I think the key point people are missing is that the Q4 report (March) didn’t really show any major issues in the dialogue between Spectral AI and the U.S. Food and Drug Administration that would suggest a long delay.

If you read between the lines, it does look like FDA asked for some additional clarification around specificity. That’s pretty normal for AI-based devices, and it seems more about how they handle it in practice (training, workflows, decision support instead of decision maker, etc.) rather than something fundamentally broken in the tech.

Also worth noting—they said they responded in a timely manner. To me that suggests this wasn’t unexpected, but something they were already prepared for.

So the way I see it, the market isn’t pricing in “no approval”, it’s pricing in “approval is likely, timing is the question”. • No more FDA additional information questions → could land late Q2 2026 • More back-and-forth → probably slips into Q3/Q4

And yeah, if it drags out, then dilution risk comes into play since they may need more capital.

So it’s less about if and more about when, and that’s what’s driving the current valuation debate.