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  • No Chance Of A December Rate Hike  [View article]
    exactly. The want to have room to cut, should they need to. Japan did the same.
    Nov 14, 2015. 10:38 AM | Likes Like |Link to Comment
  • No Chance Of A December Rate Hike  [View article]
    Great write up.

    Since the early 70s high rates have followed high inflation, on the back of energy prices / oil shocks. Energy and nearly all commodities are in a slump, affecting output of everything physical and transported. There is no inflation, and non on the horizon. Fed can look at what happened to japan after it raise rates -basically an excuse to appease the hawks, but all it did is create room for cuts again. If they raise in DEC it will be the one and only for a good while.
    Nov 13, 2015. 03:22 AM | 3 Likes Like |Link to Comment
  • Transocean cut to Sell with $10 price target at Clarkson  [View news story]
    Who the heck is Clarkson?

    Why should we listen to them? What is their track record? What is the methodology for setting the price target? What is the name of the analyst who published the report?
    Jul 10, 2015. 11:26 AM | 9 Likes Like |Link to Comment
  • Accelerate Diagnostics' Big Lie Exposed By SEC - $1.00 Target Within 18 Months  [View article]
    Once again, Starinvestor, there are many companies with no earnings, and pre FDA that have analyst coverage: GERN, IPXL, RLYP, PBYI, ICPT, .....
    Apr 29, 2015. 01:33 PM | Likes Like |Link to Comment
  • Accelerate Diagnostics' Big Lie Exposed By SEC - $1.00 Target Within 18 Months  [View article]
    GERN, IPXL, RLYP, PBYI, ICPT, ..... actually, there are many.
    Apr 6, 2015. 05:58 PM | Likes Like |Link to Comment
  • Orexigen - Honeymoon Continues With European Approval Of Anti-Obesity Drug  [View article]
    Can you indicate which one. Thank you.
    Mar 27, 2015. 02:25 PM | 1 Like Like |Link to Comment
  • Orexigen: Contrave Gathering Momentum  [View article]
    Standing Committee Adopts on 26 MAR 2015.

    QUOTE
    D037943/02 (Draft implementing measure/act) in dossier CMTD(2015)0288 DG Health and Food Safety

    Title: Draft COMMISSION IMPLEMENTING DECISION of XXX granting marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council for "Mysimba - naltrexone / bupropion", a medicinal product for human use

    Date: 16 Mar 2015

    Committee: Standing Committee on medicinal products for human use

    Basic legal act: Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Text with EEA relevance)

    Codecision: Yes

    Procedure: Examination Procedure (art. 5, 6 and 7)

    Status: Adoption 26 Mar 2015

    History: Draft Implementing Act submitted to Committee 20 Jan 2015
    UNQUOTE

    Link: http://bit.ly/1NjnfLa
    Mar 26, 2015. 12:24 PM | 1 Like Like |Link to Comment
  • Orexigen - Contrave Scripts Up, Equity Down, Approval In Europe Still Not Announced  [View article]
    Standing Committee Adopts:

    " 037943/02 (Draft implementing measure/act) in dossier CMTD(2015)0288 DG Health and Food Safety

    Title: Draft COMMISSION IMPLEMENTING DECISION of XXX granting marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council for "Mysimba - naltrexone / bupropion", a medicinal product for human use

    Date: 16 Mar 2015
    Committee: Standing Committee on medicinal products for human use


    Codecision: Yes

    Procedure: Examination Procedure (art. 5, 6 and 7)

    Status: Adoption 26 Mar 2015

    History: Draft Implementing Act submitted to Committee 20 Jan 2015 "

    Link: http://bit.ly/1NjnfLa
    Mar 26, 2015. 12:19 PM | 1 Like Like |Link to Comment
  • Orexigen - Contrave Scripts Up, Equity Down, Approval In Europe Still Not Announced  [View article]
    Please see this week's JAMA, released today. It has an opinion piece that is very positive towards Contrave. Article title: "Naltrexone Extended-Release Plus Bupropion Extended-Release for Treatment of Obesity".
    Mar 24, 2015. 05:19 PM | 1 Like Like |Link to Comment
  • Orexigen: Contrave Gathering Momentum  [View article]
    JAMA has a postive article about Contrave in this week's edition, published today. Search "Naltrexone Extended-Release Plus Bupropion Extended-Release for Treatment of Obesity" in JAMA.
    Mar 24, 2015. 05:17 PM | 1 Like Like |Link to Comment
  • Orexigen: Contrave Gathering Momentum  [View article]
    JAMA has a favorable article on Contrave in this week's issue, out today.
    Mar 24, 2015. 05:08 PM | 1 Like Like |Link to Comment
  • Orexigen - Contrave Scripts Up, Equity Down, Approval In Europe Still Not Announced  [View article]
    Thanks for looking at the script trends. All the other issues about law suits, data release, EU approval, have nothing to do with your article and are attempts to redirect the core message: doctors are prescribing and patients refilling, despite the black box warning.

