Can OncoSil Secure Landmark US Market Access as Its FDA Review Nears Completion?
OncoSil Medical Limited (ASX: OSL) has reached a significant regulatory milestone after the US Food and Drug Administration (FDA) confirmed that all outstanding questions relating to the Company’s Humanitarian Device Exemption (HDE) application have been satisfactorily addressed. The application, which seeks approval for the OncoSil™ device in the treatment of distal cholangiocarcinoma (dCCA), has now progressed to the final stage of the FDA review process before a potential approval decision. The FDA has requested only final device labelling and any updates to the proposed post-market study, with the Company expecting to submit the required information within 30 days. Following receipt of the final submission, the FDA has indicated that it intends to complete its review within 45 days. If approved, the HDE would allow OncoSil to commercialise its device in the United States for this indication, representing the most advanced stage achieved by the Company’s US regulatory program and a potentially transformational commercial opportunity.
Customer Notice:
Nextgen Global Services Pty Ltd trading as Kapitales Research (ABN 89 652 632 561) is a Corporate Authorised Representative (CAR No. 1293674) of Enva Australia Pty Ltd (AFSL 424494). The information contained in this website is general information only. Any advice is general advice only. No consideration has been given or will be given to the individual investment objectives, financial situation or needs of any particular person. The decision to invest or trade and the method selected is a personal decision and involves an inherent level of risk, and you must undertake your own investigations and obtain your own advice regarding the suitability of this product for your circumstances. Please be aware that all trading activity is subject to both profit & loss and may not be suitable for you. The past performance of this product is not and should not be taken as an indication of future performance.
Kapitales Research, Level 13, Suite 1A, 465 Victoria Ave, Chatswood, NSW 2067, Australia | 1800 005 780 | info@kapitales.com.au
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Can OncoSil Secure Landmark US Market Access as Its FDA Review Nears Completion?
OncoSil Medical Limited (ASX: OSL) has reached a significant regulatory milestone after the US Food and Drug Administration (FDA) confirmed that all outstanding questions relating to the Company’s Humanitarian Device Exemption (HDE) application have been satisfactorily addressed. The application, which seeks approval for the OncoSil™ device in the treatment of distal cholangiocarcinoma (dCCA), has now progressed to the final stage of the FDA review process before a potential approval decision. The FDA has requested only final device labelling and any updates to the proposed post-market study, with the Company expecting to submit the required information within 30 days. Following receipt of the final submission, the FDA has indicated that it intends to complete its review within 45 days. If approved, the HDE would allow OncoSil to commercialise its device in the United States for this indication, representing the most advanced stage achieved by the Company’s US regulatory program and a potentially transformational commercial opportunity.
Customer Notice:
Nextgen Global Services Pty Ltd trading as Kapitales Research (ABN 89 652 632 561) is a Corporate Authorised Representative (CAR No. 1293674) of Enva Australia Pty Ltd (AFSL 424494). The information contained in this website is general information only. Any advice is general advice only. No consideration has been given or will be given to the individual investment objectives, financial situation or needs of any particular person. The decision to invest or trade and the method selected is a personal decision and involves an inherent level of risk, and you must undertake your own investigations and obtain your own advice regarding the suitability of this product for your circumstances. Please be aware that all trading activity is subject to both profit & loss and may not be suitable for you. The past performance of this product is not and should not be taken as an indication of future performance.
Kapitales Research, Level 13, Suite 1A, 465 Victoria Ave, Chatswood, NSW 2067, Australia | 1800 005 780 | info@kapitales.com.au