Replies to post #14 on Furiex Pharmaceuticals Inc (FURX)

[stocktrader001]

they got a CRL (denied) the stock is trading under 15.00$ right now.

Furiex Confirms Takeda's Receipt of Complete Response Letter from the FDA for Alogliptin and Fixed-Dose Combination Alogliptin and Pioglitazone

MORRISVILLE, N.C., Apr 26, 2012 (BUSINESS WIRE) -- Furiex Pharmaceuticals, Inc. FURX -6.09% today confirmed that Takeda Pharmaceutical Company Limited issued a news release reporting that Takeda has received a complete response letter from the U.S. Food and Drug Administration (FDA) regarding its new drug applications (NDAs) for alogliptin, and the fixed-dose combination therapy alogliptin and pioglitazone.

Takeda recently provided post-marketing data from outside the U.S. and has been in discussions with the FDA. The FDA has requested additional data, which Takeda believes it can supply from post-marketing data from outside the U.S., as well as data from its ongoing clinical trial program.

Takeda intends to immediately request a meeting with the FDA to determine the appropriate next steps and is committed to addressing outstanding issues.

"We are disappointed with the FDA decision," said June Almenoff, M.D., Ph.D., president and chief medical officer of Furiex. "Our partner Takeda has extensive Phase III data, including interim findings from a cardiovascular outcomes trial and we remain confident in the future potential of alogliptin and alogliptin/pioglitazone for the treatment of type 2 diabetes."

Currently, Furiex receives royalty payments from Takeda for the sale of these alogliptin products, trade names NESINA(R) and LIOVEL(R), in Japan.

About Type 2 Diabetes

Type 2 diabetes is the most common form of diabetes and has reached epidemic proportions globally. More than 23 million Americans currently live with the disease. Type 2 diabetes is a progressive and chronic condition, and patients should work with a health care professional to manage and monitor their disease. In addition to diet and exercise, patients often need to take multiple medications to help manage blood glucose. The global health care expenditures to treat and prevent diabetes and its complications were estimated at $376 billion in 2010. By 2030, this number is projected to exceed $490 billion

http://www.marketwatch.com/story/furiex-confirms-takedas-receipt-of-complete-response-letter-from-the-fda-for-alogliptin-and-fixed-dose-combination-alogliptin-and-pioglitazone-2012-04-26