![](http://investorshub.advfn.com/images/default_ih_profile2_4848.jpg?cb=0)
Thursday, October 04, 2007 6:40:18 PM
*Sorry if this has alrady been used as an example here; I've only recently begun reading this board.
===== "take into account that the data given in June deemed important enough to take further consideration leads me to believe that the chances are very high for approval. Either it be conditional or an outright approval. Rejection is not part of the equation at this point in time."
ENDP wanted a new indication (though very similar) for a drug which is currently approved (Frova). Even with very solid data, the FDA rejected because they questioned whether the benefit was clinically meaningful, and because they were worried about serious vascular adverse events, which ... are you ready for this ... were NOT observed in this drug-development program.
Sorry, but extensions don't mean approval.
JMHO,
NoBuddy
The FDA's first extension
==============================
CHADDS FORD, PA and WINNERSH, UK--(MARKET WIRE)--Mar 16, 2007 -- Endo Pharmaceuticals Holdings Inc. (NasdaqGS:ENDP - News) and Vernalis plc (LSE:VER.L - News) (NasdaqGM:VNLS - News) today announced that the U.S. Food and Drug Administration (FDA) has informed the companies that it will require an additional three months to review Endo's previously submitted Supplemental New Drug Application (sNDA) for Frova® (frovatriptan succinate) 2.5 mg tablets for the expanded indication of short-term prevention of menstrual migraine (MM). The agency now anticipates completing its review of this application on or before August 19, 2007. As previously disclosed, the original PDUFA (Prescription Drug User Fee Act) review date was May 19, 2007.
==============================
http://biz.yahoo.com/iw/070316/0227431.html
How good was the data? Pretty darn.
==============================
CHICAGO, IL--(MARKET WIRE)--Jun 9, 2007 -- Endo Pharmaceuticals Inc., a wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc. (NasdaqGS:ENDP - News), has presented results from a Phase III randomized, double-blind, placebo-controlled clinical trial evaluating FROVA (frovatriptan succinate) 2.5 mg tablets as a six-day preventative treatment in women with difficult-to-treat menstrual migraine (MM). The data demonstrated that FROVA significantly reduced the frequency and severity of MM as well as the disabilities related to them. The results, which were presented here today at the annual meeting of the American Headache Society (AHS), were from the second of the two successful Phase III placebo-controlled clinical trials evaluating the efficacy and safety of FROVA in MM prophylaxis.
==============================
http://biz.yahoo.com/iw/070609/0263950.html
The FDA's second extension - later announced as Sept. 30th
==============================
CHADDS FORD, PA and WINNERISH, UK--(MARKET WIRE)--Aug 16, 2007 -- Endo Pharmaceuticals Inc., a wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc. (NasdaqGS:ENDP - News), and Vernalis pls (LSE:VER.L - News) today announced that the U.S. Food and Drug Administration has requested an extension of the August 19, 2007 review date in order to have more time to review the supplemental New Drug Application for FROVA® (frovatriptan succinate) 2.5 mg tablets for the additional indication as short-term (six days) prevention of menstrual migraine.
==============================
http://biz.yahoo.com/iw/070816/0291901.html
Final Decision
==============================
TEL AVIV (MarketWatch) - An Endo Pharmaceuticals Holdings Inc. subsidiary and Vernalis Plc said on Sunday they received a non-approvable letter from the U.S. Food and Drug Administration on their request to extend the use of their migraine-headache medication Frova.
[...]
The FDA said that the clinical trials for the drug met their key endpoints by increasing the number of headache-free perimenstrual periods, the companies said.
But "it questioned whether the benefit demonstrated was clinically meaningful," they said in a statement. "The FDA also noted that even though serious vascular adverse events were not observed in this drug-development program, an increased risk (compared to the approved acute use) could not be ruled out.'"
==============================
http://www.marketwatch.com/news/story/endo-vernalis-set-back-extending/story.aspx?guid=%7BF3CC872F%2....
Recent SNGX News
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 08/16/2024 08:19:57 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/16/2024 08:13:45 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 08/09/2024 08:09:14 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 08/09/2024 08:07:35 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/09/2024 08:05:32 PM
- Soligenix Announces Recent Accomplishments And Second Quarter 2024 Financial Results • PR Newswire (US) • 08/09/2024 11:30:00 AM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 08/05/2024 04:15:07 AM
- Strong Clinical Momentum for Soligenix's HyBryte™ in Treating Cutaneous T-Cell Lymphoma; PCG Digital Exclusive with Dr. Brian Poligone • GlobeNewswire Inc. • 08/01/2024 01:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/25/2024 11:30:14 AM
- PRISM MarketView Features Q&A with Dr. Ellen Kim: Soligenix's HyBryte™— Lighting the Way Towards Commercial Success with Promising FLASH Study Results • GlobeNewswire Inc. • 07/15/2024 02:16:25 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/09/2024 05:28:54 PM
- Expanded HyBryte™ Treatment Demonstrating Positive Outcomes in Early-Stage Cutaneous T-Cell Lymphoma • PR Newswire (US) • 07/09/2024 11:30:00 AM
- Soligenix Announces Positive Clinical Results from a Comparative Study Evaluating HyBryte™ Against Valchlor® in the Treatment of Cutaneous T-Cell Lymphoma • PR Newswire (US) • 06/25/2024 11:30:00 AM
- A Comparison of Vaccine Technologies to be Presented at the ASM Microbe Conference • PR Newswire (US) • 06/14/2024 11:30:00 AM
- Setting the Stage for Success: PRISM MarketView Highlights Soligenix's Promising HyBryte™ Replication Trial • GlobeNewswire Inc. • 06/05/2024 12:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/31/2024 12:00:25 PM
- Soligenix Announces Reverse Stock Split • PR Newswire (US) • 05/31/2024 11:30:00 AM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 05/29/2024 08:05:07 PM
- Soligenix Encourages Stockholders to Vote their Shares at the Annual Meeting • PR Newswire (US) • 05/29/2024 11:30:00 AM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 05/28/2024 08:08:23 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/24/2024 08:05:27 PM
- Soligenix, Inc. Announces Adjournment of Annual Meeting, Information for Reconvened Annual Meeting • PR Newswire (US) • 05/24/2024 11:30:00 AM
- Soligenix Encourages Stockholders to Vote "FOR" Reverse Stock Split • PR Newswire (US) • 05/23/2024 11:30:00 AM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 05/22/2024 08:05:06 PM
- PRISM MarketView Highlights Soligenix, Inc. as it Builds on Compelling Phase 3 Data with Key Catalysts on the Horizon • GlobeNewswire Inc. • 05/21/2024 04:35:16 PM
HealthLynked Corp. Announces Second Quarter and First Half 2024 Results: Continued Cost Reductions Set the Stage for Strategic Shift to App-Based Technology Services • HLYK • Aug 16, 2024 8:00 AM
PickleJar Announces Official Name Change and New Ticker Symbol • NREG • Aug 15, 2024 2:23 PM
VAYK's Q2 Profit Added to Accumulated Net Profit of Over $2.2 Million In 18 Months • VAYK • Aug 15, 2024 9:07 AM
Swifty Global Reports Strong Q2 Performance and Prepares for Major Exchange Uplisting • DRCR • Aug 15, 2024 9:04 AM
Mayback's Global Entertainment Signs Global Distribution Agreement with Children's Media Studio • AHRO • Aug 15, 2024 8:45 AM
POET Technologies Reports Second Quarter 2024 Financial Results • POET • Aug 15, 2024 8:04 AM