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Hi Kseniasolothe Breakthrough Device Designation is not FDA...

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twigman7

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08/05/21

13:45

Post #: 53036995
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Originally posted by kseniasolo: ↑

This is what I have been wondering, too, but I go back to the theory of Breakthrough Device designation following a different procedure. If Nanodx has been working collaboratively with experts at the FDA during the development process they would be privy to information about when approval would/could be granted. They may be communicating this to the public but don't release a definitive statement to Sensera who would have to publish it to the ASX. The difference being one is bound by ASIC regulations and the other is not, so they can easily release "estimates" or "we think..." but not give Sensera anything in writing since that would be binding or "on record." Sensera is publicly traded while Nanodx and TPS aren't, so the way they communicate things is quite different. As Simon said, he expects the information would be price sensitive and they would have to release it to the ASX. Simon also told me that if Nanodx were communicating with the FDA, they would not be obliged to inform Sensera.

I spoke to Stewmack on Linkedin to seek clarity on what Breakthrough Device designation meant and this is what he had to say:

Stewart: A long story... but the breakthrough designation was designated to the technology pre-COVID as the original pathway for the device was to detect Traumatic Brain Injury and the FDA were in the loop during that period. Then COVID happened and the focus changed to adjust the solution to detect the C-19 virus. So the designation is for the technology and they are seeking EUA for the application within C-19 having already gained the CE mark

Me: I see, thank you for the explanation. Does this mean they had to start the whole process from scratch and that the breakthrough designation had to be reobtained? Or are they able to keep working with the process they had in place, just for a different application?

Stewart: Just different application, though the designation applies for TBI it validates the platform and the EUA will be for C-19

Me: Would that mean the expedited EUA review process still applies if the test's application is now for C-19 and not TBI?
Stewart: Yes - the EUA submission is for C-19Frankly, it's still not 100% clear to me. Ideally we could get in contact with someone from TPS or NanoDX and get confirmation of exactly what the Breakthrough Device designation process means in this case and if it still applies. I think this is the source of confusion for why the public seems to know about "submission" but not Sensera.

Alternatively, think about Covid vaccine development - as Pfizer and Moderna were working on theirs, they were sending this data to the FDA for review and collaborating with them to bring it to the market. As soon as all the data was ready, it only took a day for FDA to grant EUA. These both had Breakthrough designation. I assume it's a similar procedure here for Nanodx -- they're getting all the data they need and as soon as it's ready they can basically get the greenlight from the FDA, rather than have to submit that data in one batch and wait months for a review. But this is predicated on Stewmack being correct about breakthrough device designation.

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Hi Kseniasolo

the Breakthrough Device Designation is not FDA approval, it just means that the FDA scientists work with the company's scientists to make sure that when they do lodge for FDA approval it happens successfully. SM knows his stuff when he says it effectively keeping the fDA informed. Breakthrough Device Designation is a way of regulatory 'fast track', because the FDA process is so onerous, it behoves the Us Gov to assist industry to lodge successfully in the public interest.

EUA will only ever be for covid 19 because EUA is a fast track for emergencies where proper process cannot be followed. EUAs are available for public emergencies. Brain injury is not a public emergency.

SE1 Price at posting: 6.8¢ Sentiment: Buy Disclosure: Held
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