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Cymer Inc. Message Board

dcxavier 121 posts  |  Last Activity: 30 minutes ago Member since: Nov 22, 1999
  • How many insurance companies are going to pay for this for an insulin prescription? How many doctors are going to do this? Not many I'm guessing.

  • BOXED WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE

    Acute bronchospasm has been observed in patients with asthma and COPD using AFREZZA. AFREZZA is contraindicated in patients with chronic lung disease such as asthma or COPD. Before initiating AFREZZA, perform a detailed medical history, physical examination and spirometry (FEV1) to identify potential lung disease in all patients.

  • What AMPE says - "The present enrollment of over 355 patients provides an adequate power of 88%, which the company believes is more than sufficient for statistical evaluation."

    What AMPE means - "The data we have aren't close to meeting the 95% CI and aren't going to get any better, so we're going to wing it with what we have."

  • FRANKFURT/LONDON, June 23 (Reuters) - Bayer has struck an alliance with U.S. biotech firm Dimension Therapeutics to develop a gene therapy for the treatment of haemophilia A, marking renewed interest in an approach to tackle the cause of diseases at a cellular level.

    Gene therapy involves inserting corrective genes into malfunctioning cells to get them to work again without further use of drugs. Dimension has been looking into using viruses to carry the genes to the affected cells.

    Gene therapy has seen more than 20 years of experiments and a series of disappointments. However, Amsterdam-based UniQure is about to start selling its gene therapy drug Glybera in Europe as a treatment for the ultra-rare disease lipoprotein lipase deficiency (LPLD) with partner Chiesi.

    U.S. biotech firm Bluebird Bio last week reported positive results with an experimental gene therapy for another blood disorder, sending its shares soaring.

    Dimension Therapeutics will receive an upfront payment of $20 million and may get development and commercialisation milestone payments of up to $232 million. Bayer will also make royalty payments based on future product sales.

    Standard haemophilia A therapies are often administered intravenously multiple times a week and may be required for life.

    The German drugmaker's established haemophilia A therapy Kogenate had 1.2 billion euros ($1.6 billion) in sales last year. It has two more drug candidates against the type A of the hereditary bleeding disorder in the third and last phase of testing on humans that is required for regulatory approval.

  • Reply to

    $20 PPS

    by gladpick Jun 19, 2014 10:22 AM
    dcxavier dcxavier Jun 19, 2014 3:24 PM Flag

    HR is doing a decent job of increasing the market cap, but the dilution has knocked down the PPS. About 30% diluted in the past five years. After an extended lull, there will be a lot of market moving events in the next year.

    I took a position in BLUE on Tuesday. That company could be a ten-bagger or more if the technology works for sickle cell, or worthless if the early results for beta-thalassemia turn out to be a flash in the pan. Should know much more by the end of the year.

    Also cashing out some REIT's. This inflation talk can't be good for them even if the Fed tries to tamp down interest rates.

    Good luck all!

  • For those who own NCT in a taxable account. IRA is the only way to go.

  • Reply to

    Some final thoughts on ADCOM and NKTR

    by apcabforever Jun 14, 2014 9:38 AM
    dcxavier dcxavier Jun 16, 2014 11:09 PM Flag

    Except maybe for a milestone payment (which may be all PGNX is angling for), subcu Relistor for chronic pain isn't going to sell very much with an oral product on the market. SLXP/PGNX needs to get the oral product out. I wouldn't be surprised to see Movantik used off-label in palliative care patients if it gets approved.

    I mangled a few words when describing the instances of deaths in the Movantik studies. Properly stated, there were six CV deaths among study participants. All had taken Movantik at some point, there were no CV deaths among placebo/usual care only participants. Five of the six were high CV risk patients. There appears to be a trend, that Movantik adds to the risk of death in susceptible patients. Although the Adcom panel didn't find an overt signal, they didn't ring the all-clear bell either. Even if the CRL is reversed for subcu Relistor, it's hard to see how oral Relistor for chronic pain patients gets approved without a controlled, long term safety study. Do you think SLXP would see approval for oral Relistor for palliative care patients only? That might be possible.

  • Reply to

    Some final thoughts on ADCOM and NKTR

    by apcabforever Jun 14, 2014 9:38 AM
    dcxavier dcxavier Jun 16, 2014 8:51 PM Flag

    dr. vin and ca_fisherman,

    We've learned to never disagree with klaus. He's like the crazy uncle who lives in the upstairs back bedroom. He never lets facts get in the way of a good post. The best course of action is to nod your head and move on.

    That said, there is general consensus on the NKTR board that oral Relistor for chronic pain won't be approved without additional safety data. Existing data for Relistor essentially falls into three categories.

    1. SC Relistor field use for palliative care, aka body of evidence. By definition, this is uncontrolled short term use, and intermittent. There's no way you can evaluate Relistor as a contributing factor in cause of death among these patients.

    2. SC Relistor long term safety study, about one year of as needed use and uncontrolled.

    3. Oral Relistor short term efficacy study, four weeks daily followed by eight weeks as needed, controlled.

    Oral Relistor is intended for use over a long, long period. Perhaps daily for many years, maybe even life. It goes without saying that the PK of the oral version is much different from the subcu. I'm not sure you can project the safety of long term use of the oral version from the existing safety data. NCT01186770 was a one year controlled safety study that morphed into the twelve week efficacy study.

    All six subjects who died during the Movantik studies had taken the drug at some time, and five had high CV risk. I believe there is a very real risk that the FDA will require a black box warning against use in high risk CV patients pending further study. What do we know about the daily use of Relistor over a one year period?

