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Vorbörslich gibt es keine guten news zu einem Medikament.
Die Wirkung scheint nicht auszureichen um HIV Patienten zu helfen.
Ich sehe dies nicht so tragisch, da es nur eine zusätzliche Option für das Medikament gewesen wäre.
Vorbörslich wird die Aktie bei $0.87 gehandelt.
Werde nicht verkaufen sondern in dem Bereich unter $0.90 meine Positionen verbilligen!
NGSX briefing docs:
initial review does not look good, as thus the the pre market activity.
setback, but lets see how this develops:
www.fda.gov/downloads/AdvisoryCommittees/...ttee/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
Die Wirkung scheint nicht auszureichen um HIV Patienten zu helfen.
Ich sehe dies nicht so tragisch, da es nur eine zusätzliche Option für das Medikament gewesen wäre.
Vorbörslich wird die Aktie bei $0.87 gehandelt.
Werde nicht verkaufen sondern in dem Bereich unter $0.90 meine Positionen verbilligen!
NGSX briefing docs:
initial review does not look good, as thus the the pre market activity.
setback, but lets see how this develops:
www.fda.gov/downloads/AdvisoryCommittees/...ttee/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
Aktie hat sich vom Tagestief $0.7518 auf $0.90 erholt.
Der Abverkauf scheint überstanden!
Der Abverkauf scheint überstanden!
Shares of NeurogesX (Nasdaq: NGSX) have plunged nearly 21 percent in Tuesday's pre-market session as the FDA has raised concerned related to the effectiveness of the company's Qutenza patch.
From the FDA:
At this meeting of the AADPAC we will be discussing a supplemental application to NDA 022395, submitted by NeurogesX, Inc. in support of their proposal to add a new indication to the product labeling for Qutenza. Qutenza is an 8% capsaicin patch which was approved for the treatment of the pain of post-herpetic neuralgia in November of 2009. This supplement requests approval to expand the indication to include treatment of the pain associated with HIV neuropathy.
The sponsor has provided the results of two adequate and well-controlled clinical trials of Qutenza. Both studies employed the requested label dose (8%) compared to a very low dose capsaicin patch (0.04%) over different time-exposures. Study C107, evaluated the change from baseline average pain over 12 weeks after patch application for 30, 60 or 90 minutes. Study C119 again evaluated the change from baseline pain over 12 weeks, but after patch application for only 30 and 60 minutes. C107 did demonstrate a statistically significant treatment effect at 90 minutes, based on the pre-specified statistical analysis plan, but it failed to demonstrate statistical significance for the 30 and 60 minute applications compared to the low-dose control patch. Study C119 failed to achieve statistical significance on the pre-specified primary outcome analyses for either application time. In addition, the control patches applied for longer durations appeared to provide pain relief compared to baseline and to the Qutenza patches in both studies, in spite of the very low dose of capsaicin in these patches. The sponsor is requesting approval for Qutenza with patch application for 30 minutes. Statistical concerns regarding multiplicity, and the absence of replicated statistically significant results have raised the question of whether evidence of substantial efficacy has been demonstrated for this proposed treatment regimen.
From the FDA:
At this meeting of the AADPAC we will be discussing a supplemental application to NDA 022395, submitted by NeurogesX, Inc. in support of their proposal to add a new indication to the product labeling for Qutenza. Qutenza is an 8% capsaicin patch which was approved for the treatment of the pain of post-herpetic neuralgia in November of 2009. This supplement requests approval to expand the indication to include treatment of the pain associated with HIV neuropathy.
