. . . I can see why it might look crazy to you, sc . . . particularly if you didn't read the whole article or if you don't understand the particulars of the Special Protocol Assessment that OREX has with the FDA . . .
. . . "The FDA seems highly receptive to getting Contrave on the market. In an unusual move, it's allowing Orexigen to resubmit its application without the data from the safety trial, thus starting the six-month review clock. . . . It's almost like the FDA feels bad for making Orexigen run a large trial that turned out to show the agency was worried for no reason." . . . says it all . . .
. . . but you ignore the best parts, llb . . . "The FDA seems highly receptive to getting Contrave on the market. In an unusual move, it's allowing Orexigen to resubmit its application without the data from the safety trial, thus starting the six-month review clock. . . . It's almost like the FDA feels bad for making Orexigen run a large trial that turned out to show the agency was worried for no reason." . . . says it all . . .
. . . you're not paying attentiion, pa . . . the areniacs, apparently, did not know it was coming . . . that is, if you believe the garbage they post here every day . . .
. . . so what, exactly, was the reason given for ARNA pulling its application in Europe? . . .
. . . agree, ua . . . and WS likes management teams that deliver on their promises . . . regarding NAVB
and GERN, I read the SA article on the pair and looked at a few fundamentals . . . NAVB looks like the safer shot, but maybe with far less potential for share appreciation than GERN -- but I didn't see anything that would preclude me from taking an initial small position in either . . . others to consider if you have a taste for risk and want to buy a few shares on a pullback: ACAD, CHTP and NVAX . . . good luck . . .
. . . "projected to produce, by many accounts," . . . if that's what you want to believe, load the truck -- looks like it's on sale again today . . . good luck . . .
""Narachi continued: "This resubmission sets in motion the first of four potential key catalysts in 2014. With the successful Light Study interim analysis, we are confident in the prospect for approvals next year in the United States and in Europe. If Contrave is approved, we look forward to a well-executed U.S. launch by Takeda. Additionally, we anticipate making progress next year in our discussions with potential partners for Contrave for territories outside North America."" . . . says it all . . .
. . . I don't think your CELG example -- or the timeline -- makes much sense, since multiple myeloma and myelodysplastic syndrome (MDS) are two different indications . . . as I recall, Euro regulators were concerned about approving Revlimid for front-line use in multiple myeloma due to its possible connection to second primary malignancies (SPMs) . . . CELG's ability now to resubmit its application for frontline MM is only due to the maturity of its large, long-running MM-020 study, wherein three arms -- Revlimid; Revlimid, dexamethazone; thalidomide, melphalan, prednisone -- conclusively show that the SPM problems were unrelated to Revlimid . . . I have no idea what ARNA is planning do to mitigate Euro concerns . . . for that matter, what are they, exactly? . . .
. . . more important for the kids, DMD has been targeted by genetic engineers who are looking to cure it, not just treat the symptoms . . . June 4 headline in ScienceDaily, “Genetic Editing Shows Promise in Duchenne Muscular Dystrophy” . . . story says Duke biomed engineers “have been able to repair a defect responsible for one of the most common inherited disorders, Duchenne muscular dystrophy, in cell samples from Duchenne patients.” And they’ve done it, apparently, by overriding the faulty gene . . . genetic engineering, without doubt, will revolutionize the pharma industry . . . Bristol Myers, Novartis, Roche (Genentech), and many other BPs are already making the transition . . .
. . . a market cap of $8.75 billion for half ownership (?) in a drug with relatively small indications could be one reason . . .
. . . still looking to dump my arna shares so I can buy more OREX . . . but, then, isn't everyone? . . .
. . . actually, ua, I think the FDA first has to "accept" the resubmission before they will schedule a PDUFA . . . if they view it as incomplete, for instance, they could send it back to OREX for more work . . . though a very unlikely scenario at this stage . . . .
. . . from your desperate response on the merits of ARNA, s&tc, I can only surmise that you must be in over your head . . . ARNA has to deliver significantly improved results in both revenue and earnings growth if it expects any additional share price appreciation . . . OREX does not . . . it simply has to file on time with the FDA -- as it already has with European regulators -- and, as the PDUFA date approaches, its market cap will likely climb toward parity with ARNA. . . the smart option at that point would be to take profit and move on . . .
. . . you're not paying attention, of&t . . . as I stated earlier, I foolishly bought ARNA near $8, thinking that there would be a launch rally after approval ($10-plus) and that I could quickly raise cash to buy more OREX . . . since my purchase, the spread between OREX and ARNA has only narrowed . . . so I wait -- owning ARNA as little more than a hedge -- though it doesn't change my assessment of ARNA as significantly overvalued on the fundamentals . . . good luck, by the way, with your junior college psych course . . .