Biggest issue in my opinion was withdrawal from TGA application and that decision was made under Nigel leadership..."
I wasn’t a shareholder back then, but looking at it now, under Nigel’s leadership OncoSil pivoted strategically — and helped preserve scarce resources.Australia’s market is small. Rather than wasting scarce resources trying to force an outdated CE submission through TGA (which could have triggered audits and delays), they pivoted to pursue full MDR approval — a much stronger global credential.
TGA later confirmed:
Applications supported by MDR certification will generally have a smoother review pathway compared to MDD/CE-based approvals.” 【TGA guidance 2021–2022】
MDR was achieved in January 2025. TGA resubmission based on the MDR dossier is now planned.
"After withdrawal too much money spent on US trials and data compilation and till date no result for HDE application either!!"
Fair point that the HDE process has taken longer than hoped (although I believe we're just about there!).
However, just to clarify — OncoSil did not run a new clinical trial for the HDE submission.They leveraged existing PanCO study data and supplemented it with standard regulatory responses to the FDA — not runaway trial spending.It’s frustratingly slow, but the commercial opportunity remains valuable if successful, as seen with Boston Scientific’s TheraSphere™, which operated under HDE for over 20 years and helped build ~$85M/year in sales.
"Today you have no patent... bigger player wanted product with longer patent duration."True, the original patent expired in 2022.However, OncoSil holds an exclusive global licence that remains valid until at least 10 years after first commercial sale — meaning protection extends into the early 2030s across Europe.More importantly, real-world barriers like radioactive device manufacturing, regulatory compliance, hospital onboarding, and surgeon trust make copying the platform extremely difficult — not just a simple matter of patents.I’ve broken this down in more detail in my thread “OncoSil Patent Expiry – Real Threat or Overstated Concern?”
"They could have stopped everything after TGA response and gave licence back to the US company."To be clear — the licensor is pSiMedica, a UK-based company, not US.They’re no longer involved — OncoSil owns full global commercialisation rights and carries all the risk and upside.
(20min delay)