The PMA module is interesting. EBR stated they have already...

The PMA module is interesting. EBR stated they have already submitted key components like device verification data, biocompatibility data, clinical data, and post market surveillance data.

I therefore wonder if the final module has been submitted in draft form? Given the breakthrough device designation, maybe the FDA is giving continuous feedback about the final details. This aligns with EBR’s confidence in getting FDA approval in Q1 2025.

I also note the timeline for submission has shifted from Q3 2024 to ‘subsequent to the half- year period’. I’m speculating the FDA is guiding the process now.

Overall the tone is very positive. Lots of forward looking statements, and management of expectations regarding the FDA process. Clearly much progress has been made.

Some costs have increased but Runway Capital didn’t fund the expected tranche in Q1 because the FDA submission target date wasn’t met. (CEO said this at a roadshow meeting). So more funds to follow soon, presumably. I can’t remember the sum, maybe $10 million from memory.

Meanwhile the form 10 registration with the US SEC is supposed to become effective no later than end of September. This has nothing to do with the FDA. It’s about financial transparency and reporting obligations. Coincidence? More alignment in my view.