Dude, my poor friend, those primary endpoint statistics alone won’t be understood by lay public. They need a publication or presentation to give physicians even enough to contemplate the victory. How do you discuss a primary with three unique and advanced statistical design elements?
The timing of publication and approval will be happenstance in my mind. FDA and regulators work on schedules and timelines. Which would you work on first if you had limited resources and time, the approval process or a publication?
They can work on both but you only have one top priority. Money, money, money…money. And they need it desperately. What kind of revenue does a publication produce?
Go on past Aug 21 2015 - check with regulators on process.
Go past Feb 6 2017 - inform regulators and check opinion.
Go past Nov 2018 - work on new document to submit to regulators as well as new subtyping to ensure accurate designations
Go past Oct 5 2020 - work on submission to regulators and work on a publication for appropriate digestion of the facts in this case, brother.
The great and wonderful Dr. Linda Liau showed us the model design and showed us the SAP design. How much time do you think it would take after that? They had time to get started on remaining elements while she made her way to Mt. Sinai…and yes HappyLibrarian… Mt. Sinai is a religious based institution as well as the mountain top where Moses brought us the Ten Commandments. Though shalt not steal. Though shalt not bare false witness.
Happy, Are you saying Linda Liau has done at least one and a party to both?
I am running out of posts Poorman and need to be efficient, my guess is Happy is still reading my voice.
