Replies to post #744 on Soligenix Inc (SNGX)

[io_io]

<<<"Question? Did Dr. Padzur make the comment at the AC meeting that when we "FDA" give approval that there would need to be conditions.">>>

No he did not say such a thing.


<<<"If that is so the fact, and we then 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.">>>

Yes !

[jb_118]

"We then 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."

The fact that the FDA delayed the decision shouldn't be interpreted as either positive or negative. If applicant submits substantial additional information, the FDA delays a decision by 60 days. Substantial is not meant to imply whether the data are good or not, just whether they will take additional time to assimilate for analysis.

Off the top of my head, AVNR made a similar addition to their data package, got a 60 day extension, and was bludgeoned when the agency finally issued an approvable letter questioning the entire data package and demanding more trials. It wasn't even close.

[NoBuddyNoz]

RE: Extensions mean approval

*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
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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.
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http://biz.yahoo.com/iw/070316/0227431.html


How good was the data? Pretty darn.
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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.
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http://biz.yahoo.com/iw/070609/0263950.html


The FDA's second extension - later announced as Sept. 30th
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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.
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http://biz.yahoo.com/iw/070816/0291901.html


Final Decision
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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.'"
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http://www.marketwatch.com/news/story/endo-vernalis-set-back-extending/story.aspx?guid=%7BF3CC872F%2....