Ann: Exercise of Options, page-56

What delay Snow?

If you were referring to prior posts in regards to MCIT/CMS Medicare coverage for Breakthrough Device Designation, this does not reflect on the FDA ruling for BDD, or for that matter anything to do with FDA de novo or 512K pathway in a pre-submission meeting. More to do with public consultation on public policy in regards to Medicare coverage.

So just for your FYI (everyone),

https://www.medtechdive.com/news/advamed-pushes-cms-to-implement-mcit-final-rule-without-further-delay/598600/

And the Response to the CMS by ACLA (American Clinical Laboratory Association) who are pushing for 5 years, not 4 years BDD Medicare coverage B4 review on approvals. There is a bit of a difference between LDTs & standardised testing vs BDD medical devices.

https://www.acla.com/acla-comments-on-medicare-coverage-of-innovative-technology-mcit/

I also think there is a pretty good argument presented there on definitions. Medical devices are a whole different kettle of fish to LDTs.

I’m not concerned, we have been counting down 10 weeks timeline for FDA meeting. It’s just ended from the ANN. Early days & I know I have so much FDA info in my head from reading so much on regulatory approvals & alternative pathways pre-approval....Richard has waited to go to the FDA with a mountain of data, far larger clinical trials than the only competitor (RenalytixAI) on BDD Approval for them, albeit a much larger MC & presence in the USA, plus listed on NASDAQ, so I think the outcome will be OK.

We should also remember the Ph2 study with Janssen (J&J) is for treatment with Canagliflozin (SGLT2i) so regardless of what PIQ do independently, this may result in a CDx, and that is another factor in what may have been discussed in that meeting...results now overdue! We’ll hear soon no doubt!

One thing PIQ don’t do is announce fluffy ANNs to appease impatient SHs, and for that I’m grateful.

GLTAH