Ann: Pre-Submission package lodged with the US FDA, page-5

It's ridiculous.

The line that gets me is "We expect to have a number of meetings with the agency (FDA) this year to ensure that the company is well positioned and to provide any additional details that might be required"

This means don't expect anything meaningful for months...and months.

Then they have to go through the pre-market submission after this.

Hardly a price sensitive ann. Basically "We've made a powerpoint presentation that we're lodging"