| HOME >> BIOLOGY >> TECHNOLOGY |
cts in clinical development or marketed products.
There can be no assurance that we will conduct additional CMV studies in the future. The FDA or other regulatory authorities may prohibit any future studies with maribavir or alternatively may require additional or unanticipated studies or clinical trial outcomes before granting regulatory approval. There can be no guarantee that we will be successful in gaining regulatory approval of maribavir for any indications. The data that were submitted to the U.S. Food and Drug Administration includes data from two separate studies including the pivotal Phase 3 study of Cinryze in acute HAE attacks and the ongoing open-label study of Cinryze for acute treatment of HAE, which includes partial data from an ongoing open label study. The FDA may view the data regarding the use of Cinryze for acute treatment of HAE we have submitted as a supplemental BLA as insufficient or inconclusive, not accept our submission, request additional data, require additional clinical studies, delay any decision past the time frames anticipated by us, limit any approved indications, deny the approval of Cinryze for acute treatment of HAE or approve a competing product which has been granted orphan drug designation thereby preventing Cinryze from reaching the market for acute treatment of HAE. There can be no assurance that the FDA or EMEA will not require additional or unanticipated studies or clinical trial outcomes before granting regulatory approval of any of our product candidates, or that we will be successful in gaining regulatory approval of any of our product candidates. Currently our market capitalization is less than our book value. As a result, we may be required to take a significant non-cash goodwill impairment charge and may be required to write off goodwill or other intangible assets in the future. If we are required to write off goodwill or other intangible assets, our financial position or resu
'/>"/>
| SOURCE ViroPharma, Inc. Copyright©2009 PR Newswire. All rights reserved |
Related biology technology :
1. ViroPharma to Present at Three November Healthcare Conferences
2. ViroPharma Enhances Leadership to Support Global Growth and Expanding Business
3. ViroPharma to Release 2008 Third Quarter Financial Results on October 29, 2008
4. ViroPharma to Present at Three October Healthcare Conferences
5. ViroPharma to Present at Three September Healthcare Conferences
6. ViroPharma To Acquire Lev Pharmaceuticals
7. ViroPharma Provides Update on Upcoming FDA Advisory Committee Meeting to Discuss Bioequivalence of Locally Acting Gastrointestinal Drugs
8. Viropharma Comments On Upcoming FDA Advisory Committee Meeting
9. ViroPharma to Present at Two Upcoming Healthcare Conferences
10. ViroPharma to Present at the Seventh Annual JMP Securities Research Conference
11. ViroPharma to Present at the Cowen & Company 28th Annual Healthcare Conference
| Copyright © 2003-2012 Bio-Medicine. All rights reserved. ABOUT | CONTACT US | DISCLAIMER | PRIVACY POLICY | TERMS AND CONDITIONS |  |