NeurogesX Reports Second Quarter 20...(on by the FDA in support of regulatory a...)

Date:8/7/2009

on by the FDA in support of regulatory approval; outcomes and interpretation of the results of clinical trials; plans for commercialization of Qutenza, including, the capabilities of NeurogesX' and its partners to commercialize and distribute Qutenza as well as continue development activities with Qutenza, NGX-1998 and other product candidates; plans for entry into a U.S. commercialization partnership, including the timing with respect to entry into such a partnership; strategies to obtain reimbursement for end-users of Qutenza; the tolerability profile and/or benefits of NeurogesX' product candidates; expectations regarding expenses and cash burn rate as well as receipt of any payments from partners; ability to secure adequate or additional financing; and the sufficiency of cash resource to fund the Company's operations for at least the next 12 months. Such statements are based on management's current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to; positive results in clinical trials may not be sufficient to obtain FDA approval; the FDA may request additional clinical trials or other information prior to granting approval for Qutenza; any regulatory approvals which are received may be limited to certain indications; NeurogesX' product candidates may have unexpected adverse side effects or inadequate therapeutic efficacy or tolerability; physician or patient reluctance to use Qutenza or NGX-1998, if approved, or the inability of physicians to obtain sufficient reimbursement for procedures associated with NeurogesX' products; and other difficulties or delays in, clinical development of, and obtaining regulatory approval for NeurogesX' product candidates. For further information regarding these and other risks related to NeurogesX' business, investors should consult NeurogesX' filings with the Securities and Exchange Commission.

                              
'/>"/>
SOURCE  NeurogesX, Inc.
Copyright©2009 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3 4 5 6 7 8 9 10 11 12 
Related biology technology :

1. NeurogesX Announces New PDUFA Date for Qutenza(TM) New Drug Application
2. NeurogesX to Hold Conference Call to Discuss Second Quarter 2009 Financial Results
3. NeurogesX Added to Russell 3000 Index
4. NeurogesX Provides U.S. Regulatory Update for Qutenza(TM)
5. NeurogesX to Present at Needham Life Sciences Conference
6. NeurogesX Receives European Commission Approval for Qutenza(TM)
7. NeurogesX Reports First Quarter 2009 Results
8. NeurogesX to Hold Conference Call to Discuss First Quarter 2009 Financial Results
9. NeurogesX Presents Two Posters at 61st Annual American Academy of Neurology Annual Meeting
10. NeurogesX to Hold Conference Call to Discuss Fourth Quarter and Year-End 2008 Financial Results and European Regulatory Update
11. NeurogesX Qutenza(TM) (NGX-4010) Receives Positive Committee Recommendation in European Union