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new chapter begins, lets see what they can do in 3 months!
gl
ngsx misses the boat, this time.....
http://www.bloomberg.com/news/2012-02-09/neurogesx-fails-to-win-u-s-fda-panel-backing-for-patch-to-treat-hiv-pain.html?cmpid=yhoo
NeurogesX Inc. (NGSX), a specialty drugmaker that has never reported an annual profit, failed to win the backing of a U.S. advisory panel for its patch to relieve painful nerve damage commonly associated with HIV.
The panel voted 12-0 that the San Mateo, California-based company didn’t provide substantial evidence that the product, Qutenza, works. The advisers to the U.S. Food and Drug Administration met today in Silver Spring, Maryland
The FDA staff raised questions in a report Feb. 7 whether the prescription-strength capsaicin patch proved “substantial efficacy” in treating pain caused by neuropathy linked to the virus. NeurogesX filed studies with the FDA that used alternative testing methods to show a “modest benefit,” said Randall Flick, associate professor of anesthesiology at the Mayo Clinic in Rochester, Minnesota, and acting panel chairman.
“I was really concerned about setting a precedent going forward, that bothered me a lot,” said Penney Cowan, executive director of the American Chronic Pain Association in Rocklin, California, and the panel’s acting consumer representative.
The FDA typically only accepts post-hoc studies it does itself, Bob Rappaport, director of FDA’s division of anesthesia, analgesia and addiction products.
Seeking Flaws
“We’re not biased when we’re doing these things,” Rappaport said. “We’re looking for the flaws.”
Rappaport called the lack of evidence “heartbreaking.”
“We’ll do our best to work with the sponsor to come up with the best and most efficient trial to hopefully get this approved in the not-too-distant future,” he said.
One-third of people with HIV/AIDS experience peripheral nerve damage caused by the virus or drugs used to treat it, according to the Center for Peripheral Neuropathy at the University of Chicago. More than 1.1 million in the U.S. are estimated to be infected with HIV, according to the Atlanta- based Centers for Disease Control and Prevention.
The FDA is scheduled to decide whether to approve Qutenza by March 7. The agency doesn’t have to follow the advisory panel’s recommendation.
No FDA-approved drugs exist for HIV-associated neuropathy, according to NeurogesX. Painkillers and narcotics are recommended to treat the condition, according to the Center for Peripheral Neuropathy. Capsaicin is the chemical that makes chili peppers hot.
The FDA approved Qutenza in November 2009 for lasting pain after a shingles infection. The product sells for $675 a patch and has almost 1,000 customers, Anthony DiTonno, former president and chief executive officer, said at the Lazard Healthcare Conference, according to a Nov. 18 transcript.
The FDA found one test showed Qutenza worked when used for 90 minutes and failed to show effectiveness when used for an hour or 30 minutes. Later analyses based on alternative testing showed the 30-minute application worked, the agency said.
Qutenza failed to show efficacy in hourlong and 30-minute uses in a second study, according to FDA’s staff report. Again using alternative testing later, the patch showed it worked in the 30-minute application.
To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net.
To contact the editor responsible for this story: Adriel Bettelheim at abettelheim@bloomberg.net.
ngsx misses the boat, this time.....
http://www.bloomberg.com/news/2012-02-09/neurogesx-fails-to-win-u-s-fda-panel-backing-for-patch-to-treat-hiv-pain.html?cmpid=yhoo
NeurogesX Inc. (NGSX), a specialty drugmaker that has never reported an annual profit, failed to win the backing of a U.S. advisory panel for its patch to relieve painful nerve damage commonly associated with HIV.
