Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : Encysive Pharmaceuticals (ENCY) -- Ignore unavailable to you. Want to Upgrade?

To: rkrw who wrote (150)	12/14/2006 2:32:49 PM
From: tuck	Respond to of 205

3rd and inches from goal, which is not a bad place to be. Should we get sacked, our field goal will cost several years and tens of millions of dollars, but we have a lot of confidence in our front line in this 3rd and inches situation, not a bad place to be . . . Cheers, Tuck

To: rkrw who wrote (150)	12/14/2006 2:43:08 PM
From: bio_kruncher	Respond to of 205

I think ENCY issue is likely same as POZN. my guess is FDA usually asks for a safety update. Typically updating integrated safety summary tables with clinical data acquired since data cut-off for NDA filing. Companies may just submit updated summary tables which would require agency to spend a lot of time to determine what had changed since previous filing. Best way is to provide in a manner that clearly shows what has changed to minimize FDA review time. Due to resource constraints, the FDA has in past 1-2 years gotten much stricter about what they will accept. If it is any extra work for them they will refuse things that they had previously accepted.

To: rkrw who wrote (150)	9/24/2007 8:35:05 AM
From: rkrw	Respond to of 205

If ency/Given had started this trial when the fda first requested, would they be finished by now? Press Release Source: Encysive Pharmaceuticals Inc. Encysive Pharmaceuticals to Conduct Phase III Study With Thelin (Sitaxsentan Sodium) in Pulmonary Arterial Hypertension Monday September 24, 7:00 am ET HOUSTON, Sept. 24, 2007 (PRIME NEWSWIRE) -- Encysive Pharmaceuticals Inc. (NasdaqGM:ENCY - News) today announced that the Company will move forward with plans to conduct an additional Phase III study evaluating Thelin(tm) (sitaxsentan sodium) in patients with Pulmonary Arterial Hypertension (PAH). The company has been discussing possible protocols for the trial, to be called STRIDE 5, with its Scientific Advisory Board and other experts. The company will now work with the FDA to finalize the protocol. After the Company has concluded its protocol discussions with the FDA, it will announce the details of the study, including timing and the number of patients. Encysive believes it had successfully addressed all of the questions raised by the U.S. FDA in its New Drug Application (NDA) for Thelin in PAH. However, the Company has concluded after consulting with external experts that the best path forward for commercializing Thelin in the U.S. is to conduct an additional Phase III study. As a result, Encysive will not continue to pursue the formal dispute resolution process with the FDA. Background Following receipt of the June 15, 2007 ``approvable'' letter from the FDA, the Company filed a request for formal dispute resolution with the FDA over its decision. Dispute resolution is a process where companies can challenge regulatory decisions by bringing the dispute to the attention of FDA supervisors. In September of 2007 the Agency replied that, while the data in the NDA are suggestive of the effectiveness of Thelin, it did not provide the substantial evidence of effectiveness needed for approval, and recommended an additional Phase III trial as the best path forward.