Information request for BLA 125478/0, August 2, 2013 - RAGWITEK

(System Info - 244618 RIVERS KATIE 08/02/2013 16:16:42 RIVERSK)
 ______________________________________________ 
From: Rivers, Katie
Sent: Friday, August 02, 2013 2:50 PM
To: 'Greenfeder, Scott'
Cc: Valenti, Elizabeth
Subject: Information Request BLA125478/0

Dear Scott,

We have the following information request for your BLA, STN125478/0:

Your pediatric study plan includes the following timelines for your proposed Phase 3 safety and efficacy study to evaluate 12 Amb a 1-U of Short Ragweed Pollen Allergen Extract (MK-3641) compared to placebo in subjects 5 to 17 years of age with ragweed pollen induced rhinoconjunctivitis:

Protocol completion: Q1 2015
 First subject in: Q4 2015
 Study completion: Q4 2016
 Final Clinical Study Report submission: Q2 2017
 Please provide a justification for your proposed timelines for this study.

Please contact me if you have any questions.

Thank you,
 Katie

Katie H. Rivers, M.S.
 Regulatory Project Manager, CMC1
 FDA/CBER/OVRR/DVRPA
 1401 Rockville Pike, HFM-481
 Rockville, MD 20852

Phone 301-796-2640
 Fax 301-827-3532
