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Sirius XM Holdings Inc. Message Board

hellbent500 7 posts  |  Last Activity: Jul 14, 2016 10:40 PM Member since: Oct 14, 2009
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  • Reply to

    REGN and OPK

    by bui.p Jun 15, 2016 11:23 AM
    hellbent500 hellbent500 Jul 14, 2016 10:40 PM Flag

    Nope. OPK was as low #$%$38 in the beginning of 2013 and only closed above 11.00 for the high in December of 2013. Hamster math is hilarious!

  • Reply to

    It's rather comical

    by jakelawless1 May 11, 2016 9:00 PM
    hellbent500 hellbent500 Jun 6, 2016 9:35 PM Flag

    XI is a Cadillac, SI was a Volkswagen. This thing is a tricycle at best.

    It amazes me how retail investors just want to discredit someone in the field who has hands on.

    Credential questioning or simply calling "BS". I have over 3000 logged hours in robotic surgery and these guys still will not listen.

  • hellbent500 hellbent500 Jun 6, 2016 3:56 PM Flag

    You're assumptions are amazing. "Competitor at a davinci meeting"? Nothing wrong with that as its smart business, the problem is, I never said I brought up TRXC at a davinci meeting.

    I spent over 3000 hours on robotic surgery. Ask how many hours "the experts" here have.

  • Reply to

    mmarcusmd

    by jersey140 Jun 3, 2016 7:08 PM
    hellbent500 hellbent500 Jun 5, 2016 8:12 PM Flag

    1. Ease of set up. The multiple arm set up is really not applicable to davinci platforms as they are all attached to the single patient cart and moved in as a single unit. Yes, there are 4 arms but they come in together. On the XI all arms are placed at the same time via a lazer projected down and aligned with the trocar used for the camera. Camera is then inserted, target anatomy is identified and the arms adjust automatically. Dock and you're finished.

    2. Self cleaning camera is intriguing. If it's effective it would be a time saver. This would be a first as all laparoscopic lenses Need to be cleansed manually.

    3. Mobility. Is not unique to sport. Davinci platforms when stowed are very mobile and utilize a small footprint. As for the surgeons cart, yes, sport folds up and would provide for a somewhat smaller footprint.

    4. Replaceable tips will be cheaper then davinci instruments and provide a beat to ALFs reusable ones. This is a patient safety issue and a plus, any instrument used in robotics has a limited life. To make a claim that they don't need to be replaced is going to hurt someone down the road.

    Keep in mind that this is what the company wants you to hear but it looks much more promising then TRXC's Surgibot. I'm not compairing to ALF as Sport is based on SILS. SILS is the issue here as its not a procedure that's in favor with surgeons. SILS itself has not coughs on in the 10 years it's been around.

  • Reply to

    Davinci vs Surgibot & ALF.

    by hellbent_is_back May 30, 2016 12:15 AM
    hellbent500 hellbent500 Jun 5, 2016 5:50 PM Flag

    As I sad before it failed to get recognition in the US from surgeons when'd it was demoed. This has nothing to do with the FDA.

  • Reply to

    Davinci vs Surgibot & ALF.

    by hellbent_is_back May 30, 2016 12:15 AM
    hellbent500 hellbent500 Jun 1, 2016 8:53 PM Flag

    Typos happen but you might look at the beginning of this perticular thread. My position is a senior lead technician in our robotics program with davinci SI and XI platforms. I scrub every case I'm involved with and know the inner workings of both systems more then the surgeons do. I operate inside of the sterile field with the surgeons that perform the surgery as both assistant and technician. I am responsible for patient safety, instrument changes, and intraoperative diagnostics of equipment if necessary.

    As for the value of TRXC and buyouts, that's entirely different then why I am posting. As for the business side I'll leave that alone but I can tell you patient infringement is just one issue they currently have. ALF was introduced into the US market once before and it's reception by the surgical community was a great big "sigh".

  • OPKO Health Says FDA Accepts Resubmission Of NDA For Its RAYALDEE

    OPKO Health, Inc. (NYSE: OPK) disclosed that the FDA in the United States accepted its resubmission of the New Drug Application (NDA) for its RAYALDEE (calcifediol) on April 22. The company said that the drug candidate was for the treatment of secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.

    OPKO indicated it resubmitted the NDA after the receipt of a complete response letter (CRL) from the FDA on March 29, 2016, in which the regulator indicated the NDA could not be approved due to deficiencies observed during a facility inspection of OPKO's third party manufacturer.

    The company said the observations were not specific to RAYALDEE manufacturing, and the CRL did not point out any safety, efficacy or labeling issues in respect of RAYALDEE, nor did it request any additional studies to be conducted before the FDA approval. The drug firm said that a six month review period was assigned for the resubmitted NDA, and that the new Prescription Drug User Fee Act (PDUFA) date would be October 22.

    OPKO' Chairman and CEO Phillip Frost commented, "We have worked closely with our third party manufacturer to ensure the FDA's inspection observations are promptly and fully addressed, and we believe that our resubmission reflects OPKO's strong commitment to providing a new treatment for SHPT in CKD patients as soon as possible. If approved, RAYALDEE will be the first drug approved for this important indication."

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