I just spoke with Simon Peeke over the phone (you can of course take this with a grain of salt given my limited posting history, just as you can phone him yourself and confirm) and he said they have been getting a lot of calls recently asking for clarity on this matter.
He told me that they are not aware of NanoDX submitting for EUA validation. He also said Sensera would query if it's ASX sensitive, but his expectation is that it would be.
BUT...
The confusing among shareholders seems to come from Stewmack who keeps reaffirming that submission has taken place. My theory is that this has to do with how the Breakthrough Device designation process differs to the tradition FDA approval process. My suggestion is to
familiarise yourself with this whole process, as it is very different.
From the FDA's website:
The Breakthrough Devices Program offers manufacturers an opportunity to interact with the FDA's experts through several different program options to efficiently address topics as they arise during the premarket review phase, which can help manufacturers receive feedback from the FDA and identify areas of agreement in a timely way. Manufacturers can also expect prioritized review of their submission.
If we assume that what Stewmack
posted on linkedin is true, then this could explain the possible miscommunication.
Nanodx would be working collaboratively with the FDA throughout the development process and NOT following the traditional process of "independently create a finished device, collect the trial data, submit it to the FDA, and wait for approval." Instead Nanodx has been working with the FDA this whole time refining the kit and can expect a highly expedited review process once the device is ready to go to the market. This is also why I believe that -- according to Sensera's 4c -- Nanodx has asked them to ramp production for q1 fy22. The expectation from Nanodx is that, because they have worked with the FDA this whole time to refine the kit, as soon as it's actually ready for that final review, it would happen very quickly and they want Sensera to be ready within the next few months.
I explained these thoughts to Simon over the phone and he told me that he is honestly not privy to this process and Nanodx would
not be required to share this information with Sensera. So it is very likely that (again, if Stewmack is correct about the Breakthrough Device designation) Nanodx has been working with the FDA this whole time and can very quickly receive approval once they have deemed the device ready.
So, it is very plausible that what Stewmack has communicated to us this whole time has in fact been true, just not in the way we are all expecting the process to parse out. No, they have not directly applied for approval, BUT they have been working with the FDA throughout the design phase and the actual time between applying for final approval and receiving it will be very short.
I also take great faith in Turning Point beginning to be more public with their advertising, as it suggests to me that Nanodx have refined the kit to the point where they and the FDA believe that it would be ready to release. If that is the case, it should not take that long for approval. I personally expect within a month.
Again, the only thing in this post that is absolute is what Simon told me over the phone: they have not heard about Nanodx submitting for approval. Everything else is my understanding of Breakthrough Device designation and how that process works differently, which Simon told me they are not privy on. I suggest you do your own research and come to your own conclusion about what this process would entail. You are welcome to call Simon and ask him yourself, he was very friendly and happy to talk. They are just as eager as we are for the Nanodx kit to come off the ground.
