The share price movement today seems to suggest a bullish tone in the quarterly report..
However I have some reservation regarding the following quotes:
"Due to the complexity of the FDA regulatory pathway required for the Company’s combination (device/drug) suite of products including its future software as a medical device (SaMD)..................
The Company continues to work with the FDA on the suitability of its topical fluorescein approach for oral tissue imaging following feedback received from the Agency late in 2023. Given the requirement for a contrast agent for successful deployment of the Optiscan devices, coupled with the new regulatorychanges around contrast agents being classified as drugs, and the feedback and advice received from the FDA, the Company has commenceddiscussions with drug manufacturers to find appropriate alternate pathways to resolve the issues raised by the Agency in relation to the novel topical use of fluorescein.
The Company is also concurrently exploring alternative approaches for non-topical fluorescein use, which may facilitate the progress of the InVivage® submission through alternative means, and simultaneously streamline discussions around the Company’s other devices with the Agency. The FDA have granted the Company additional time to explore these alternatives before finalising its latest Q-submission guidance. It is anticipated that these dealings will take place by end of Q4FY24, after which a decision will be made on the most appropriate path forward and the relevant clinical studies required to demonstrate utility and efficacy for oral imaging."
This is a quarterly that needs careful reading and interpretation, but we don't have the facts to try and estimate the time required for FDA appproval.
The fact that OIL has only five quarters of funding remaining (on a farly simplistic method for budgeting) suggests another fund raising will be necessary for product launch(es).
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- Ann: OIL March 2024 Quarterly Report and Appendix 4C
The share price movement today seems to suggest a bullish tone...
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