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Vertex Pharmaceuticals Incorporated Message Board

gladpick 35 posts  |  Last Activity: Jan 16, 2015 8:08 PM Member since: Jan 24, 2000
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  • Highlights of the Dec. 2 webcast follow.
    •Sarepta will work with the FDA to determine the feasibility of an accelerated approval for eteplirsen, while conducting the confirmatory studies necessary for standard approval. (See Confirmatory Study of Eteplirsen in DMD Patients, or enter NCT02255552 in the search box at ClinicalTrials.gov.)
    •Sarepta is also conducting a phase 2 study of eteplirsen in nonambulatory boys ages 7-21 (see Safety Study of Eteplirsen to Treat Advanced Stage DMD or enter NCT02286947 in the search box at ClinicalTrials.gov) and plans to open a phase 2 study of the drug in boys 4-6 years old.
    •The submission of an NDA for eteplirsen will be delayed by about six months from its original 2014 goal.
    •Sarepta understands the desire of the FDA to have as much additional information as possible and wants to honor the agency's requests, with the goal of creating as strong an application for eteplirsen as possible.
    •Sarepta will not be able to meet requests for expanded access (sometimes called "compassionate use") for eteplirsen because the company will need to focus all resources on obtaining approval for the drug; the amount of drug they are able to make is going toward the clinical trials that will lead to the submission for approval.
    •Sarepta is not only developing eteplirsen as planned, but it is also developing exon-skipping drugs targeting other parts (exons) of the dystrophin gene. Compounds targeting exons 45 and 53 are in clinical trials, and additional compounds are in preclinical development.
    •Sarepta hopes for an eventual approval of several DMD exon-skipping drugs as a class.

  • Reply to

    MDA'S SUMMARY OF DEC 2 PRESENTATION- PART 1

    by gladpick Dec 3, 2014 4:29 PM
    gladpick gladpick Dec 3, 2014 4:30 PM Flag

    PART 2
    •Sarepta hopes for an eventual approval of several DMD exon-skipping drugs as a class.
    •The company is encouraged by new data that support the methods it is using to measure dystrophin – the protein missing in DMD – in muscle biopsy samples; eteplirsen and other exon-skipping drugs for DMD are designed to increase functional dystrophin levels in muscle fibers.
    •Sarepta is pursuing approval of eteplirsen and other compounds in its pipeline with European, as well as U.S., regulators.

    "We continue to hear your urgency," said Garabedian in his closing remarks. "We assure you that it underpins all our activities here. At any moment that Ed [Kaye] or I see a softening of that urgency, we have many reasons to remind us that every day, week and month matters in getting this drug to patients."

  • gladpick gladpick Oct 29, 2014 1:08 PM Flag

    Their drug if it survives phase 2 , phase 3 and the approval process is an anti inflammation drug. There are already anti inflammation drugs in the market. It is my understanding that cystic fibrosis does cause inflammation of lungs and passage way. So an anti inflammation drug can only deal with one of the symptoms of the disease just like antibiotics such as Azithromycin that also deal with the infection symptom of the disease. Here is a quote from the CF Foundation about treating inflammation:

    "For example, ibuprofen, which is an anti-inflammatory, was found by CF Foundation-supported researchers to benefit people with cystic fibrosis. It can slow the rate at which lung function usually declines for some people with CF. However, patients need to be closely monitored by their CF physician if taking this drug for CF."

    However, VRTX CF drug franchise deals with the genetic disease itself.

  • Reply to

    FDA just issued srpt statemen

    by simp08801 Oct 30, 2014 6:18 PM
    gladpick gladpick Oct 30, 2014 7:34 PM Flag

    "The FDA is broken."

    You are absolutely right. The FDA consists of a bunch of bureaucrats who are only concerned about being 100% sure a drug is effective so their #$%$ is covered. They do not give a damn about suffering patients or a company that may go under as the result of their (FDA) decision.

  • gladpick by gladpick Nov 20, 2014 5:32 PM Flag

    The following are the recent timelines for Kennedy's posts:
    Nov 19 1:02 pm, 1 post
    6hours ago, 2 posts
    4 hours ago, 1 posts

    This is unusual for kennedy who usually posts many message every day.
    I guess he must be very depressed due to his short burning his #$%$.

  • Reply to

    the longer this clown goes without a real CSO

    by starfe11 Dec 3, 2014 4:03 PM
    gladpick gladpick Dec 3, 2014 4:34 PM Flag

    Are any of the competitors's drugs in phase 3? I thought they were in phase 1 or 2.