    EU Commission has 30 days to publish its meeting minutes, and in its entire history it has overruled the CHMP, where the technical/scientific/m... skills are, once. In that occasion, new data was made available after CHMP met, and before the Commission voted, and that data was detrimental to the drug. The data released by OREX this time is not detrimental, and due to its early release, one could argue is inconclusive at best with respect to CV. Also, in that single occasion where the Commission overruled CHMP, it was at the request of CHMP itself.

    There are a lot of emotional shorts or ARNA investors who are throwing darts at everything, but the facts are what they are:

    - BofA states clearly that OREX met with the FDA regarding the disclosure though Jenkins says otherwise to Forbes and has refused interviews by the WSJ and Bloomberg

    - VTL was told this week by the FDA to not release early data (because there is nothing illegal about early release) and they obliged after seeing what happened to OREX. Their delay caused a sell-off. FDA is developing a policy on early disclosure as it goes along it appears. There is no CFR or USC on this subject.

    - OREX had always maintained, since mid 2014, that a second study would be needed.

    - Dig through the law suits and you find defendants include a person who was sued for bouncing checks at Wells Fargo, a firm founded by a former state AG who was driven out office and as former sheriff charged with illegal arrests, and later as a citizen filing numerous frivolous law suits. At then end, whether 2 or 50 such suits, they will have to be consolidated into a single suit, if at all. These are the bottom of the barrel firms.

    - Your analysis hits hard at those against this company because it shows scripts improving far better than rivals, long before OREX released interim data. It is a fundamental analysis that is detached from event-driven changes in value (regulatory, studies/trials).

    - Also note that every firm covering OREX has either upgraded, or increased PO in the last 90 days, and not been deterred by Forbes/Jenkins.

    Lastly, I think the FDA has put itself in a pickle by firing first ("the numbers are wrong but I am not a statistician"), using the media vs. standard FDA channels to communicate with the public, and refusing access requested by other media outlets to discuss the OREX matter. At the end, a symbolic slap on the wrist is likely for OREX, such as re-framing the already agreed-to second study to appear as a penalty.

    For the underweight shorts, let them eat cake. For the obese ones, Contrave.
    Mar 21, 2015. 02:12 PM | 6 Likes Like |Link to Comment
  • Surprise: Orexigen Investors Have Catalyst Looming Next Monday  [View article]
    Thank you for clarifying
    Mar 12, 2015. 03:05 PM | 2 Likes Like |Link to Comment
  • Surprise: Orexigen Investors Have Catalyst Looming Next Monday  [View article]
    Are referring to a different regulatory body? The EC CHMP meets on the 23rd.

    "23/03/2015 - 26/03/2015 : CHMP
    Committee for Medicinal Products for Human Use (CHMP): 23-26 March 2015
    The Committee for Medicinal Products for Human Use (CHMP) is the committee that is responsible for preparing the Agency's opinions on all questions concerning human medicines." source: http://bit.ly/18Efx0p

    Looks like meetings won't end until the 26th, and the committee publishes its minutes shortly thereafter, though they may do a press release on decisions taken.

    Just confused about the dates.
    Mar 12, 2015. 02:25 PM | Likes Like |Link to Comment
  • Orexigen's Contrave Blunder Due To Weak Intellectual Property Position  [View article]
    But even the FDA new drugs head who spoke to Herper of Forbers states he is not a statisticians when he makes the comments.

    Naturally, when you rehash the six Forbes articles published within 30 hours, and you take cues from FDA -who does not provide any analytic support and merely expresses frustrations- you will lend up with the same exact conclusion as Forbes.

    If anything, I suspect FDA may have been out of line. BofA/Merrill research notes state "OREX had dialogue with the FDA prior to March 3rd regarding issuing a patent (prior to filing the 8-K)." It could well be that BofA were among the signatories to NDAs allowing them to peak at the data. At any rate, I doubt a reputable company like BofA/Merrill would publish such a claim after the Forbers article without validating the fact. Who knows, perhaps various arms of the FDA were involved and they were not talking to each other. One thing is very clear: no one from FDA's statistical analysis group has yet to say anything about the data.
    Mar 11, 2015. 09:42 PM | Likes Like |Link to Comment
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