I estimate 80% odds for approval and 50% odds for approval with no REMS related delay.
This is based on the fact that it was given a priority review, found to be more effective than the existing treatment (Suboxone), has an excellent safety profile, and was recommended for approval by the FDA panel by a wide margin.
Given the epidemic of opiate addiction in America and the excellent results that this solution provides I would be very surprised if the FDA rejected it.
Long and strong with 5,000 shares!
I won't give 100% approval by 4-30-2013,because I can't be certain how quickly the DEA,FDA and Braeburn can have a meeting of the minds and a decision made. I will give 100% to an ultimate positive REMS decision and while I'm ignorant of the mechanics of FDA decision-making,any delay could be as little as a week or two beyond the PDUFA date of 4-30-2013.
Everything that has appeared on the FDA website apart from the Probuphine NDA indicates that the need for opioid dependence treatment using applications other than pills is urgent. Consequently the FDA is motivated to act ASAP.
95 percent approval without REMS delay. I suspect we will get early approval, a week before April 30th. This is a huge unmet medical need that the public is clamoring for.
Sentiment: Strong Buy
I think 70% in April; 95% by July; 100% by March 2014. I also believe Braeburn will do a good job on marketing/launch and the sales will be good. Probuphine will become the gold standard of opium addict treatment. TTNP will hit $3. when approved and over $4. within one year after launch.
You folks know I never predict or guess prices or time approvals,lol but I 'll give it a shot,early approval mid April,all those issues that they say are issues,are non issues,every thing a go,100% approval,most likely before April 30th.,and yes,of cause 25+++pps,please I need this to be kept under 2 bucks till april 12 th,thanks,shorties,bashers.thanks in advance.
Been here for years so I'll play.... I give Probuphine a 100% chance of approval this year, with only a slight possiblity of one or more delays, no more dilution by the company, a possible buy-out and 85% odds the REMS was a non-issue Braeburn resolved with DEA confirmation to FDA within one week of the AdCom (which I attended). It wouldn't surprize me if Probuphine got an early approval but more likely it will happen 4/30.
Remember when guessing to use the following...FDA: "SAFE and EFFECTIVE (science and stats)....PANEL: "SAFE and EFFECTIVE" (2:1, science, stats and recs)....PUBLIC SENTIMENT: DEMANDS ACTION....BODY POLITIC: DEMANDS ACTION....EPIDEMIC versus FDA ruling "who is, by the way, off the hook now for safety and effectiveness, deferring to DEA on REMS and without a single consideration for Probuphine's future profitability"==== APPROVAL=GAME OVER? Not a chance because the product must be marketed and become profitable to be considered a success. Will those investors entering now make money? Some, more than others, provided marketing is a success, or Titan is bought out (not necessarily in that order.) The extent of an investor's success will be weighted by their decisions in the coming 21 trading days. Can there be setbacks? There already have been more of those than one can count. Was the AdCom a positive for Titan given P1, P2, P3a and P3b studies, issues like the July 2011 FDA data requests, HVAC issues on manufacturing, patent via the USPTO decision, overly-dilutive usurious-termed financing deals for on-going operation just to get to the NDA, SB's big-mouthed bad PR, extensive time and precious financial resources allocated to partner acquisition, more lost revenue than can be calculated in delay after delay?Yes, I'd say the outcome of the AdCom was about the most positive event in company history during the past 4 years, seconded by the publication of the JAMA article (which I've heard rumored is due a follow-up shortly). More later.
jodiesandy, in an earlier article written by you you sounded doubtful that the REMS issue would be dealt with by April 30th. What has made you more optimistic? Now your main concern seems to be that if the drug is approved it won't provide much revenue or profit for Titan. I must respectfully disagree as this treatment has blockbuster potential and Titan's partnership with Braeburn still allows it to generate substantial revenues and profits, to say nothing of milestone payments. This treatment could also be used to treat chronic pain and Parkinson's disease. Does the current stock price reflect those possibilities? Not even close.