. . . read the last line a couple of times -- slowly -- if it doesn't sink in the first time: SAN DIEGO, Nov. 25, 2013 /PRNewswire/ -- Orexigen Therapeutics, Inc. (Nasdaq: OREX) today announced successful results of the interim analysis of the Light Study. Based on these results, the Company will resubmit the Contrave® New Drug Application (NDA) to the United States Food and Drug Administration (FDA) in the next few weeks with potential approval by June 2014.
"The interim analysis of the Light Study clearly achieved the goal set by the FDA," said Michael Narachi, CEO of Orexigen. "The resubmission will contain an unprecedented amount of cardiovascular outcomes data for an obesity therapeutic, and we are confident these data will support a favorable benefit:risk assessment for Contrave."
The FDA previously agreed that if the interim analysis meets the specified criteria to exclude cardiovascular risk, Contrave could be approved." . . .
. . . so long as all of OREX's "tricks" are written into the Special Protocol Assessment, it should be no problem . . . but feel free, m1, to quote any section of the SPA that would support your assertion . . . actually, I think you should be saving your criticism for ARNA, which, year-to-date, has been a monumental flop as an investment . . . and I say that as an investor in both ARNA and OREX . . .
. . . in phase three trials, ab, Contrave outperformed belviq as a weight-loss drug, and while OREX's balance sheet today is not as strong as arna's, it likely has far greater potential as an investment due to a lower market cap, and a better deal with a marketing partner that's three-times the size of arna's -- plus, with so small an organization, OREX is more likely a quick buyout candidate . . . on the pharmacology side, OREX's proprietary extended-release formulation will be all that's necessary to keep Contrave exclusive, and having its long-term side effects already well-known will be real advantage in gaining European approval . . .
. . . still looking to sell my ARNA shares so I can buy more OREX . . .
. . . so you think today's announcement means nothing, rp? . . . Mr. Market disagrees . . . OREX's share price was up more than 9% on nearly 15-times normal volume, and it was one of only a half-dozen stocks featured on the "Nightly Business Report" . . . you are right, however, on one point . . . Contrave is not yet approved -- if and when it is, OREX's market cap could very well exceed that of ARNA -- I'll assume you can do the math on the share price . . .
. . . repeating a falsehood -- no matter how many times you do it -- doesn't make it true . . . I did not call you a fool, 2195 -- perhaps "foolish," but that's not the same thing (another English language subtlety) . . . regarding your "short" in 2013, I think the term you were looking for was "over-bought" -- not over-sold . . . and the financial news services peg the 52-week high for OREX at $7.84 -- not "mid-9s" . . . unless, perhaps, you were trading in a currency other than the U.S. dollar? . . . good luck with your . . . pursuits . . .
. . . that's not what's important, m1 . . . here's what is -- according to MF's George Budwell: ". . . Orexigen is in some ways in an enviable position by being behind Arena and VIVUS in launching an anti-obesity drug. By being two years behind its competitors, Orexigen has allowed Arena and VIVUS to do all of the heavy lifting in terms of altering the obesity med paradigm. To take advantage of their position, Orexigen and marketing partner Takeda are planning on rolling out a dramatically higher level of marketing resources than their competitors, if Contrave is indeed approved in the coming year." . . .
. . . according to MF's George Budwell: "Orexigen is in some ways in an enviable position by being behind Arena and VIVUS in launching an anti-obesity drug. By being two years behind its competitors, Orexigen has allowed Arena and VIVUS to do all of the heavy lifting in terms of altering the obesity med paradigm. To take advantage of their position, Orexigen and marketing partner Takeda are planning on rolling out a dramatically higher level of marketing resources than their competitors, if Contrave is indeed approved in the coming year." . . .
. . . your memory is apparently as faulty as your trading . . . I don't refer to people as fools; however, I think I do recall speculating that you were possibly not an investor at all, but a student studying English as a second language and looking to engage people anonymously on the internet . . . well, in any case, best of luck with your studies . . .
. . . "In addition to a possible U.S. approval by June 2014, Orexigen believes Contrave could be approved in Europe before the end of 2014. European regulators have already rejected Vivus' and Arena' respective obesity pills." . . . all you really need to know . . .
. . . face it -- ARNA's a flop so far . . . and it's OREX that's likely to get first approval in the European Union . . . but hey, you knew that . . .
. . . jeez . . . lot of anger there, raphie . . . calm down -- it's only money . . .
. . . are you maybe an OREX short/ARNA pumper? YES . . . are your statements detached from reality? YES . . . are you a funny guy? . . . UNQUESTIONABLY . . .