The panel voted 12-0 that the San Mateo, California-based company didn’t provide substantial evidence that the product, Qutenza, works. The advisers to the U.S. Food and Drug Administration met today in Silver Spring, Maryland
The FDA staff raised questions in a report Feb. 7 whether the prescription-strength capsaicin patch proved “substantial efficacy” in treating pain caused by neuropathy linked to the virus. NeurogesX filed studies with the FDA that used alternative testing methods to show a “modest benefit,” said Randall Flick, associate professor of anesthesiology at the Mayo Clinic in Rochester, Minnesota, and acting panel chairman.
“I was really concerned about setting a precedent going forward, that bothered me a lot,” said Penney Cowan, executive director of the American Chronic Pain Association in Rocklin, California, and the panel’s acting consumer representative.
The FDA typically only accepts post-hoc studies it does itself, Bob Rappaport, director of FDA’s division of anesthesia, analgesia and addiction products.
Seeking Flaws
“We’re not biased when we’re doing these things,” Rappaport said. “We’re looking for the flaws.”
Rappaport called the lack of evidence “heartbreaking.”
“We’ll do our best to work with the sponsor to come up with the best and most efficient trial to hopefully get this approved in the not-too-distant future,” he said.
One-third of people with HIV/AIDS experience peripheral nerve damage caused by the virus or drugs used to treat it, according to the Center for Peripheral Neuropathy at the University of Chicago. More than 1.1 million in the U.S. are estimated to be infected with HIV, according to the Atlanta- based Centers for Disease Control and Prevention.
The FDA is scheduled to decide whether to approve Qutenza by March 7. The agency doesn’t have to follow the advisory panel’s recommendation.
No FDA-approved drugs exist for HIV-associated neuropathy, according to NeurogesX. Painkillers and narcotics are recommended to treat the condition, according to the Center for Peripheral Neuropathy. Capsaicin is the chemical that makes chili peppers hot.
The FDA approved Qutenza in November 2009 for lasting pain after a shingles infection. The product sells for $675 a patch and has almost 1,000 customers, Anthony DiTonno, former president and chief executive officer, said at the Lazard Healthcare Conference, according to a Nov. 18 transcript.
The FDA found one test showed Qutenza worked when used for 90 minutes and failed to show effectiveness when used for an hour or 30 minutes. Later analyses based on alternative testing showed the 30-minute application worked, the agency said.
Qutenza failed to show efficacy in hourlong and 30-minute uses in a second study, according to FDA’s staff report. Again using alternative testing later, the patch showed it worked in the 30-minute application.
To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net.
To contact the editor responsible for this story: Adriel Bettelheim at abettelheim@bloomberg.net.
i'm just keeping an eye on it, as i think this potentially a winner, especially with its epo alternative, etc.
but the lack of clarity is concerning.
sent several emails and will look forward to there replies.
this trading purely on speculation byt the biomedreports. therefore be careful at this juncture.
gl
pending review, taking a lot longer than i expected!
was hoping for 1pm open!
gl
Agree, mdgn need to be more transparent with the finances and filings. Though, it has huge potential!
Revenu is still some time away!
Speculation is driving this now, which is not a bad thing!
Gl
http://www.fdatracker.com/2012/02/08/ngsx-neurogesx-fda-advisory-committee-behavioral-analysis/
i dont necesarily buy into this article, but found it interesting read......at best.
gl to all!
likely run prior to the march date, and agree, with the neagtive brief, it has become pure specualtive play on trading fundamentals esp with the tight share count.
still has shot, though!
gl
left a third of my shares in play for march and will look to renter at the end of feb.
high risk and high reward.
gl
not expecting that much volatility or swing.
the news is not good, and most of the the bad news is already built in.
high risk-high reward, and we are teetering twd the risk side.
gl
first 30 minutes of trading should dictate the support levels!
expected sell off due to less than heartfelt review.
gl
briefing docs:
initial review does not look good, as thus the the pre market activity.
setback, but lets see how this develops:
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndLifeSupportDrugsAdvisoryCommittee/UCM290278.pdf
The indication that the Applicant is seeking, pain associated with HIV-PN, is a serious condition affecting approximately 40% of HIV patients. There are no FDA-approved therapies for this indication. Therefore, there is a medical need for an effective therapy.
