Hello Harsh,
Without knowing the development program that might be a little difficult to answer. However, I think it might be worth to look at the FDA approval documents. This way you can get an idea from the review what questions FDA is considering during the review and maybe develop some questions for the EOP2. Lot of questions at EOP deal with dose and the right dose for Phase3 , P3 design , potential labeling implications, etc.
Here is the link to the FDA reviews of Cimzia.
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/125160s000TOC2.cfmLet me know if there is anything I can help with.
Immo
------------------------------
Dr. Immo Zadezensky
Head Global Regulatory and Scientific Policy (GRASP) US
Biopharma | Global Research & Development | Global Regulatory & RDQ
EMD Serono
A business of Merck KGaA, Darmstadt, Germany
EMD Serono Research & Development Institute
------------------------------
Original Message:
Sent: 21-Feb-2017 12:14
From: Harsh Raja
Subject: End of phase 2 meeting questions
Hello,
I am currently working on the assignment in which I have to prepare questions to ask the FDA in an End of Phase 2 meeting. I have been given Cimzia as the choice of antibody. So I have to consider the development of this antibody and have to prepare questions for the end of phase 2 meeting.
Can anyone provide examples of questions considering the development of Cimzia? Any relevant sources or articles will also do.
Thank you.
------------------------------
Harsh Raja
MSRA Candidate
Northeastern University
hkr21raja@gmail.com
------------------------------