Appreciate the frustration. I’ve not held as long, but still a...

Appreciate the frustration. I’ve not held as long, but still a fair amount of time.

This FDA is different. It has progressed to the final stage in a long process, they completed a clinical study, they’ve had an inspection of manufacturing. I suspect that prior attempts didn’t get past first base. They’ve also launched and gained market share in Canada, and are the go-to agent there.

Maybe they were naive in the past. But even children grow up,

Remember that they are in 60 countries, with around 4.5 million studies under their belt.

I can only assume that the FDA is impartial - the alternative is a scary thought.

The CRL is not the end of the matter. Sounds like it’s all addressable, but a 9–12 month delay nonetheless.

Agree that they over-hyped FDA as almost a certainty. Always better to underpromise.