OIL 2.78% 18.5¢ optiscan imaging limited

The share price movement today seems to suggest a bullish tone...

ANNOUNCEMENT SPONSORED BY PLUS500
ANNOUNCEMENT SPONSORED BY PLUS500
CFD TRADING PLATFORM
CFD Service. Your Capital is at risk
CFD TRADING PLATFORM CFD Service. Your Capital is at risk
ANNOUNCEMENT SPONSORED BY PLUS500
CFD TRADING PLATFORM CFD Service. Your Capital is at risk
  1. 662 Posts.
    lightbulb Created with Sketch. 106
    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).
 
watchlist Created with Sketch. Add OIL (ASX) to my watchlist
(20min delay)
Last
18.5¢
Change
0.005(2.78%)
Mkt cap ! $154.5M
Open High Low Value Volume
18.5¢ 19.0¢ 18.0¢ $63.04K 340.5K

Buyers (Bids)

No. Vol. Price($)
1 100000 18.0¢
 

Sellers (Offers)

Price($) Vol. No.
18.5¢ 109961 2
View Market Depth
Last trade - 16.10pm 08/11/2024 (20 minute delay) ?
OIL (ASX) Chart
arrow-down-2 Created with Sketch. arrow-down-2 Created with Sketch.