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Up the Heat!

Tuesday, November 9, 2010. The FDA Gets Lost on its "Critical Path". I have to admit it – even I am a little impressed with the continued good results from Qnexa’s second year trial, Sequel. Subjects generally did not lose more weight, but they did an impressive job of sustaining the weight loss results of the one-year Equip trial. And apparently. They did this without further complications of safety issues – but I do have to stress apparently. Since we have only Vivus’ say-so to go by. More discovery an...

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Up the Heat! | uptheheat.blogspot.com Reviews

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Tuesday, November 9, 2010. The FDA Gets Lost on its Critical Path. I have to admit it – even I am a little impressed with the continued good results from Qnexa’s second year trial, Sequel. Subjects generally did not lose more weight, but they did an impressive job of sustaining the weight loss results of the one-year Equip trial. And apparently. They did this without further complications of safety issues – but I do have to stress apparently. Since we have only Vivus’ say-so to go by. More discovery an...

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5 dramatically more effective

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Up the Heat! | uptheheat.blogspot.com Reviews

https://uptheheat.blogspot.com

Tuesday, November 9, 2010. The FDA Gets Lost on its "Critical Path". I have to admit it – even I am a little impressed with the continued good results from Qnexa’s second year trial, Sequel. Subjects generally did not lose more weight, but they did an impressive job of sustaining the weight loss results of the one-year Equip trial. And apparently. They did this without further complications of safety issues – but I do have to stress apparently. Since we have only Vivus’ say-so to go by. More discovery an...

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uptheheat.blogspot.com

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Up the Heat!: The FDA Gets Lost on its "Critical Path"

http://uptheheat.blogspot.com/2010/11/fda-gets-lost-on-its-critical-path_09.html

Tuesday, November 9, 2010. The FDA Gets Lost on its "Critical Path". I have to admit it – even I am a little impressed with the continued good results from Qnexa’s second year trial, Sequel. Subjects generally did not lose more weight, but they did an impressive job of sustaining the weight loss results of the one-year Equip trial. And apparently. They did this without further complications of safety issues – but I do have to stress apparently. Since we have only Vivus’ say-so to go by. More discovery an...

2

Up the Heat!: Dr. Daniel's Letter to the FDA on tumor data

http://uptheheat.blogspot.com/p/dr-daniels-letter-to-fda-on-tumor-data.html

Dr Daniel's Letter to the FDA on tumor data. October 6, 2010. Margaret Hamburg, M.D. Commissioner, Food and Drug Administration. 10903 New Hampshire Ave. Dear Dr. Hamburg,. Table 3: Multiples of clinical exposure to lorcaserin achieved in 2yr rat study -. 104-week Rat Carcinogenicity Study. Exposure multiples calculated as AUC exposure in rats divided by average AUC exposure of the clinical dose of lorcaserin, 10mg BID, 1.02 ug*h/ml AUC. The interpretation of the carcinogenicity data in the FDA briefing ...

3

Up the Heat!: Lorcaserin's Efficacy -- Maligned & Misunderstood

http://uptheheat.blogspot.com/p/lorcaserins-efficacy-maligned.html

Lorcaserin's Efficacy - Maligned and Misunderstood. Why is the efficacy of Lorqess so maligned and so misunderstood? Before Qnexa produced a larger degree of mean weight loss, the Lorqess results would have appeared right in line with all other recent approvals and candidates. So why, all of a sudden, is this degree of mean weight loss no longer acceptable? The FDA has two alternative guidelines for demonstrating efficacy in a weight loss agent. The first is easy and intuitive to understand. It works mod...

4

Up the Heat!: FDA Bias on Lorcaserin

http://uptheheat.blogspot.com/2010/11/fda-bias-on-lorcaserin.html

Wednesday, November 3, 2010. FDA Bias on Lorcaserin. To be valvular heart disease, and accordingly there were 3 cardiologist on the panel. The omission of a clinical cancer expert guaranteed that this cancer risk would not be addressed adequately during the meeting. This left a huge, scary cloud of question marks in the minds of all the panelists, which hung over the entire meeting. Criteria that FDA Guidelines provide to indicate evidence of sufficient efficacy. Neither did any of these other agents!

5

Up the Heat!: Lorcaserin Advisory Panel -- COMPLETE TRANSCRIPT!

http://uptheheat.blogspot.com/p/lorcaserin-advisory-panel-transcript.html

Lorcaserin Advisory Panel - COMPLETE TRANSCRIPT! The complete panel transcript. COLMAN: (00:07 – 00:16). Thank you. I’d like to welcome back all the folks that were here yesterday, and also welcome those of you who are joining us for the first time. Um, do you want to go over the questions? DR GARY WILLIAMS PRESENSTATION OF CARCINOGENICITY. 00:22 – 00: 41. DR WILLIAM SHANAHAN PRESENTATIONON CLINICAL EFFICACY. 00:41 – 01:00. DR CHRISTINE ANDERSON PRESENTATION ON LORCASERIN SAFETY. 01:01 – 01:29. DR KAUL (...

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arenadeepcapture.blogspot.com

ARNA Investors: November 2010

http://arenadeepcapture.blogspot.com/2010_11_01_archive.html

Arena Pharmaceuticals is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral drugs that target G protein-coupled receptors, or GPCRs, in four major therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic diseases. Thursday, November 25, 2010. Criminal investigations chief resigns, things are changing at FDA. Story from CNBC, written by AP. Please read the full story on CNBC. Link: http:/ www.cnbc.com/id/40341826. Earlier thi...

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Up the Heat!

Tuesday, November 9, 2010. The FDA Gets Lost on its "Critical Path". I have to admit it – even I am a little impressed with the continued good results from Qnexa’s second year trial, Sequel. Subjects generally did not lose more weight, but they did an impressive job of sustaining the weight loss results of the one-year Equip trial. And apparently. They did this without further complications of safety issues – but I do have to stress apparently. Since we have only Vivus’ say-so to go by. More discovery an...

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