Tireseas : Pricing 2

“Byzantine (adjective) - something that is extremely complex, intricate, and often difficult to understand. .... excessively bureaucratic, convoluted, or involved in detailed and complicated procedures”

Dictionary: Oxford Languages

My friends,

Last week Tiresias examined the role of brokers and funds in the pricing of Optiscan shares. He raised the question of why Optiscan does not receive attention or support from brokers. Today he would like to address a point that would lead to a sudden re-rating of our share price.

Tiresias has discussed, often in somewhat negative terms, the FDA. In Tiresias’s opinion, which he has frequently expressed, this is one of the many agencies, of the federal government of the United States, which is rightly regarded with some disdain, for its multilayered complexities which are difficult for applicant companies to navigate. Ostensibly, these regulations and this complexity is necessary for public safety. In actual fact, this produces a confusing, arbitrary and inconsistent regulatory landscape which leads to unnecessary delays and expenses which are totally unnecessary.

Tiresias has looked at the reason for the delays in the FDA’s approval for Optiscan’s oral cancer system. Tiresias confesses that the complexity has eluded his understanding. Initially there was a delay requiring that the application be “de Novo” and not a 510, whatever that may mean. As far as Tiresias understands this should have been the simplest of application. It is not as if Optiscan’s CLE has not already received FDA and CE mark approvals, in Neurosurgery (CONVIVO), and for its GI instrument. Whilst the Kafkaesque request to apply via a different form, the FDA then changed the status of fluorescein, and required that each application, as far as Tiresias can understand, needs to be treated as a new drug or a new instrument or whatever. Why this should happen is beyond reason or understanding. Fluorescein has been administered topically and intravenously since the early 1960s and received full FDA approval in the early 1970s. Tiresias has not gone into major detail on this, as frankly, the path is a too complex to bother, but he sympathises with the Optiscan staff and CEO who have to comply with creatures of the Potomac swamp. Tiresias is certain that FDA approval is inevitable, but even he can’t read and untangle the inner workings that is the spaghetti junction that is the FDA bureaucratic “process”. Inevitable as the approvals are, and though Tiresias regards FDA with disdain, their approval is nevertheless very important and price sensitive. Potential buyers will be stimulated, brokers will have a reason to act, and most importantly funds will be interested, permitted and compelled to buy. These funds now also occupy a Byzantine universe, and have parameters such as market capitalization, inclusions in indices, and especially FDA approval, before they can buy on market. It is for this reason that Tiresias is confident, regardless of the importance or reasonableness of the FDA, the FDA tick will produce a price rise, no a jump, even a breakout.

Until next week