Comments for HEB Gets Response Letter From FDA at http://www.biomedreports.com , comment 1 to 2 out of 2 comments http://www.biomedreports.com Wed, 08 Feb 2012 18:38:35 +0100 FeedCreator 1.7.3 http://www.biomedreports.com/2009120119923/heb-gets-response-letter-from-fda.html#comment-1613 In the Non-Clinical area, the FDA is recommending that the Company complete rodent carcinogenicity studies in two species. As part of the NDA submission, the Company had requested that these studies be waived, but the waiver has not been granted. If I understand the above statement correctly, HEB submitted the NDA even though it did not include the data recommended by FDA. How can HEB say that it has a 80% chance of approval when the NDA does not include the data recommended by FDA? 1. When does FDA recommend HEB to include those data? 2. Did HEB ever inform us that the NDA does not include those data? - pcstock_cvm Tue, 01 Dec 2009 13:54:43 +0100 http://www.biomedreports.com/2009120119923/heb-gets-response-letter-from-fda.html#comment-1612 looks like its gonna slide real bad on wednesday morning. probably hit about 0.25 - 0.35. GLTA - Damon Tue, 01 Dec 2009 12:59:44 +0100