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Synta’s (SNTA) Data Dredging/Statistical Debauchery 3 Jul 2012 | 06:10 am
Synta’s (SNTA) Data Dredging/Statistical Debauchery and Much More Last week, Synta released long awaited (I mean long awaited) results from an interim analysis of their open label Phase 2b GALAXY Stud...
Map Pharmaceuticals (MAPP): FDA Rejection (CRL) Review 5 Apr 2012 | 11:25 pm
Map Pharmaceuticals (MAPP): FDA Rejection (CRL) Review Map Pharmaceuticals recently received a complete response letter (CRL) from the FDA in regards to their lead product Levadex. In my last update o...
Missing In Action: Map Pharmaceuticals’ (MAPP) 2012 4th Qtr, 2012 10-K, and oh by the way: THE SPA 17 Mar 2012 | 02:56 am
Missing In Action: Map Pharmaceuticals’ (MAPP) 2012 4th Qtr, 2012 10-K, and oh by the way: SPA I’ve been keeping a keen eye out for Map Pharmaceuticals 4th qtr release because the company has an upcom...
Chelsea Therapeutics (CHTP): FDA’s Greatest Hits 23 Feb 2012 | 09:51 am
To be fair to Chelsea Therapeutics the company did preannounce disastrous FDA briefing documents. Unfortunately they didn’t mention just how big of a disaster the documents actually would be with stat...
Vivus (VVUS): Qnexa Briefing Documents Prep. 17 Feb 2012 | 07:25 am
Tomorrow the FDA is set to release their internal review of Qnexa for weight loss in what is referred to as the FDA briefing documents. Posted along with the FDA’s review will be questions the Advisor...
NeurogesX (NGSX): Chili Pepper Drug Qutenza 7 Feb 2012 | 06:52 am
My Opinion On February 9th, 2012 NeuroGesx will discuss with an FDA Advisory Committee as to whether or not the label for their currently marketed drug Qutenza (capsaicin 8%), that is currently approv...
Upcoming Events 13 Jan 2012 | 06:37 am
January 18 – CBRX FDA Briefing Documents released 19 – CTIC EU CHMP Pixantrone decision 20 – CBRX Ad-Comm 28 – ALKS, AMLN PDUFA for Bydureon February 4 – ALXA PDUFA 7 – CTIC FDA Briefing Documents rel...
Corcept (CORT): Mifepristone PDUFA Notes 11 Jan 2012 | 06:41 am
Corcept (CORT): Mifepristone PDUFA Notes This article will focus on Corcept’s PDUFA for Mifepristone for Cushing’s Syndrome. Cushing’s Syndrome is a rare hormonal disorder with no FDA approved therapy...
Arena Pharmaceuticals (ARNA) Conference Call Notes 5 Jan 2012 | 06:27 am
Arena Pharmaceuticals (ARNA) Conference Call Notes So these are some quick takeaways from Arena’s conference call yesterday: 1) Let’s start this off with the way in which the resubmission to the FDA w...
Alexza’s (ALXA) Briefing Documents: Greatest Hits 9 Dec 2011 | 07:47 am
So I decided to make this a post about the greatest FDA reviewer statements in their review of the Alexza Pharmaceuticals‘ lead product formerly called AZ-004. FDA’s review found here, and of course, ...