Two efficacy studies were submitted to support the efficacy of Qutenza®; neither achieved their objective for the pre-specified primary efficacy analysis. Specifically, Study C107 failed to demonstrate superiority for the 60-minute Qutenza® application compared to low-dose capsaicin controls. The 30-minute application was superior to the total control treatment arm (i.e., control 30-, 60-, and 90-minute applications) and the control 30-minute application treatment arm. These efficacy results were not sensitive to missing value imputation or sensitivity analyses (i.e., the landmark analyses, with and without covariates). Further, secondary endpoints were in favor of the 30-minute Qutenza® patch application.
Study C119 also failed on its pre-specified primary analysis, possibly due to a better low-dose capsaicin control response, failure to adjust for covariates and potential outliers. Post-hoc analyses (adjusting for additional covariates, removing a potential outlier, and non-parametric analyses) provided supportive evidence.
The safety profile was comparable to what was reported in the PHN clinical development program. In general, Qutenza® 30-minute applications were associated with less pain, lower increases in blood pressure, less dermal irritation, and less medication use for treatment-related discomfort compared with longer (i.e., 60- or 90-minute) application durations.
50
Background Material - sNDA 22395/S-013
Qutenza® for the Management of Neuropathic Pain Associated with HIV-PN
7 Draft Topics for Discussion
1.
Considering that a dose-response was not observed in Study C107 and that the efficacy results of the 60-minute and 30-minute applications of Qutenza® failed to achieve statistical significance based on the pre-specified hierarchical testing procedure, has the efficacy of the 30-minute application of Qutenza® been demonstrated for the management of neuropathic pain associated with HIV-PN?
2.
Considering that Study C119 failed to achieve statistical significance for the primary efficacy outcome based on the pre-specified analysis, do the results of this study support the efficacy of the 30-minute application of Qutenza® for the management of neuropathic pain associated with HIV-PN?
3.
Do the data from the two clinical trials, C107 and C119, provide substantial evidence of effectiveness of Qutenza® for the management of neuropathic pain associated with HIV-PN?
4.
If the answer to Question #3 above is no, what additional studies or data are needed, e.g., dose ranging studies and/or additional efficacy trials?
5.
Has the Applicant submitted sufficient safety data to assess the safety profile of Qutenza® in the intended patient population?
6.
If you have determined that there is substantial evidence to support the effectiveness of Qutenza® for the management of neuropathic pain associated with HIV-PN, is the risk-benefit profile acceptable for Qutenza® to be approved for this indication?
51
Background Material - sNDA 22395/S-013
Qutenza® for the Management of Neuropathic Pain Associated with HIV-PN
gl
Ebix Announces Dividend, Fueling Stock's Rebound
By AMY REEVES, INVESTOR'S BUSINESS DAILY
Posted 02/03/2012 01:14 PM ET
Email Print License Comment
inShareFeatured Stocks
EBIX * Ebix Inc
* Top-Rated Company Ebix (EBIX) was up 4% in midday trading Friday after it announced a quarterly dividend of 4 cents a share. The move brought the stock to its highest point in 10 months, and was trading at about twice its normally modest average volume of about 530,000.
Ebix offers cloud-based software that connects insurance carriers, brokers and buyers online. It has reported a long string of growth quarters that have given it the highest-possible IBD Composite Rating of 99, but only a few Wall Street analysts cover it. It didn't help matters that last March a financial blog attacked its reporting practices at great length, leading to a sell-off from which the stock is still recovering.