  • Reply to

    Some final thoughts on ADCOM and NKTR

    by apcabforever Jun 14, 2014 9:38 AM
    dcxavier dcxavier Jun 14, 2014 12:06 PM Flag

    PGNX completed a successful Phase III efficacy trial on the oral formulation. SLXP is trying to slide by with uncontrolled safety data for subcu Relistor for non-terminal patients on the basis that it is both difficult and unethical to subject people to a year of placebo injections. Now SLXP is trying to use this uncontrolled data to suffice for approval for both the subcu AND oral formulations. Good luck with that. Maybe I'm the only one who believes this, but I would be shocked if the FDA approved oral Relistor without a controlled one year safety study, perhaps enriched with high risk CV patients.

  • Reply to

    Some final thoughts on ADCOM and NKTR

    by apcabforever Jun 14, 2014 9:38 AM
    dcxavier dcxavier Jun 14, 2014 11:48 AM Flag

    NKTR is the only company that really benefits from the decision over the next couple of years. That comes from the fat upcoming milestone payments that reduce the cash flow/dilution risk from the high cost R&D. I don't think that Movantik sales are going to ramp quickly. What money AZN collects will be funneled back into the post approval studies. SLXP/PGNX and CBST are at least two years away from an approved oral product. In fact, I think this is a net negative for SLXP/PGNX, especially if subcu Relistor doesn't get approved for chronic pain.

    OT: Check out what BLUE reported today. If they can even come close to replicating the results for sickle cell anemia, that will be a multi-billion dollar company.

  • Reply to

    AdComm recs (as best I can interpret them)

    by feeling_hijacked Jun 12, 2014 1:15 PM
    dcxavier dcxavier Jun 12, 2014 8:02 PM Flag

    cow,

    I didn't buy back, still don't own any. I absolutely agree with you, unless an unlikely CRL for more safety data in high risk patients materializes, Movantik will be the first oral drug to market with at least a two year head start. SLXP/PGNX is hosed. Even if subcu Relistor is approved, who is going to use it if an oral drug with comparable performance is available?

  • Reply to

    AdComm recs (as best I can interpret them)

    by feeling_hijacked Jun 12, 2014 1:15 PM
    dcxavier dcxavier Jun 12, 2014 7:49 PM Flag

    Finally free today and able to see what happened. With regards to your comments, hijacked, we did note that all six CV deaths reported from the naloxegol clinical trials in the FDA briefing material. All six involved patients who took naloxegol at some point. No participants who were in the placebo/usual care only group had a CV death. Five out of the six patients who died had a CV history when they entered the study. I haven't had time to review all the data, did AZN/NKTR document the percentage of study participants who entered at high CV risk?

    I don't think we can conclude the results are all sweetness and light. There are a range of possible outcomes here. There could be a CRL for AZN to collect more data on high risk patients prior to approval, but that doesn't seem likely. A post approval study is highly likely. One thing that could gum up the works is a black box warning against use in patients at CV risk until the risk is resolved in a post approval study. That wouldn't affect the milestone payments but would certainly put a dent in future sales.

  • Reply to

    Dr. Pasternack

    by dcxavier Jun 11, 2014 8:54 AM
    dcxavier dcxavier Jun 11, 2014 1:45 PM Flag

    Anyone watching now?

  • Reply to

    Dr. Pasternack

    by dcxavier Jun 11, 2014 8:54 AM
    dcxavier dcxavier Jun 11, 2014 9:33 AM Flag

    The big issue appears to be that the pharmacology of these antagonists is not well understood, so we don't know whether CV will be a problem either with the class or with the individual drugs.

    Unfortunately, I'll have to join the jury soon and won't be able to follow the discussion. I hope others are able to follow it online and continue to give updates.

  • Reply to

    Dr. Pasternack

    by dcxavier Jun 11, 2014 8:54 AM
    dcxavier dcxavier Jun 11, 2014 9:11 AM Flag

    One counterintuitive point... the higher the opioid tolerance in a person, the more sensitive they are to opioid antagonists.

    The big unknown... are these observations clinically relevant?

  • Reply to

    Dr. Pasternack

    by dcxavier Jun 11, 2014 8:54 AM
    dcxavier dcxavier Jun 11, 2014 9:08 AM Flag

    Noting that studies have shown some opioids have peripheral CV effects through the central nervous system.

  • dcxavier by dcxavier Jun 11, 2014 8:54 AM Flag

    Discussing how genetics affect how opioids work in humans, suggests that there may also be great variability in response to antagonists. That complicates the analysis.

  • dcxavier by dcxavier Jun 11, 2014 7:10 AM Flag

    Probably until the voting tomorrow. So sit back and watch the fun.

  • There could be a wild ride depending on the lines of questioning.

  • Avanir Pharmaceuticals, Inc. (AVNR) today announced that COMPASS, its Phase IIIb clinical trial comparing the efficacy and safety of the investigational product AVP-825 22mg to sumatriptan 100mg tablets for the treatment of acute migraines in adults, met the primary efficacy endpoint. AVP-825 is an investigational drug-device combination product consisting of low-dose sumatriptan powder delivered intranasally utilizing a novel Breath Powered™ delivery technology. In March 2014, the U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) of AVP-825 and the Prescription Drug User Fee Act (PDUFA) V goal date is November 26, 2014.

    The COMPASS study met the primary endpoint for the sum of pain intensity difference at 30 minutes post dose (SPID30), showing that migraine sufferers achieved greater pain relief within 30 minutes of treatment with 22 mg of the investigational product AVP-825 compared with 100 mg sumatriptan tablet.

    The overall safety profile of AVP-825, an investigational product, was consistent with that observed in previous trials, with less than 2% of subjects experiencing an adverse event leading to treatment discontinuation. There were no serious adverse events in the study. Nasal discomfort and abnormal product taste were more common with AVP-825 administration; these adverse events were deemed mild in nearly 90% of cases.

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