non inferiority should be a slam dunk and statistically significance might be accomplished at the 8mg buprenorphine level-this will be a plus for probuphine-
nothing will speed this up quest its a very slow process however approval chances much better now in 2015-2016
If you bought at 3.30 and held after panel meeting you only expect CHTP to go to low 6.00's if/when approved,WHY didnt you sell on FEB 11 OR FEB 12th when during day CHTP peaked to the 5.40's?
OF course 6.00+ is better than 5.40 but there is never a guarantee of approval and no guarantee share price will be 6.00+ after approval-that depends possibly on the labeling-
You made an error as we are all at sometimes victim of greed...
PLease tell me how do you figure UNIS will never go under 11mil per quarter again? Are you expecting upfront milestone fees every quarter from multiple companies?
There is just no way of knowing this as fact-
Accounting methods are a very trick,manipulative job-not sure, but actual product sales revenues might have gone down 2mil this quarter and the upfront milestone fees is what caused the majority of their reported 10.8mil in customer receipts-
Next contract worth 200million first year alone? you are a sick puppy my dear, a real sick, lying puppy
UNIS will be happy to get 20million upfront on next deal, 200mil is a dream,.
Braeburn owns 85+ percent of future royalties-really no major need to buyout Titan-
If anything would happen that would most likely occur post approval in 2-3 years.
jewish investor? zei ga zunt'
CHRISTIAN investor you are? You mean you are a Chrisian gambler in stocks-stock investing=gambling
timohy 6:10 hebrews 1:35 mahew 6:24 hypocrite dont ever use religion for gambling-investing purposes you hypocrite lol
My experience,upgrades are a bunch of B-S for majority of stocks as many of analyst upgrades are the managing partner for a company when they decide to sell stock and dilute shares.Upgrades can rarely be trusted
i said yesterday this will be the biggest hurdle-the integrity of trial and results and was it in any possible way compromised
There is also Shire's Midodrine trial results which are to be announced mid year-not sure how it plays into Northera approval thinking but the panel might want results pre approval not post approval on this new trial chelsea just commenced--
This is very difficult to hypothesize what will happen tuesday--
There is a major issue that needs to be addressed to the favorable liking of the panel-
FDA notes say the integrity of the trial and results might have been compromised-
THat is a very serious comment that wont go past the panel without chelsea needing to explain trial protocol and the large number of dropouts and missing followup info on many patients-
IF panel believes trial not well run and results possibly compromised,then no way this time they vote majority yes-
IF panel believes in the integrity of the trial and the results,then this has a good chance for approval-
this is a vERY tough call...
THere are cases where FDA documents are pro-approval in their language and if that happens for Northera,you can bet a unanimous or substantial positive panel vote would follow suit.
FDA documents are usually geared towards a negative tone,thats just the normal protocol but that is not always indicative of how a panel or the FDA would eventually vote.FDA seeks panel members guidance on some difficult questions and decisions they have to make-ANy negative tone in documents shorts always try to spin things their way-FDA already has a general idea on approval or not and seeks panel members input to persuade them more either way,for a yes or no approval.