The analysts who've stuck with the stock are expecting financials to slow down in the near future. When it reports Q4 results, likely in March, analysts expect per-share profit for 2011 to have risen 13% to $1.71, on sales of $168.2 million, up 27%. But for 2012, the consensus analyst estimate calls for 9.2% sales growth and earnings per share inching down 2% to $1.67.
estimates that are marginal and can be beaten!
http://news.investors.com/Article/599998/201202031314/ebix-stock-up-on-dividend-announcement.htm?ven=yahoocp,yahoo
Form 8-K for NEUROGESX INC
--------------------------------------------------------------------------------
6-Feb-2012
Entry into a Material Definitive Agreement, Unregistered Sale of Equity Securities,
Item 1.01. Entry into a Material Definitive Agreement.
The information set forth in Item 3.02 of this Current Report on Form 8-K that relates to the entry into material definitive agreements is incorporated by reference into this Item 1.01.
Item 3.02. Unregistered Sales of Equity Securities.
On February 3, 2012, NeurogesX, Inc. (the "Company") completed a private placement of its common stock under a Securities Purchase Agreement (the "Agreement"), dated as of January 31, 2012, by and among the Company and the Purchasers (as defined therein), pursuant to which the Company issued shares of common stock for an aggregate purchase price of $2,999,381.85, at a per share price of $1.01. The price of each share of common stock is based on the January 31, 2012 consolidated closing bid price of the Company's common stock on the NASDAQ Global Market of $1.01 per share. The total number of shares of common stock issued in connection with the transaction is 2,969,685. Bradford Goodwin, a member of the Board of Directors of the Company, was one of the Purchasers in the transaction.
The securities issued in the offering were sold pursuant to the exemption provided by Section 4(2) of the Securities Act of 1933, as amended, and by Regulation D promulgated thereunder. Pursuant to the Registration Rights Agreement entered into in connection with the Agreement, the Company agreed to file a registration statement covering the resale of the common stock no later than 60 calendar days from the closing date, and to seek to have such registration statement declared effective within a 120, 150 or 180 calendar day period from closing, with such period determined depending on certain conditions, or if the Company is notified by the Securities and Exchange Commission that the registration statement will not be reviewed or is no longer subject to further comment, the fifth trading day from the date that the Company is so notified by the Securities and Exchange Commission.
The foregoing is not a complete summary of the terms of the offering, Agreement, or Registration Rights Agreement described in this Item 3.02, and reference is made to the complete text of the form of Agreement and the form of Registration Rights Agreement attached hereto as Exhibits 10.1 and 4.1, respectively, which are incorporated by reference into this Item 3.02.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
The following Exhibits are filed as part of this Current Report on Form 8-K:
Exhibit
No. Description
4.1 Form of Registration Rights Agreement, dated as of January 31, 2012.
10.1 Form of Securities Purchase Agreement, dated as of January 31, 2012.
http://biz.yahoo.com/e/120206/ngsx8-k.html
BURLINGTON, Mass., Feb 01, 2012 (BUSINESS WIRE) -- Nuance Communications, Inc. /quotes/zigman/98548/quotes/nls/nuan NUAN +0.55% today announced that the Company will release results for its fiscal first quarter ended December 31, 2011, after the market close on Thursday, February 9, 2012.
Nuance will provide a copy of prepared conference call remarks in combination with its press release. This process and these remarks are offered to provide shareholders and analysts additional time and detail for analyzing Nuance's results. The remarks will be available at www.nuance.com/earnings-results in conjunction with the press release.
The conference call will begin at 5:00 p.m. EST and will include only brief comments followed by questions and answers. The prepared remarks will not be read on the call.
To access the live broadcast, please visit the Investor Relations section of Nuance's Website at www.nuance.com . The call can also be heard by dialing (800) 230-1093 or (612) 332-0107 at least five minutes prior to the call and referencing conference code 235385. A replay will be available within 24 hours of the announcement by dialing (800) 475-6701 or (320) 365-3844 and using the access code 235385.
About Nuance Communications, Inc.
