But he was very new to the role at the time. Back to a speculative buy for me.....IMO.
"On 28 July 2020, OncoSil announced that it had filed a Humanitarian Device Exemption (HDE) application with the US Food and Drug Administration (FDA) for its OncoSilTM device in the treatment of distal cholangiocarcinoma (bile duct cancer).The HDE is focussed on mass-forming distal cholangiocarcinoma (dCCA), which is a solid tumour similar in form to pancreatic tumours that develop from the common bile duct within the pancreas. A dCCA mass can be treated using the same endoscopic-guided approach as locally advanced pancreatic cancer (LAPC) and the FDA have agreed that the safety data from the PanCO study in patients with unresectable LAPC are an appropriate surrogate for the treatment of the dCCA using the OncoSilTM device."
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