RE:RE:FDA Decides to Advise Public Re: "Emerging Signals"...Yes. We are waiting. "So are the fishes." :)
I think investors and the market must also take into account, as I and others noted much earlier this year, that Olympus's relationship with the FDA is very clouded due to past and present legal issues. Recall that Olympus was just trying to get out from under the damaging accounting scandal that broke in Fall of 2011 and resulted in jail time for at least 3 leading executives at Olympus, when, earlier this year they agreed to pay a $646 M US fine to the DOJ for essentially being involved in and perpetrating a scheme of systemic bribery with hospitals and other health care providers in order to promote the use of their equipment and devices in the US. Now, add to this the more recent class action and other law suits against Olympus relating to the contaminated scope problems of the past 3 or 4 years, and their executives 'taking the 5th' in court a few days ago to order avoid, for the time being, revealing more damning evidence and exposing themselves and their company to further probably inevitable legal entanglements and significant financial penalties and settlements, and I suspect Olympus is a company that is not particularly interested in cooperating with the FDA, or TSO3 for that matter, in admitting that a contaminated scope problem even exists, let alone properly addressing a permanent and definitive solution to this problem.
Don't forget: the VP4 is recognized in Canada and in Europe as being capable of sterilizing the number one duodenoscope in world use, the Olympus Q180V. Of this there is no doubt.
But, Olympus, no matter what they say publically, is, IMHO, unlikely to cooperate with the FDA in finding a sterilization solution beyond simply updating their protocols for reprocessing their scopes in their level disinfection washer (that the FDA I believe does not even recognize as one of the approved washers for this purpose), and they will do their best to continue this charade until the FDA and others, and the market, forces them to comply. Also, Olympus will continue to try to spuriously cast blame for contamination onto the technicians who could possibly have used improper reprocessing techniques in handling their scopes. As I have noted previously, IMHO, for Olympus to cooperate (with TSO3 and the FDA, for example) in finding a permanent definitive solution (the VP4) to the present duodenscope contamination scandal is for Olympus to admit that a problem exists, (that a scope, such as the Q180V, was the source of contamination and did cause harm to patients), and I expect they will be trying to deny relevant causal connections as long as legally possible, (by 'taking the 5th' at each and every possible opportunity, including with the FDA), for liability and financial reasons.
My understanding, and correct me if I am in error, is that for TSO3 to be able to add the Olympus Q180V duodenoscope to their US Compatibility Matrix, as it has been added long ago to the Canadian Compatibility Matrix, would normally entail the company, Olympus, requesting validation testing at TSO3's new compatibility testing facility in MB and then this data would be submitted to the FDA for consideration and approval, before the scope is listed as compatible and sterilizable for the US. However, my analysis above makes me guess that Olympus will be unlikely, (against all humanitarian logic and against the public's interest), to make such a cooperative request, either of TSO3 or the FDA. So, while TSO3 may have already completed testing proving the VP4 can sterilze the Olympus scopes according to the FDA testing protocols in addition to Canadian standards, I would anticipate that Olympus is stonewalling any dialogue with the FDA in this regard as they only want to deny that a problem exists and they will do their best to continue this charade until the FDA and others, and the market, forces them to comply.
This makes me wonder if TSO3 might be very wise to be submitting sterilization data first (like tomorrow? :) - if only!) on equivalent or similar duodenoscopes from other more likely cooperative, reputable, and smaller (less market share) manufacturers, instead of waiting while the Olympus legal wrangling and obstruction drags on into 2017. I can't imagine TSO3 has been leaving their new compatiblity facility underutilized, exclusively for the dear Q180V. They surely are testing and validating the VP4 for a host of other complex scopes, including duodenoscopes. Such submissions and approvals by the FDA regarding competitors' duodenoscopes would set new standards for the industry and (possibly hurt Olympus's market share all the while) by putting the duodenoscope 'ball' soundly into the FDA's court asap. Market pressures as well as the FDA might just be enough to get these weasels at Olympus to stop 'taking the 5th' and duly cooperate and meet the new standards that TSO3 is creating in the best interests of the public.
Just my thoughts.
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