Does anyone have the knowledge on this type of spi

Does anyone have the knowledge on this type of spin (for NGIO) to know for sure if we need an S-1, how long this whole process would realistically take, etc.? I would love to hear a person in-the-know on this give their opinion on what the earliest date you think NGIO could be Naz listed, based on our current info.

I feel like end of month is a pipe dream... but I am admittedly working with limited knowledge...