Biotech Values

[drbio45]

"The extension is the result of DOR's July 13, 2007 provision of supplemental information to the orBec® NDA. This information was requested by the FDA at a June 13, 2007 NDA review meeting.""

http://biz.yahoo.com/iw/070719/0280047.html

On June 13, 2007 DOR met with the FDA to review and discuss the orBec® NDA. The discussion was productive and focused on ways to more fully elucidate the clinical effect and benefit of orBec® in the treatment of GI GVHD. Based on these discussions, the FDA requested that DOR review its existing clinical data from both its randomized, double-blind, placebo-controlled trials and highlight pertinent additional data that could provide a more comprehensive picture of orBec®'s clinical effect in treating acute GI GVHD. This new presentation of data formed the basis for the recently filed supplemental submission to the orBec® NDA. Following the FDA's review of this submission, it was determined that it constituted a major amendment. Given the close proximity of the submission of additional information relative to the July 21, 2007 PDUFA date, the FDA determined that a three month extension to the PDUFA date was necessary to allow for an adequate and complete review.

"We appreciate the FDA's willingness to allow us to provide supplemental data and for taking the additional time necessary to ensure a complete and high level review of the orBec® NDA," said Christopher J. Schaber, Ph.D., President and Chief Executive Officer of DOR. "We will continue to work with the FDA in every way possible to support their review so that it may be completed as expeditiously as possible."