Nuance /quotes/zigman/98548/quotes/nls/nuan NUAN +0.55% is a leading provider of speech and language solutions for businesses and consumers around the world. Its technologies, applications and services make the user experience more compelling by transforming the way people interact with information and how they create, share and use documents. Every day, millions of users and thousands of businesses experience Nuance's proven applications. For more information, please visit www.nuance.com .
SOURCE: Nuance Communications, Inc.
http://www.marketwatch.com/story/nuance-to-release-q1-fy-12-results-on-february-9-2012-2012-02-01
NGSX brief documents probably will be released tomorrow by the FDA, 2 days prior to the panel review.
could possible see $1.50 in the next 1-2 days, or downward depending on the context of the briiefs.
likely positive! (hope:))
gl
http://www.forbes.com/sites/ericsavitz/2012/02/06/nuance-thinkequity-ups-rating-to-buy-boost-target-price/
this company (NUAN) is still primed, despite the 52 week high created each week!
gl
wow!
280,000 (multiple) at $1.14
gl
i have no idea either!
gl
excellent article, that may drive up the stock market, and stabilizing the housing market!
http://www.cnbc.com/id/46275718
gl
the speculation could drive this above $1.50 prior to the review.
its the beauty and the gamble that makes this an exciting play!
gl
this is going to be a volatile play.
its pretty wound up, right now.
this could either be a $1.50 , or $5.00 run-up!
dont get greedy, as profit is profit!
gl
Source: NeurogesX
Date: February 03, 2012 16:15 ET
NeurogesX Grants Equity Awards Under Its 2011 Inducement Stock Plan
SAN MATEO, Calif., Feb. 3, 2012 (GLOBE NEWSWIRE) -- NeurogesX, Inc. (Nasdaq:NGSX), a specialty pharmaceutical company focused on developing and commercializing a portfolio of novel non-opioid, pain management therapies, today announced that the Board of Directors granted equity awards under its 2011 Inducement Stock Plan (the "Plan") to its recently appointed President and Chief Executive Officer Ronald A. Martell. The Plan was originally adopted by the Board of Directors in September 2011 pursuant to NASDAQ Listing Rule 5635(c)(4) as a means of making stock grants to senior executives as an inducement to their joining the Company.
Under the Plan, NeurogesX has granted non-qualified options to its President and Chief Executive Officer to purchase a total of 500,000 shares of its common stock. This grant was made as of January 30, 2012 at an exercise price of $1.07 per share, which is equal to the closing price of the Company's stock on the NASDAQ Global Market on the date of grant. The grant has a ten-year term and vests over four years with one quarter (1/4) of the shares vesting on the first anniversary of the grant date and an additional one forty-eighth (1/48) of the total shares vesting monthly thereafter, subject to continued service through each applicable vesting date.
In addition, NeurogesX granted 100,000 restricted stock units ("RSUs") to its President and Chief Executive Officer under the Plan on January 30, 2012. These RSUs vest over four years with one quarter (1/4) of the shares vesting on the first anniversary of the grant date and an additional one quarter (1/4) of the total number of shares vesting each year thereafter, subject to continued service through each applicable vesting date.
About NeurogesX, Inc.
NeurogesX, Inc. (Nasdaq:NGSX) is a specialty pharmaceutical company focused on developing and commercializing a portfolio of novel non-opioid, pain management therapies to address unmet medical needs and improve patients' quality of life.
The Company's lead product, Qutenza, is a localized dermal delivery system containing prescription strength capsaicin that is currently approved in the United States and the European Union. Qutenza is now available in the United States for the management of neuropathic pain associated with postherpetic neuralgia (PHN). In Europe, Qutenza is being marketed by Astellas Pharma Europe Ltd. (Astellas), the European affiliate of Tokyo-based Astellas Pharma Inc., for the treatment of peripheral neuropathic pain in non-diabetic adults, either alone or in combination with other medicinal products for pain.
