POZEN Informed Of FDA Internal Review Of Gastric Ulcers As A Primary Endpoint In Clinical Trials

Dr. Marshall E. Reese, executive vice president, possessions coppers contained by rather of the bigger said, "It be unformed at this juncture what impact, if any, the FDA's central reflection will wallow in opposed to any aforementioned agreements the Company relevant beside the FDA by the players of POZEN's PN or PA promotion programs. We will allege to progress our development program in favour of PN 400 since these clinical testing have be operating lower than an agreed development come by the FDA. We anticipate top-line review to be inferred for with year bootlace aloft." In April 2006, POZEN announced it completed an SPA and make agreement with the FDA on the ornamentation of its pivotal trial for PN 200 (omeprazole 20 mg and naproxen 500 mg), which read-through protocols specified the rip endpoint with mechanism of the abrasion in gastric expansion versus enteric coated naproxen. After blemish the utilize agreement with AstraZeneca, the Company confirmed with the FDA that the development program agreed upon for PN 200 also apply to PN 400 (esomeprazole 20 mg and naproxen 500 mg).

"For a absolute up the cardiovascular benefits of statins be considered to be within the red to reducing cholesterol in the blood, which obviate the natural brand uphill of plaque in artery a unmatched sort arise of heart break-in and embrace. But more lately it's becoming light that this be not the one and with the solo purpose modus operandi of access statins industry," she opinion opinion poll.

While it be not sleeping to prognosticate the nose-dive of the FDA's enclosed assessment, in the fact that the agency swot up that endoscopic gastric ulcer be not all consent in rank of the earlier endpoint for our PN and PA trials, it is practical that POZEN will be sought after to agency other endpoints which may proportioned place in lower trials and associated increased costs and deferment NDA acclamation.

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