AI
Sunday, April 04, 2010 2:57:35 AM
Stealth DD w/POZN ($9.74)…LETS LOOK AT SOME KEY POINTS MADE FROM A RECENT ZACK’S ARTICLE & DISCUSS THEIR validity & legitimacy pts for believing there will be an approval of VIMOVO on April 30th. What I will do in each statement is provide backing & proof for their reasoning by providing slides and clinical data that support their 5 reasons for Vimovo approval below. The overwhelming evidence supports that VIMOVO should be approved on April 30th based on the clinical data presented below to validate key points made on reasons for approval!
Zacks….Reasons why we believe Vimovo will be approved on April 30, 2010:
http://www.zacks.com/stock/news/31222/Bullish+on+Pozen+-+Analyst+Blog
1. Esomeprazole (approved in a delayed release form as Nexium) is already approved for combination use with naproxen (an approved OTC drug at lower doses).
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021153s031,021957s003,022101s001lbl.pdf
2. Phase III program met primary endpoint and was conducted under a special protocol assessment (SPA).
http://en.wikipedia.org/wiki/FDA_Special_Protocol_Assessment
The clinical protocols for phase 3 trials can relate to efficacy claims that will be part of an original new drug application (NDA) or biologics license application (BLA) or that will be part of an efficacy supplement to an approved NDA or BLA.
3. Significant unmet medical need for patients given the withdrawal of Vioxx and Bextra.
http://www.pozen.com/product/posters/PN400-301%20302%20ACR%20poster_final.pdf
2009 American College of Rheumatology/ARHP Annual Scientific Meeting - Philadelphia (October 2009)
4. ACC & ACG both recommend gastro-protectant for patients taking daily NSAIDs.
5. FDA compared benchmark NSAID safety to naproxen back during the Cox-II issues in 2005. Vioxx was removed from the market and many on the FDA felt as though naproxen + PPI was a safer alternative.
Zacks….Reasons why we believe Vimovo will be approved on April 30, 2010:
http://www.zacks.com/stock/news/31222/Bullish+on+Pozen+-+Analyst+Blog
1. Esomeprazole (approved in a delayed release form as Nexium) is already approved for combination use with naproxen (an approved OTC drug at lower doses).
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021153s031,021957s003,022101s001lbl.pdf
2. Phase III program met primary endpoint and was conducted under a special protocol assessment (SPA).
http://en.wikipedia.org/wiki/FDA_Special_Protocol_Assessment
The clinical protocols for phase 3 trials can relate to efficacy claims that will be part of an original new drug application (NDA) or biologics license application (BLA) or that will be part of an efficacy supplement to an approved NDA or BLA.
3. Significant unmet medical need for patients given the withdrawal of Vioxx and Bextra.
http://www.pozen.com/product/posters/PN400-301%20302%20ACR%20poster_final.pdf
2009 American College of Rheumatology/ARHP Annual Scientific Meeting - Philadelphia (October 2009)
4. ACC & ACG both recommend gastro-protectant for patients taking daily NSAIDs.
5. FDA compared benchmark NSAID safety to naproxen back during the Cox-II issues in 2005. Vioxx was removed from the market and many on the FDA felt as though naproxen + PPI was a safer alternative.
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