The sponsor has provided the results of two adequate and well-controlled clinical trials of Qutenza. Both studies employed the requested label dose (8%) compared to a very low dose capsaicin patch (0.04%) over different time-exposures. Study C107, evaluated the change from baseline average pain over 12 weeks after patch application for 30, 60 or 90 minutes. Study C119 again evaluated the change from baseline pain over 12 weeks, but after patch application for only 30 and 60 minutes. C107 did demonstrate a statistically significant treatment effect at 90 minutes, based on the pre-specified statistical analysis plan, but it failed to demonstrate statistical significance for the 30 and 60 minute applications compared to the low-dose control patch. Study C119 failed to achieve statistical significance on the pre-specified primary outcome analyses for either application time. In addition, the control patches applied for longer durations appeared to provide pain relief compared to baseline and to the Qutenza patches in both studies, in spite of the very low dose of capsaicin in these patches. The sponsor is requesting approval for Qutenza with patch application for 30 minutes. Statistical concerns regarding multiplicity, and the absence of replicated statistically significant results have raised the question of whether evidence of substantial efficacy has been demonstrated for this proposed treatment regimen.
meint ihr wo wir heute am handelsende stehn?
aktuell schöner tagesrebound
aktuell schöner tagesrebound
DIE FOLGENDE AKTIE IST AB SOFORT AUSGESETZT:
THE FOLLOWING SHARE IS SUSPENDED WITH IMMEDIATE EFFECT:
INSTRUMENT NAME KUERZEL/SHORTCODE ISIN BIS/UNTIL
NEUROGESX I8Z US6412521014 BAW/UFN
THE FOLLOWING SHARE IS SUSPENDED WITH IMMEDIATE EFFECT:
INSTRUMENT NAME KUERZEL/SHORTCODE ISIN BIS/UNTIL
NEUROGESX I8Z US6412521014 BAW/UFN
NeurogesX (Nasdaq: NGSX) today announced that the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) to the U.S. FDA did not recommend FDA approval of a new indication for Qutenza® (Capsaicin) 8% patch for the management of neuropathic pain (nerve pain) related to HIV associated peripheral neuropathy (HIV-PN).
While the FDA will consider recommendations of the Committee, the decision regarding the approval of a new indication is determined by the FDA. Currently, the Company's supplemental new drug application (sNDA) remains under evaluation, with Priority Review status granted by the FDA. A decision from the Agency is expected by March 7, 2012, under the Prescription Drug User Fee Act (PDUFA).
The Committee's recommendation followed today's presentations by the Company and the FDA. The Committee reviewed the efficacy and safety data from clinical studies of Qutenza® in the management of pain associated with HIV-PN.
Quelle: www.streetinsider.com/Corporate+News/...f+Qutenza/7157384.html
While the FDA will consider recommendations of the Committee, the decision regarding the approval of a new indication is determined by the FDA. Currently, the Company's supplemental new drug application (sNDA) remains under evaluation, with Priority Review status granted by the FDA. A decision from the Agency is expected by March 7, 2012, under the Prescription Drug User Fee Act (PDUFA).
The Committee's recommendation followed today's presentations by the Company and the FDA. The Committee reviewed the efficacy and safety data from clinical studies of Qutenza® in the management of pain associated with HIV-PN.
Quelle: www.streetinsider.com/Corporate+News/...f+Qutenza/7157384.html
da kommt nix mehr...
zu 99.9% wird keine Zulassung kommen.
zu 99.9% wird keine Zulassung kommen.
ist (siehe Insiderkäufe)!
Das passt alles irgendwie nicht ins Bild zu mal vor ein paar Tagen jemand für $3M zu $1.01 Aktien gekauft hat.
Höchst merkwürdig das ganze...
Höchst merkwürdig das ganze...
jetzt fast zum halben Preis! Da kommt noch was, da bin ich mir sicher!
Boden liegt zwischen $0.50 und $0.55 - Aktie ist total überverkauft.
www.mysmartrend.com/news-briefs/mannkind/...y-ngsx-incy-mnkd-0
Da die FDA in 99% der Fälle der Empfehlung des Panels folgt, wird hier wohl bald ein Chapter 11 geben.
Da die FDA in 99% der Fälle der Empfehlung des Panels folgt, wird hier wohl bald ein Chapter 11 geben.
für den hohen Anstieg, denn eigentlich sollte es ja heute einen auf den arsch geben?
Es gibt keine neuen Beiträge.
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5 | 56 | NGSX Turnaround in full play! | thekey | Joschi307 | 18.04.13 17:41 |
