Track the companies that matter to you. It's FREE! Click one of these fan favorites to get started: Apple; Google; Ford.



Encysive Hears the Voice of Reason

Finally bowing to the inevitable, Encysive Pharmaceuticals (Nasdaq: ENCY  ) announced today that it was planning an additional phase 3 trial to try and bring its lead drug to market in the United States.

Encysive's pulmonary arterial hypertension treatment Thelin has been issued three approvable letters, and also had an appeal of the approvable letters rejected after it first filed a marketing application for the drug back in 2005.

But the U.S. approval of Thelin has been blocked -- despite approvals in many other countries throughout the world -- by the FDA's lack of satisfaction that Encysive has proven the drug's efficacy, and its request for another clinical trial.

After conferring with "external experts," Encysive has also decided to give up on the dispute resolution process over Thelin with the FDA. Instead, it will focus on starting this clinical trial for the drug.

No specifics were given for the trial's start date or size, but Encysive did mention that it would be working with the FDA to finalize the study's protocol. That means it will be another few weeks at the earliest before the trial can begin.

Encysive's other pivotal phase 3 study, Stride-2, was an 18-week study that took 20 months from start to completion. If you count the three or so months that it will take Encysive to put together a marketing submission following the completion of the new study, and the six months minimum that it will take the FDA to review the data if the study is a success (which it should be), that puts Thelin on the market in the U.S. in late 2009 or early 2010, provided there are no bumps along the way.

With all the missteps in its attempts to bring Thelin to the market in the U.S., at least investors can feel comforted that Encysive is finally doing what it should have done after the second approvable letter back in July of 2006. It's too bad that Encysive's delay caused it to lose its U.S. lead over Gilead Sciences' (Nasdaq: GILD  ) Letairis, which gained regulatory approval in June.

Read/Post Comments (0) | Recommend This Article (7)

Comments from our Foolish Readers

Help us keep this a respectfully Foolish area! This is a place for our readers to discuss, debate, and learn more about the Foolish investing topic you read about above. Help us keep it clean and safe. If you believe a comment is abusive or otherwise violates our Fool's Rules, please report it via the Report this Comment Report this Comment icon found on every comment.

Be the first one to comment on this article.

Compare Brokers

Fool Disclosure

Sponsored Links

Leaked: Apple's Next Smart Device
(Warning, it may shock you)
The secret is out... experts are predicting 458 million of these types of devices will be sold per year. 1 hyper-growth company stands to rake in maximum profit - and it's NOT Apple. Show me Apple's new smart gizmo!

DocumentId: 537319, ~/Articles/ArticleHandler.aspx, 10/24/2016 6:13:42 PM

Report This Comment

Use this area to report a comment that you believe is in violation of the community guidelines. Our team will review the entry and take any appropriate action.

Sending report...

Today's Market

updated Moments ago Sponsored by:
DOW 18,223.03 77.32 0.43%
S&P 500 2,151.33 10.17 0.47%
NASD 5,309.83 52.43 1.00%

Create My Watchlist

Go to My Watchlist

You don't seem to be following any stocks yet!

Better investing starts with a watchlist. Now you can create a personalized watchlist and get immediate access to the personalized information you need to make successful investing decisions.

Data delayed up to 5 minutes

Related Tickers

10/24/2016 4:00 PM
GILD $74.15 Down -0.14 -0.19%
Gilead Sciences CAPS Rating: *****