April 5th, 2012
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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 on the company I focused on the disappearance/misplacement/disagreement/(whatever you want to call it) of their Special Protocol Assessment agreement with the FDA and the company’s inability to file their 10-K within the “Accelerated Filers” 75 day window. Since that last update, the company received a CRL and also disclosed to their investors that the FDA had requested additional information on “Usability” late in the review process for their NDA. In my opinion, had the 10-K been filed in a timely manner, this request for additional information would have been most likely disclosed in the 10-K, had it been filed in the allotted window under SEC Release No. 33-8644. It wasn’t, so let’s move on. I will however revisit the SPA in this article. » Read more: Map Pharmaceuticals (MAPP): FDA Rejection (CRL) Review
March 16th, 2012
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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 upcoming PDUFA for their lead product Levadex. More specifically, I am interested in seeing what “interesting” new type of language the company would include in their 10-K around the loss or missing SPA agreement with the FDA for their Phase 3 trial of Levadex. I am also looking for new warning language around the PDUFA. However, the company has not yet filed their 10-k and it appears that they have missed the 75 day filing deadline set out by SEC rules for Public Companies that have been filing for more than a year and have a market cap of $75-700 million that are considered “Accelerated Filers” (SEC rules here). » Read more: Missing In Action: Map Pharmaceuticals’ (MAPP) 2012 4th Qtr, 2012 10-K, and oh by the way: THE SPA
February 22nd, 2012
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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 statements laden throughout the docs that FDA reviewers were openly opposed and recommending against approving their lead product Droxidopa. In fact, Chelsea management also forgot to tell their investors that the drug has deficiencies as well. Hmmm…..The other issue is that Chelsea was out on roadshows right before these documents were released, one has to wonder just how well prepared they are for an FDA gunning for them. » Read more: Chelsea Therapeutics (CHTP): FDA’s Greatest Hits
February 16th, 2012
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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 Advisory Committee is to discuss. This will just be a brief overview of possible considerations to take into account for the upcoming release in bulletpoint format. To note, I will focus on Safety/Risks, because to be honest I think Qnexa works by the FDA’s definition of efficacy unlike their competitors » Read more: Vivus (VVUS): Qnexa Briefing Documents Prep.
February 6th, 2012
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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 approved to treat neuropathic pain from postherpetic neuralgia (a complication of shingles), should be expanded to treat neuropathic pain related to HIV, also known as HIV-Associated Neuropathy (HIV-AN). » Read more: NeurogesX (NGSX): Chili Pepper Drug Qutenza
January 12th, 2012
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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 released
7 – ASTX FDA Briefing Documents released
7 – NGSX FDA Briefing Documents released
9 – CTIC Ad-Comm
9 – ASTX Ad-Comm
9 – NGSX Ad-Comm
17- CORT PDUFA
20 – VVUS Briefing Documents released
21 – CHTP FDA Briefing Documents released
22 – VVUS Ad-Comm
23 – CHTP Ad-Comm
26 – CBRX PDUFA
Other Possible Events
ONTY – (Interim Analysis)
ANTH – (Interim Analysis VISTA-16 trial)
VVUS – (EU Decision)
ARNA – (Announcement of an Ad-Comm is needed, without an Ad-Comm the FDA will not approve a weight loss drug. Therefore absence of an Ad-Comm is a good indicator of CRL).
THLD – (PH2 Data)
QCOR (Streetsweeper report)
MAPP – (Ad-Comm notice, company has yet to announce an Ad-Comm, Levadex is an inhalable)
January 10th, 2012
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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 available to patients. It is a hormonal disorder caused by prolonged exposure of the body’s tissues to high levels of the hormone cortisol. » Read more: Corcept (CORT): Mifepristone PDUFA Notes
January 4th, 2012
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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 was disclosed to investors. The company stated that they had resubmitted their NDA to the FDA on 12/27/2011, yet waited and allowed their stock to trade on the market until 1/3/2012 without making this material information available to their investors. » Read more: Arena Pharmaceuticals (ARNA) Conference Call Notes
December 8th, 2011
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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, I’ll list the page numbers so you can verify them for yourself. » Read more: Alexza’s (ALXA) Briefing Documents: Greatest Hits
December 8th, 2011
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Antares Pharmaceutical Wins Anturol Approval
Right now attention is focused on two catalysts for Antares: Anturol’s PDUFA and BioSante’s Libigel efficacy data release which is due out sometime in early December.
» Read more: Antares Pharmaceutical (AIS) Wins Anturol Approval, But Is It Overvalued?
December 2nd, 2011
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Affymax Briefing Documents Prep
So I’m going to highlight some of the concerns/risks that I’m looking for in the Affymax Peginesatide Briefing Documents that are due to be released on Monday morning. I have previously reviewed the drug and I recommend reading that analysis before reading further because this article will be in bullet point format and not an overview of the entire NDA. » Read more: Affymax (AFFY) Briefing Documents Prep
November 23rd, 2011
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FDA has informed me that Transcept’s Intermezzo has been approved. I’ll be the first to admit I was wrong and eat crow on this one. Here is the FDA’s offical press release –> http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm281013.htm
November 22nd, 2011
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Transcept is facing their 3rd PDUFA for their lead product Intermezzo for Middle of the Night Awakenings on November 27, 2011. » Read more: Transcept (TSPT): PDUFA Analysis
November 9th, 2011
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Alimera Sciences (ALIM) Trading Guesstimates
My Opinion
As I outlined in an earlier article, I noted that I think Alimera faces higher odds of receiving a Complete Response Letter for two main reasons: One being that the company, from my perspective, has not adequately addressed the Risk/Benefit tradeoff and the other being that the company is currently conducting a Doctor Utilization study of their lead product Iluvien. » Read more: Alimera Sciences (ALIM): Share Price Target Trading Guesstimates
November 8th, 2011
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Alimera Sciences (ALIM) Iluvien PDUFA Analysis
Alimera Sciences faces a PDUFA on November 12, 2011 for their lead product Iluvien for diabetic macular edema (DME). Iluvien is inserted in the back of the patient’s eye to a placement site that takes advantage of the eye’s natural fluid dynamics to deliver the non-proprietary corticosteroid fluocinolone acetonide (FAc). » Read more: Alimera Sciences (ALIM) Iluvien PDUFA Analysis
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