“You don't need a record deal. You'll have the industry begging for you when you build your buzz."
Russell Simmons
My friends,
Tiresias has several points he wants to touch on this week. He is aware of his loquacious tendencies and hopes not to take up too much space and too much of your time. There have been several aspects and developments irrelevant to Optiscan he would like to comment on.
First, the was the publication of the Oral study from Melbourne. This, using three dye agents, fluorescein, acriflavine, and PARPi- FL have again shown the utility and the revolutionary potential of Optiscan’s confocal laser real time digital in-vivo endomicroscope in diagnosis and management of oral lesions, oral pre-cancer, and oral cancer. This shows that this is truly the state-of-the-art technology which must be introduced into clinical practice immediately. The only block to this is the delayed FDA approval.
By pure serendipity, Tiresias has been watching another ASX listed company, which has had similar issues with FDA, and a worse trajectory in its share-price. This company, Lumos Diagnostics (ASX-LDX), this past week, had a 1500% jump in its share-price, admittedly from a basement bottom level of 1 cent, on announcement that it has received FDA approval. In July 2022, LDX was knocked back by the FDA for its quest for approval for its medical technology on the grounds that; it "did not demonstrate substantial equivalence to the predicted device". LDX had at AUD$1.25. The cash was depleted, last week, the share price had shrunk to 1 cent, The company had failed in its appeal of FDA rejection and had to all over again for FDA approval. One year later, this past week, LDX announced the FDA, and jumped the said 1500%. Tiresias does not want to talk too much about this LDX’s technology, but essentially, it is a method for distinguishing between viral and bacterial infections. This is still a far cry from its original price but given its cash position and the process it had been through, it is a shot in the arm for the company and its shareholders, of whom Tiresias is not one. It has since called a trading halt, for a raising, to replenish its cash position, and has settle back to a more modest 900% jump. Tiresias must admit surprise at a 1500% jump on FDA clearance medical technology. As his friends would well know, Tiresias is not a fan of the FDA. In fact, he is a long-term critic and is highly sceptical of this over blown Washington bureaucracy. However, he must acknowledge its power in and influence on stock prices in the biomedical field, who must come before it.
It is now a few months since Optiscan has reapplied for FDA approval on a novo basis for clearance for its oral endomicroscope, the efficacy and safety has been so well demonstrated.Tiresias believes that after disappointment of the FDA’s advice for Optiscan to reapply and with this week’s ending of its fundraising, Optiscan’s share price is at its base. Tiresias will leave it for his friends to connect the dots.
One final point in today's Epistle is that Tiresias feels we are now in a waiting mode. Tiresias will therefor take another pause. Tiresias will hold off further missives until one of three developments he expects or something substantial occurs worthy of his comment. What he is looking to;
1. FDA approval for the oral endomicroscope
2. Release of the study for in vivo breast cancer surgery, which he expects to be even better and certainly more dramatic for the company than the oral cancer study.
3. and most dramatically, and some might say speculatively, an announcement of a deal or a joint venture with a major.
Until then Tiresias wishes his friends the best in the next short-term and hopes that his present sabbatical will not be long.
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