posted
Might want to get in this one now...FDA decision here on Thelin on April 15/18 sometime around then. I bet it gets FDA approved this time, which will be huge! Bargain prices here.
-------------------- Disclaimer: Not accountable for anything I say Posts: 6266 | Registered: Jun 2004
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posted
scottfest..hard to tell...been up a lot the past few days, but FDA approval may be right around the corner. I got in at $3.24 and $3.25 this morning. With FDA approval this doubles or more..but I think this runs well until FDA decision.
-------------------- Disclaimer: Not accountable for anything I say Posts: 6266 | Registered: Jun 2004
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posted
I thought the date was June 15th, got a link showing otherwise?
HOUSTON, Dec. 28, 2006 (PRIME NEWSWIRE) -- Encysive Pharmaceuticals (Nasdaq:ENCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company's complete response to the July 24, 2006 approvable letter regarding its New Drug Application (NDA) for THELIN(tm) (sitaxsentan sodium) 100 mg tablets. The FDA has designated the review as a Class 2 resubmission and issued a new Prescription Drug User Fee Act (PDUFA) target action date of June 15, 2007.
-------------------- ......in Psychiatry circles it's known as a "warning sign" Posts: 1736 | From: Saint Louis | Registered: Jul 2005
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My mistake, bad rumor going around about fda panel vote on that date, which I do not believe is true. Regardless with the tremendous pipeline this company has, it is obvious its undervalued.
Thelin is a billion dollar drug, and tcb-3711 is even better!
-------------------- Disclaimer: Not accountable for anything I say Posts: 6266 | Registered: Jun 2004
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posted
Am not versed in these (although I posted one tonight), but if you follow these plays, isn't it fairly easy to guage dates for rulings/hearings/events, etc?
quote:Originally posted by T e x: Am not versed in these (although I posted one tonight), but if you follow these plays, isn't it fairly easy to guage dates for rulings/hearings/events, etc?
Yes it normally is, but sometimes not as easy as you think. FDA runs on a weird schedule, not to mention since managing my dad's IRA account, bio-firms have become new to me. But thats why ive posted so many lately, risk vs reward with the ones that trade near cash value are tremendous.
-------------------- Disclaimer: Not accountable for anything I say Posts: 6266 | Registered: Jun 2004
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posted
Was looking for 4 buddy, but I saw the market sentiment this morning, and sometimes you just want to take the profit. I'm quite the pumper lol when >50% of my picks are winners lol
-------------------- Disclaimer: Not accountable for anything I say Posts: 6266 | Registered: Jun 2004
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quote:Originally posted by stocktrader22: My mistake, bad rumor going around about fda panel vote on that date, which I do not believe is true. Regardless with the tremendous pipeline this company has, it is obvious its undervalued.
Thelin is a billion dollar drug, and tcb-3711 is even better!
No prob, I know where the rumor came from, pretty obvious.
-------------------- ......in Psychiatry circles it's known as a "warning sign" Posts: 1736 | From: Saint Louis | Registered: Jul 2005
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posted
to bad there wasnt that fda decision anymore than it may have turned out like DNDN, it would have been nice
Posts: 50 | Registered: Oct 2006
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posted
HOUSTON, April 16, 2007 (PRIME NEWSWIRE) -- Encysive Pharmaceuticals (ENCY) today announced the commercial availability of THELIN(r)(1) (sitaxentan sodium(2)) 100 mg tablets in the Netherlands for the treatment of pulmonary arterial hypertension (PAH). The Company received European Union marketing authorization for THELIN from the European Commission in August 2006. THELIN is the first selective endothelin A receptor antagonist and the first once-daily oral treatment available for patients with PAH.
THELIN is indicated for improving exercise capacity in PAH patients classified as World Health Organization (WHO) functional class III. Efficacy has been shown in primary pulmonary hypertension(3) and pulmonary hypertension associated with connective tissue disease (CTD).
"As a once-daily oral therapy, THELIN may provide PAH patients with effective symptom management in a convenient, non-invasive route of administration," said Anco Boonstra, M.D., Ph.D., pulmonologist, Vrije Universiteit Medical Center, Amsterdam. "THELIN is a welcome new treatment option for patients with primary disease and also those with CTD-related PAH, where THELIN has demonstrated a therapeutic benefit."
The European Commission's centralized licensing procedure permits Encysive to market THELIN in all 27 member states of the European Union. THELIN has been launched in three member states to date, and will be commercialized in successive EU countries as local government approval for reimbursement is obtained.
- Nice movement this morning.
Posts: 124 | Registered: Oct 2006
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