What improvements would you like in Yahoo! Finance Message Boards? Please send us feedback.
Message Boards Settings NeurogesX, Inc. (NGSX) - Quote Info
FDA Qutenza patch anesthetic data     24-Jul-09 01:50 pm    
http://yahoo.brand.edgar-online.com/disp...

FDA chosen topical application consistant with one used by NeurogesX in trial.

"Preliminary results of Study C123 showed the mean duration of patch application was 60.2 minutes, versus a target duration of Qutenza patch application of 60 minutes. No patients removed the Qutenza patch prematurely (i.e.< 90% of the intended full application time).

The company expects to provide results from Study C123 to the FDA prior to the PDUFA date of August 16, 2009. The impact on the agency’s timing, if any, for an ultimate decision on the NDA is not yet known.

Dr. Jeffrey Tobias, NeurogesX’ Chief Medical Officer commented, “I am grateful to our clinical investigators and the entire NeurogesX team for working together to quickly complete this study. We believe that these results will address the FDA’s questions relating to the use of an FDA-approved topical anesthetic as part of the Qutenza treatment procedure.”

Jim
Rating :
 (1 Rating)
Rate it:
awful/not related to \pooraveragegoodexcellent

wralfnetiam

Male
Pompano Bea...


View Messages

Ignore User

Report Abuse

< Previous Message |   Next Message >
View: Simple | Summary | Expanded
As: Threaded | Msg List
Page 1 of about 1   First | < Prev | Next > | Last

Messages in Topic

Minimum rating: What's this?
  Subject Author Rating Time of Post (ET)  
 
FDA Qutenza patch anesthetic data
wralfnetiam (1 Rating) 24-Jul-09 01:50 pm  
 
With the compensation and option package they anno...
carylindsay... Rate it 29-Jul-09 01:16 pm  
 
Thought pdufa date pushed out till Oct/Nov
obu_timo Rate it 30-Jul-09 06:10 pm  
 
The FDA can do whatever -- they haven't annou...
biotechluvr Rate it 3-Aug-09 02:44 pm  
 
Where does it state the date was changed??? T...
lloyddobble... Rate it 3-Aug-09 11:53 pm  
 
There will be a 3 month delay due to sub...
rustymillet Rate it 5-Aug-09 06:59 am  
View: Simple | Summary | Expanded
As: Threaded | Msg List
Page 1 of about 1   First | < Prev | Next > | Last

NeurogesX, Inc. (NGSX)

Chart for NeurogesX, Inc. (NGSX)
On Dec 28: 7.42 0.00 (0.00%)
Symbol Lookup