  • Reply to

    CVS DEAL

    by gladpick Dec 24, 2014 10:14 AM
    gladpick gladpick Dec 24, 2014 11:44 AM Flag

    "how do newer and better drugs get into the market?"
    keep in mind that these new HCV drugs cure 90 to 100% of the patients. So how new HCV drugs could be better than that? so it seems to me the exclusive agreement wil lock out ABBV for a long time. Keep in mind in the rare instances that the ABBV drug does not work the patient can get Sovaldi if a doctor recommend it due to lack of cure with the ABBV drug.

    As to drugs for other diseases, I suspect in any exclusive agreement if drawn properly, there will be clauses that nullify exclusivity IF and that is a big IF, a much much better drug is approved for a disease.

  • gladpick gladpick Nov 17, 2014 12:01 PM Flag

    What is the matter, your NKTR short is burning your #$%$?

  • Can't hear you!!!

  • Man, I am having fun!

  • Reply to

    Sofosbuvir patent and India

    by rojospan Jan 15, 2015 9:37 PM
    gladpick gladpick Jan 16, 2015 2:07 PM Flag

    Verity, that is a good one. Chuckles!

  • gladpick gladpick Nov 12, 2014 8:57 PM Flag

    Apparently you do not know much about how drugs are approved and marketed. It would do you a lot of good if you educate yourself about the topic before you post.

  • gladpick by gladpick Nov 19, 2014 10:33 AM Flag

    Let's assume the annual sale of cf franchise is $2B. Let's also assume that the annual cost of financing $3.3B is 3%. Subtracting this cost from the royalty of 6% leave a net of 3 %. 3% of the annual assumed sale of $2B= $60M net proceed per year. Dividing $3.3B by $60M=55 years.

    The above somehow does not make any sense because it means they have to wait 55 years before they make any profit. So let's assume the average annual sale is $4B. This would mean it would take them over 27 years before they make a profit if my assumption of 3% for cost of financing is correct. Somehow this still does not make any sense. So I think either my assumptions are wrong or my math is wrong. Anyone care to comment?

  • gladpick gladpick Nov 12, 2014 1:04 PM Flag

    " Out of the 7 trial sties, 3 are active no longer recruiting, 2 are recruiting, and 2 have not started recruiting. AM I reading too much into this that they can have this many without any disease progression to have two centers no longer recruiting."

    My guess is that each site is limited to a certain number of participants so as not to create a big imbalance between the various sites. This also prevents the final results of a trial to become invalid in case a site with a large portion of patients is found to have not followed the appropriate trial protocol.

  • Reply to

    Down 6% first hour of trading?

    by indexmagnet Dec 23, 2014 10:36 AM
    gladpick gladpick Dec 23, 2014 2:10 PM Flag

    I initially thought it was manipulation yesterday but the more i have thought about it the more i think it is because of the GILD issue. Actually, I think as of this minute VRTX has fared much better than most other biotechs. NBI, BTK ans IBB are down between 4 and 5 % as of this minute whereas VRTX is down only 2.74%.

  • gladpick gladpick Nov 12, 2014 8:58 PM Flag

    Now kennedy is talking to himself.

  • Reply to

    14th Annual Cr-ppy Stock Picking Contest

    by dcxavier Dec 19, 2014 9:02 PM
    gladpick gladpick Dec 31, 2014 5:23 PM Flag

    I will take VRTX.

    VRTX is the only company that has a drug to help those are afflicted with cystic fibrosis.

  • "The report cites the two current companies that can survive the competition onslaught, and perhaps ultimately get bought themselves.

    3D Systems Corp. (NYSE: DDD) has been an incredibly volatile stock, and now may be a good time for investors to revisit. Its 3D printers convert data input from computer-aided design generated software format or 3D scanning and sculpting devices to printed parts. 3D printing was a super-hot segment last year, and the top stocks were absolutely eviscerated in the early spring sell-off, and again in October. Hot and fast money loves to be long and short this top stock, so entry points are critical. The Jefferies team feels that the company’s product line is strong enough, but that it will be forced to lower prices to remain competitive and stay in the race."

  • Reply to

    CVS DEAL

    by gladpick Dec 24, 2014 10:14 AM
    gladpick gladpick Jan 5, 2015 1:30 PM Flag

    Good decision on GILD's part.

  • gladpick gladpick Dec 16, 2014 10:34 AM Flag

    BTK, NBI, IBB were each down only around 2.75%. However NKTR was down 5.2%.

VRTX
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