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Oncosil Medical Limited (ASX:OSL)

ALERT: Price-sensitive ASX Announcement for OSL
Current share price for OSL : $1.505 1.07 (245.98%)+
Announcement
Release
9 Jun 2026 9:48AM
Price at Release
$0.435
Full Release
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Summary
OncoSil Medical Limited announced that the U.S. FDA has confirmed all outstanding questions related to the Humanitarian Device Exemption (HDE) application for the OncoSil™ device, which is targeted at treating distal cholangiocarcinoma (dCCA). The application has progressed to the final review stage, with only the submission of final device labelling and updates to the proposed post-market study remaining. OncoSil expects to submit the required information within 30 days, after which the FDA intends to complete its review within 45 days to potentially grant the HDE. This advancement marks a significant milestone for OncoSil's U.S. regulatory efforts.
Key Points
  • FDA confirms all outstanding questions related to OncoSil's HDE application have been addressed.
  • HDE application advances to final FDA review stage for potential approval.
  • Only final device labelling and post-market study updates requested by FDA.
  • FDA intends to complete review within 45 days of final submission.
  • Significant milestone for OncoSil's U.S. regulatory program.
  • OncoSil's CEO, Nigel Lange, emphasized the importance of the FDA's confirmation.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should refer to the full announcement here for further information.