quote:Originally posted by Repoman75: Maybe, but if the FDA denies approval, the PPS will get CRUSHED short term at these levels.
Agreed..but i think 3rd time is a charm...also keep in mind..this stock is a good recover. Solid company IMO and if this drug fails there are always more to look forward to in the future. With any FDA approval news I would expect to see $10-$12 short term..and a gap to $8 that morning.
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Keep in mind ENCY about a month ago said it should be about a month before FDA come to their decision. Like Motley fool says it could be any day now or up to 5 months, but i really do think the drug will be approved this time, and want to be in for the gap up
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Now of course this isn't the approval for the main drug they are trying to market...but this is definitely an up and coming drug and looks very good now that they got FDA approval to continue
TBC3711 (Phase 1) Waiting in the wings for sitaxsentan to complete its Phase 3 trial, is TBC3711, an endothelin A antagonist that showed excellent kinetics in Phase 1 studies. Based on the positive data we've received for sitaxsentan, our first endothelin A antagonist, we believe TBC3711 holds promise as a next generation compound
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quote:Originally posted by Repoman75: Good flip, but the mother of all approvals is still waiting.
Repo, I like how you said it in the other ENCY thread as well: "They submitted their FDA approval letter.... in 30 days, this stock goes to $10 or $2... gamble time."
I was waiting for this to possibly get to 5.85range before putting my chips on the table. That didn't happen. Looks like I'll be sitting out on this hand. Anyone want to do a side bet on the FDA approval? - I'll bet you 5bucks they get it.
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Dec 14 (Reuters) - Encysive Pharmaceuticals Inc. (ENCY.O: Quote, Profile , Research) said the U.S. Food and Drug Administration has found its response to a July "approvable letter", for its experimental treatment Thelin incomplete.
The Houston, Texas-based company said it expects to provide the requested information related to the treatment, which is for an often-fatal lung condition, within several days, and is hopeful this will resolve any remaining questions. (Reporting by Sweta Singh in Bangalore)
-------------------- Stick with Repo's plan in '07 - FRPT/DKAM!
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Well what'dya know......today is day 30 (business days). If the response was "incomplete", I just dont see why it took the FDA so long to say so.
Approval is still a possibility and thus the tank we're seeing is "mild" in my opinion. It will be interesting to see who's buying between now and when the FDA reports with the additional info ENCY submits. It's gamblin time and my roll of the dice says "pray".
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FDA Accepts Encysive's Complete Response to THELIN New Drug Application Thursday December 28, 1:53 pm ET Conference Call Scheduled for Today at 2:15 p.m. Eastern Time
HOUSTON, Dec. 28, 2006 (PRIME NEWSWIRE) -- Encysive Pharmaceuticals (NASDAQ:ENCY - News) 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.
THELIN is currently being evaluated by the FDA as a potential new oral treatment for patients with pulmonary arterial hypertension (PAH).
The Company will work with the FDA to schedule a meeting as soon as possible in an effort to clarify the situation and move the application forward.
Encysive is currently in the process of commercializing THELIN 100 mg in the European Union, following the August 2006 receipt of marketing authorization from the European Commission. To date, THELIN has been launched in the United Kingdom and Germany.
-------------------- Stick with Repo's plan in '07 - FRPT/DKAM!
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Ency's THELIN is approved through out Europe and Australia we should see some revenue stream I assume about 60% will be coming from overseas. FDA already approved the NDA so its funny whats going on , but I may wait till June if I have to and in the mean time load up.
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