"if it be not now, yet it will come: readiness is all." Hamlet...

"if it be not now, yet it will come: readiness is all."

Hamlet - William Shakespeare

My friends,

Tiresias has been contemplating and reconsidering his views on the implications of the imminent FDA approval of Optiscan’s Real-time Confocal digital laser microscope enabling real-time cellular histopathology in the operating room and the clinic. At times, Tiresias has been less than complimentary on the whole FDA approval process manner. He will not reiterate these criticisms. However, for Optiscan, and us the shareholders waiting on the FDA is now getting very interesting, nay a touch exciting. Though Tiresias is not one to get easily excited, he must confess that there is a certain frisson starting to build. There are several important points which he would like to make today.

First, we must recognise that the FDA approval process for devices is quite different to the approval process for drugs. Though there is still a bureaucracy there is a new imperative at FDA to optimise and facilitate the whole process. Optiscan in fact, was the first company to apply for approval on the new FDA totally online digital platform, something long overdue. As a result of this and the fact that this is a device and not a drug, Tiresias would expect a much faster process and quicker approval than we may have expected. As each week passes, we are getting that much closer to news, and big news. But why does this matter that much? After all, Optiscan technology already has two FDA approvals. However, this is different. The extant approvals are through Carl Zeiss for the CONVIVO, and through Pentax for the gastroenterological endomicroscope. This will be the first time that Optiscan, per se, on its own, will have an FDA approval, under their own banner. Suddenly investors, venture capitalists and pharmaceutical and medical instrument companies will have Optiscan on their radars. What else?

Well obviously, for the first time ever, Optiscan will be free to sell directly to doctors, hospitals, and clinics around the world. Thus far the only sales that Optiscan has had is supplying Carl Zeiss and previously Pentax, and an occasional sale of the research instrument.

Third, and as a consequence, Tiresias expects a significant re-rating in the market. Tiresias notes, every time there is an FDA for device or drug there is a there is a major pop of the share price. Tiresias can see that there is now a positioning taking place in anticipation. You see, in the last quarterly, Optiscan indicated they are talking to majors and venture capitalists about and Tiresias understands how this works. These groups are watching and have been eyeing the technology raring to make their move ahead of some others who might just learn about it when the FDA approval comes through. These financial and medical venture capital and medical devices groups, who are in dialogue with Optiscan are awaiting FDA approval. You see, these companies work differently to us ordinary shareholders. They have to justify their decisions and they do not mind paying orders of magnitude higher if they have the imprimatur of an FDA approval. They have directors and overseers they must justify their decision to. This is the time when individual investors can front run them. My friends Tiresias expects. Tiresias advises readiness.