Ann: FDA Supports Accelerated Approval Pathway for Heart Failure, page-247

I don't disagree with you, however the FDA was under immense pressure during Covid and approved almost nothing. Their CEO, while a supporter of progress and change, was waging a PR battle on TV and was caught up in the bipartisan politics of the US (Scott Gotlieb). At the same time clinical trials suffered, and the pace of change and scientific breakthroughs continue to accelerate. It has all added up to what is essentially an anomaly for the FDA.

The FDA is back on track, and the pace of approvals is rapidly gaining steam. Their messaging is that they want to approve. Look at the gene therapy space by way of example.

You are not wrong to be cautious, but I expect the current FDA to surprise in how quickly they progress this.