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() is poised to receive a tax refund of about $6.74 million after receiving approval from AusIndustry for its overseas research and development expenditure.
This confirms that it is conducting eligible research and development and certain activities of its research and development program must be conducted overseas.
The finding certifies that all eligible expenditure incurred in relation to OncoSil’s development project will be subject to a tax refund. The refundable tax offset is currently set at 43.5 % of eligible expenditure.
“This was a thorough detailed review of our project and we are very pleased with this finding” executive chairman Roger Aston said.
“We would like to thank AusIndustry for the professionalism with which it was conducted. Their finding is important because it gives validation to our processes and the manner in which our project is being conducted.
“It also gives an increased level of certainty to our internal cash flow projections as the approval is binding.
“The confidence that we will receive these tax refunds each year allows us to continue to focus on our primary objectives.”
OncoSil™
The company continues to advance the clinical development pathway for the OncoSil™ device as a new and commercially available option for the treatment of pancreatic cancer and then marketing the product on a global basis.
It recently commenced a Pivotal Trial that will enrol 150 patients across 20 trial sites.
This will compare patients receiving standard-of-care (for inoperable pancreatic cancer this includes chemotherapy treatment) with patients receiving standard-of-care plus OncoSil treatment in a randomised and controlled fashion.
The Australian trial is expected to take 12-18 months to evaluate patients and determine their progress.
A key goal of the trial is also to have results published in a prestigious medical journal with a view to influencing the standard-of-care (the current accepted best practice treatment) provided to pancreatic cancer patients globally.
Positive data generated by the Trial may facilitate the commercialisation of OncoSil including in the US which is the world's largest health care market.
The main focus of the Pivotal Trial is for FDA approval and for the results to be published in a prestigious medical journal. The Johns Hopkins University in Baltimore under Professor Joseph Herman is planned for the role of lead investigator.
OncoSil plans to roll-out the trial in Australia in parallel with trial sites in the UK Belgium US and then Singapore. Engaging hospitals as trial sites is a key initial focus followed by patient recruitment and then the commencement of dosing patients under the trial.
It also continued to make preparations for an Investigational Device Exemption application (IDE) submission for OncoSil to the US Food and Drug Administration (FDA) and expects to submit an IDE in the near future.
An IDE submission would represent a significant step in the regulatory pathway for OncoSil and is the first step towards securing the FDA's commercial approval for OncoSil under a Premarket Approval (PMA).
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