The Company has submitted a supplemental new drug application (sNDA) to expand the U.S. label for Qutenza for the management of pain due to HIV-associated peripheral neuropathy (HIV-PN) previously referred to as HIV-associated neuropathy (HIV-AN) and HIV-distal sensory polyneuropathy (HIV-DSP).
The Company's most advanced product candidate, NGX-1998, is a topically applied liquid formulation containing a high concentration of capsaicin designed to treat pain associated with neuropathic pain conditions such as PHN. NGX-1998 has completed three Phase 1 clinical trials and one Phase 2 clinical trial in PHN patients.
The Company's early-stage pipeline includes pre-clinical compounds which include a number of prodrugs of acetaminophen. The Company has evaluated certain of these compounds in vitro and in vivo.
Safe Harbor Statement
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the Act). NeurogesX disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Safe Harbor for forward-looking statements contained in the Act. Examples of such statements include but are not limited to statements regarding: potential expansion of the U.S. label for Qutenza to include management of pain due to HIV-associated peripheral neuropathy (HIV-PN). 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: difficulties or delays in the further development of Qutenza for additional indications, including difficulties or delays in receipt of FDA approval of the sNDA to expand the U.S. label for Qutenza for the management of pain due to HIV-PN; market acceptance of Qutenza in already approved indications may not be sufficient to support further pursuit of an expanded label for Qutenza; and Qutenza, NGX-1998 and NeurogesX' other product candidates may have unexpected adverse side effects. For further information regarding these and other risks related to NeurogesX' business, investors should consult NeurogesX' filings with the Securities and Exchange Commission.
CONTACT: NeurogesX, Inc.
Stephen Ghiglieri
Executive Vice President, COO
and CFO
(650) 358-3310
sghiglieri@neurogesx.com
The Ruth Group
Stephanie Carrington (investors)
(646) 536-7017
scarrington@theruthgroup.com
Victoria Aguiar (media)
(646) 536-7013
vaguiar@theruthgroup.com
http://www.globenewswire.com/newsroom/news.html?d=244707
excellent!
this is testament for many who have accumaleted and held long.
this will only go higher in the near future!
strong support!
gl
i was tempted to play the short squeeze when i got out, and it seems it was good pretty good idea i didn't....lol
gl
been in this stock for only 4-5 months. and already share your feelings.
but profit is profit, and you can always get back on the dips.
gl to you
best long term play in my docket!
bullish: long term!
gl to all
looking very strong, ask is being nipped, as the bid has been stead fast at the .99 to 1.01 range.
gl to all
was basing this point on the Level 2 for the past few hours.
the behavior of the ask and bid has been supportive of the $1.00 floor.
gl
well, look how its trading now?
there are more affirmations when an institution invests in a company, yes things are not guaranteed, but what is?
gl
theoretically this should stabilize a new floor at $1.00 before the PDUFA, and thereafter!
gl
http://finance.yahoo.com/news/NeurogesX-Inc-Announces-3-0-pz-1361370383.html?x=0
SAN MATEO, Calif., Feb. 1, 2012 (GLOBE NEWSWIRE) -- NeurogesX, Inc. (Nasdaq:NGSX - News), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, today announced that on January 31, 2012 it entered into a securities purchase agreement in connection with a private placement to a group of institutional accredited investors and, subject to standard closing conditions, is expected to receive approximately $3.0 million in gross proceeds from the sale of 2,969,685 common shares at $1.01 per share based on the consolidated closing bid price of NGSX common stock on the NASDAQ Global Market on January 31, 2012. The funding was led by a large, global institutional investor and included certain other existing investors. The funding was initiated by an inbound inquiry.
The securities sold in the private placement have not been registered under the Securities Act of 1933, as amended, or state securities laws and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission or an applicable exemption from the registration requirements. NeurogesX has agreed to file a registration statement with the Commission covering the resale of the shares of common stock sold in the private placement.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.
About NeurogesX, Inc.
