You really have no idea how much information goes into this type of submission. I would rather they get it right first time, than have to keep going back and forth.
They have been saying by year end for sometime now, so good to see this is still on course.
These are not forms. Fillings are super complicated regulator package that consist all your clinical data and manufacturing, Qualtiy control, facility information. Everything needs to be accurate and verified. At big company sometimes it may take up to 1-2years w to prepare these docs depending size of programs
Exactly right Bourbon, exactly! Why in God's name does it take 6 months to fill out papers? Someone should ask them this directly. Since it is OUR investment money they are using we deserve answers. You would think knowing their stock is tanking that they'd push hard to get the paperwork submitted. I mean come on, if you have a product that you know will save lives, then DO SOMETHING.