To your last question, I think there is massive efficiency in simultaneous jurisdiction regulatory application preparation, like standardization, leveraging the new reciprocal approval regs, etc.
If they wait for further combo results, some of which they have already, how would that impact what’s needed and the timeline to complete the application and likelihood for approval?
The reason why I don’t believe they would slow play the application — unless absolutely necessary — is the company is experiencing a liquidity crunch. If the theory holds that it’s the approval that sets everything else in motion, the company will need to continue its capital raising at a low share price.
This really is the time for the company to speak up.