AF is a well known dick. Do some research yourself
Post# of 30027
ya well what 8 questions and what is required in the answers to make one successful? he makes it seem like it's:
1) name
2) date
3) title
4) favorite color
5) do you want an ODD
6) are you a drug company
7) when do you want it
can you return this letter to the FDA
https://www.fda.gov/ForIndustry/DevelopingPro...efault.htm
It's somewhere in between, and stats say approx 2/3 of all applications are successful. No F-ing way any of us could do that. Big pharma's have experienced teams to do that. We've got a "boy" according to some of you, some angel lady, and a sleepy old man trying to do everything with nothing. And when you're not blowing through 4 Phase III trials a year and your shareholders are ancy and wondering what they heck you're doing with your time, you PR ODDs, heck yes you do , 100% of the time every time.