NeurogesX, Inc. (Nasdaq:NGSX - News) is a San Francisco Bay Area-based biopharmaceutical company focused on developing and commercializing novel pain management therapies. NeurogesX was founded on the concept that use of prescription-strength capsaicin could help manage the pain associated with neuropathic pain conditions. Since its inception, NeurogesX has leveraged its passion to help people with pain to efficiently develop this concept, resulting in the commercial launch of Qutenza (capsaicin) 8% patch in 2010. The Company continues to apply its knowledge and expertise in the development of other novel treatments for pain.
The Company's lead product, Qutenza, is a localized dermal delivery system containing prescription strength capsaicin that is currently approved in the United States and the European Union. Qutenza is now available in the United States for the management of neuropathic pain associated with postherpetic neuralgia (PHN). In Europe, Qutenza is being marketed by Astellas Pharma Europe Ltd. (Astellas), the European affiliate of Tokyo-based Astellas Pharma Inc., for the treatment of peripheral neuropathic pain in non-diabetic adults, either alone or in combination with other medicinal products for pain.
The Company has submitted a supplemental new drug application (sNDA) to expand the U.S. label for Qutenza for the management of pain due to HIV-associated peripheral neuropathy (HIV-PN), previously referred to as HIV-associated neuropathy (HIV-AN) and HIV-distal sensory polyneuropathy (HIV-DSP).
The Company's most advanced product candidate, NGX-1998, is a topically applied liquid formulation containing a high concentration of capsaicin designed to treat pain associated with neuropathic pain conditions such as PHN. NGX-1998 has completed three Phase 1 clinical trials and one Phase 2 clinical trial in PHN patients.
The Company's early-stage pipeline includes pre-clinical compounds which include a number of prodrugs of acetaminophen. The Company has evaluated certain of these compounds in vitro and in vivo.
Safe Harbor Statement
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the Act). NeurogesX disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Safe Harbor for forward-looking statements contained in the Act. Examples of such statements include but are not limited to statements regarding: the potential expansion of the U.S. label for Qutenza to include management of pain due to HIV-associated peripheral neuropathy (HIV-PN); the expected closing, and proceeds from, the private placement transaction and the registration of shares issued in connection with the private placement with the U.S. Securities and Exchange Commission. 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: difficulties or delays in the further development of Qutenza for additional indications, including difficulties or delays in receipt of FDA approval of the sNDA to expand the U.S. label for Qutenza for the management of pain due to HIV-PN; market acceptance of Qutenza in already approved indications may not be sufficient to support further pursuit of an expanded label for Qutenza; Qutenza, NGX-1998 and NeurogesX' other product candidates may have unexpected adverse side effects; and difficulties or delays in the closing of the private placement and subsequent registration of shares issued in connection with such private placement. For further information regarding these and other risks related to NeurogesX' business, investors should consult NeurogesX' filings with the Securities and Exchange Commission.
i think STX is where it should be, and deservedly so.
the question, is where is it going to be tomorrow, or few months.
enjoy the profits!
gl
TIMING!
GL
RENN is strong specualtive play in the short term. (always skeptical about the over inflation by the chinese regulators: opportunity too use it in your favor!)
AMLN is on fire in the pre market. tempted in getting out!-----pulled: for better or worse)
gl
there is something special here1
worth a hard look!
gl
http://seekingalpha.com/article/322589-earnings-preview-seagate-reports-q2-results-tuesday?source=cnbc
decent article, holding tight and not jumping back in yet.......
and where do we go from here.....?
gl
few discussion sites / articles....
http://neuropathyandhiv.blogspot.com/2011/10/qutenza-patches-for-neuropathy-pain.html
http://clinicaltrialsfeeds.org/clinical-trials/results/term=Qutenza
http://www.thepmd.com/neurogesx-reports-positive-phase-2-results-for-ngx-1998-for-treatment-of-postherpetic-neuralgia/article/216251/
good reading.
cheers