AI
Thursday, April 22, 2010 2:38:34 AM
POZN ($10.78) and their Progress with the PA Franchise
Vimovo is already under an SPA (special protocol assessment) w/ the FDA. PA32540 is also under an SPA. Obviously the FDA likes the way that Pozen is advancing products that have already been on the market as they try to make them more efficacious & safer. The obvious “strong” ties and relationship with the FDA really bodes well for Vimovo. With Treximet, Pozen did not have an SPA and thus the product received a complete response letter. Treximet later got approved but Pozen learned their lesson and the FDA seems to be a valuable partner moving forward in the development of their trial. This way Pozen does not make mistakes, as other companies have done, and they know what the FDA requires prior to approval. The FDA will make sure with the SPA! Investors do not realize the value of an SPA for a drug company.
Vimovo is already under an SPA (special protocol assessment) w/ the FDA. PA32540 is also under an SPA. Obviously the FDA likes the way that Pozen is advancing products that have already been on the market as they try to make them more efficacious & safer. The obvious “strong” ties and relationship with the FDA really bodes well for Vimovo. With Treximet, Pozen did not have an SPA and thus the product received a complete response letter. Treximet later got approved but Pozen learned their lesson and the FDA seems to be a valuable partner moving forward in the development of their trial. This way Pozen does not make mistakes, as other companies have done, and they know what the FDA requires prior to approval. The FDA will make sure with the SPA! Investors do not realize the value of an SPA for a drug company.
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