(NGSX) FDA approval in 3Q11 // Blockbuster Potential

[BiotechMaster]

This undiscovered hot stock is trading below cash...Please Read

NGSX has a great product called Qutenza(Neuropathic pain) which is available on the Market in Europe and USA since mid 2010 .Qutenza sales could reach 300++Million per year .
sNDA submission for HIV-AN indication in 1H 2011.. FDA approval expected in 3Q 2011 .Qutenza has Blockbuster Potential in this new HIV indication .

Upcoming Major Milestones (click link):

http://www.wsw.com/webcast/roth24/ngsx/2__Slide24.JPG
sNDA submission in HIV-associated neuropathy to FDA in 1H 2011
Qutenza, which currently has U.S. orphan drug designation and fast track status, may be eligible for six-month priority review.

Asia/Latin America commercial partnership 1H 2011


Price Target: $15+ by year end


Neurogesx (NGSX)

Market Cap: 55.6 M
Cash: 57.7 M
Price: 3.13

Shares Out: 17.7 M
Float : ~ 4 M


Great article // A MUST READ !!!
Inside Wall Street: This Little Pharma May Have a Big Pain Reliever - DailyFinance


http://www.wsw.com/webcast/roth24/ngsx/2__Slide19.JPG
http://www.wsw.com/webcast/roth24/ngsx/2__Slide4.JPG
http://www.wsw.com/webcast/roth24/ngsx/2__Slide17.JPG


Stephen Ghiglieri, EVP, COO and CFO, commented, "We are pleased with Qutenza market acceptance to date and continue to believe that our focused approach to the launch will provide the foundation to enable Qutenza to achieve its market potential. Our decision to move forward with the submission of an sNDA for Qutenza in HIV-AN is a positive step towards potential Qutenza label expansion that, if approved, could significantly expand Qutenza's addressable market. Re-entering the clinic with a Phase 2 study with NGX-1998 is also a significant step forward for this promising product candidate."

Clinical Pipeline Update:

Following a recent meeting with the U.S. Food and Drug Administration (FDA), NeurogesX announced plans to submit a supplemental new drug application (sNDA) for Qutenza in the first half of 2011 for the treatment of HIV-associated neuropathy (HIV-AN) also known as HIV–distal sensory polyneuropathy (HIV-DSP). The sNDA is excepted to be submitted with data from two completed Phase 3 studies in patients with HIV-AN. Qutenza, which currently has U.S. orphan drug designation and fast track status, may be eligible for six-month priority review.

[BiotechMaster]

NGSX is on the move ..BUY with both hands there is no real support till $5 .

NGSX is a fantastic investment for the near and long term .

[BiotechMaster]

resistance not support ..sorry

[BiotechMaster]

I think NGSX will jump to $4.50-5 this week the stock is massive oversold .Load up the truck while you still can .GL

[BiotechMaster]

You have still the big opportunity to buy at a huge bargain .GL


New buy rating with 11$ target ..

5 Health Care Stocks With Upside - TheStreet

[BiotechMaster]

NGSX is moving back up... This stock will move up over the 200-Day Moving Average which is at $ 6.12 very soon .Anything below $5 is a pure gift .GLTA

MA50 = $ 4.66
MA200 = $6.12

Buy confirmed by Americanbulls
NGSX NEUROGESX INC

NGSX - SharpCharts Workbench - StockCharts.com

[BiotechMaster]

Nice going next jump is around the corner = Great Buying Opportunity .

[BiotechMaster]

We closed above $4 which is a good sign .Earnings coming on Monday i expect good news so i think we will see 5-6 dollar quickly in the coming days .Still a huge buying opportunity .GL

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NASDAQ:NGSX Technical Analysis

NASDAQ:NGSX - NeurogesX, Inc.
NGSX - Sector: Healthcare, Industry: Healthcare Facilities.
NGSX is currently trading in a positive uptrend with more buyers than sellers.
NGSX gained 1.52% on 03/24/11 and a total percentage of 28.42% in the past 5 day
NGSX is trading in the range of $3.12 - $5.80 in the past 30 days.
Money Flow Index (MFI) is bullish and moving up for NGSX.
The 10-day simple moving average is bullish and moving up for NGSX.
Average Trading Volume: Up Over 10%.
Commodity Channel Index (CCI) is bullish for NGSX.
Stock Performance on Mondays in the past 90 days: 8.83%
Stock Performance on Tuesdays in the past 90 days: -32.41%
Stock Performance on Wednesdays in the past 90 days: -21.53%
Stock Performance on Thursdays in the past 90 days: -13.53%
Stock Performance on Fridays in the past 90 days: 8.77%
Next Earnings Release Date: 03/28/11.
Stock Rating: Buy with a score of 4/5.

[madswa]

The below link says it has already been approved in US and EU

NeurogesX to pursue US label expansion for Qutenza - Pharmaceutical Business Review

"Qutenza, is a localized dermal delivery system containing prescription strength capsaicin that is currently approved in the US and the European Union. "

NGSX has plans to file sNDA in H1 2011 target price is between $10 -$15. Why is the target price so high even though it's approved in US/ EU?

[BiotechMaster]

Qutenza is approved for Neuropathic Pain but NOT for HIV-AN .There are NO approved treatments for this new indication which is a very lucrative Market for Qutenza .

AAPM: Capsaicin Patch Eases HIV Neuropathy Pain

Many investors looking for the next FDA Play and NGSX will be the next HOT STOCK for them once they get PDUFA date this Q or early 3Q .

NGSX is trading near cash and its soon an FDA play thats why its a great buying opp at current levels .GLTA