Incorrect. The company I mentioned is at fault with the delay. Not the FDA. The company has had to resubmit 2 times because of incomplete data and then has had a multitude of problems cited by the FDA at their manufacturing facilities. It's all on them, not the FDA.

AMBS is experiencing the difficulties of getting things done when they have to wait on others. Are their timelines aggressive? Yup. But I couldn't care less long term if they miss a milestone by several months. The milestones just need to eventually happen.