RE:RE:RE:RE:RE:Where is the blue sky?!?!?My (somewhat educated?) guess is that TSO3 has been doing additional tests on the updated Olympus Q180V scopes to meet some new or modified requirements that the FDA has put forward. TSO3 has had updated Olympus scopes for many months now, I believe, and, if it were simply a matter of repeating past tests on the updated scopes identical to past FDA submission protocols, we would have heard an announcement regarding the positive tests results and a claims submission for this scope to the FDA for their consideration before now.
I can only guess, as I have stated before, that the FDA is trying to be as careful as possible as they negotiate through a medical-legal quagmire in regards to the commonly used Olympus scope, as Olympus is presently under investigation (by the US Department of Justice, I believe) and the subject of some rather significant class action law suits regarding patient injuries and deaths due to the use of this scope and the apparent lack of clarity (to put it mildly) and the obfuscations of some N. American and Japanese executives about their internal knowledge of defects or problems with contaminated scopes in the past. This is going to cost Olympus dearly, to say the least, and you can bet the FDA doesn't want the buck stopping anywhere near their door.
And, as has been noted here, there have been repeated studies continuing to show upwards of 50% of scopes remain contaminated with bacteria even with relatively rigourous and properly performed high level disinfection reprocessing practices that the FDA has endorsed for some scopes. This is an FDA nightmare. You can bet that the FDA wants all testing and new claims protocols to be far beyond reproach or question and 'squeeky clean' (pun intended) before they accept TSO3's submission and consider going public with extended claims for the VP4's ability to sterilize this scope, even though this approval has already been given in Canada.
I am not privy to any information in this regard, but, given how long the FDA dragged their feet and the hoops they made TSO3 jump through to obtain their initial 510K approval and extended claims for the VP4 and its disruptive technology, as I have previously stated, I expect them to be slow at best with this process for the VP4, (even if they are unofficially aware of the efficacy of this sterilzation technology regarding the Q180V due to the previously reported open lines of communication between TSO3 and the FDA). As has been noted before, extending claims further for the VP4 will have enormous implications for FDA, Olympus, hospital, G I suite, physician, and patient lawyers, and the market, of course. On the other hand, I don't think the FDA will hesitate to endorse the VP4 and its technology by extending these claims and making the VP4 even more the defacto standard of care in the low temperature sterilization field though they are surely aware that extending claims approval to the Q180V will give TSO3 it a virtual market monopoly regarding claims to sterilize these and other complex scopes.
I hope to hear any time that TSO3 has submitted data for these claims, but I am not holding my breath. If we haven't heard this announcement before the first week of November, expect Rumble to have to clarify why not.
But, don't get too hung up on the duodenscope market, though it has been the one in the press: the the GI suite including the gastroscopes and colonoscope market is far larger than just duodenoscopes, and the VP4 is the FDA approved defacto standard with these, already. (Would you really want your colonscopy to be done using a scope that was just used on a patient with C. Difficile and was only disinfected with a reprocessor, or would you like to hear that the medical facility where you have gone for assessment and/or treatment can reassure you that the video colonoscope they are about to use is STERILE and poses no risk to you whatsoever no matter on whom it was recently used?)
This share price volatility is a buying opportunity, and I continue to add.
The sky is still very blue. Calm and clear.