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XOMA Corporation Message Board

mdwhittier 60 posts  |  Last Activity: 33 minutes ago Member since: Sep 17, 2012
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  • mdwhittier mdwhittier 33 minutes ago Flag

    I get all of that pasteur. I don't need your "this is clinical trial 101 stuff" reminder. Given that Etep. wasn't meant to be the cure-all, it simply has to show meaningful clinical benefit.

    Really, there are oncology drugs that merely prolong life by a matter of months, that have gained FDA approval. That Etep. slows progression of the disease is mostly agreed upon by the majority of DMD experts I'm confident that future trials will continue to show that Etep. slows progression of disease, and provides meaningful clinical benefit to these boys. Future trials may also include readouts on pulmonary function, as part of the trial endpoints, which would be very appropriate. I'm in for the long haul with SRPT. This downdraft worries me not one bit, and I can still sleep at night.

    Sentiment: Strong Buy

  • Reply to

    Simp

    by jim_himmel 8 hours ago
    mdwhittier mdwhittier 54 minutes ago Flag

    Many longs here share your pain, myself included. However, since I'm long in Roth/IRA accounts, and don't need the $$ for many years, I really don't care about these kind of events. I'm confident that next year will bring good news on several fronts, from the company and the stock valuation will reflect that. A year from now, this will be just a big hiccup in the rearview mirror.

    Sentiment: Strong Buy

  • mdwhittier mdwhittier 1 hour 0 minutes ago Flag

    This is not unheard of, and given that A.F. has been four-square positive on Etep., and believes that it will likely be approved, he was a logical choice for early journalist contact.

    Also, he's street savvy, and knows the reality of the trading landscape. He was able to prepare his piece ahead of the bell, but it didn't influence the trading overall. A.F. can pack some punch, but in this case the data was a tough pill to swallow for longs, and the shorts jumped at the chance to push the stock lower, and trigger sell stops, furthering their gain.

    C.G. is as good a CEO as you'll find in the biotech world. If you don't like the CEO or the stock then get out.

    Sentiment: Strong Buy

  • mdwhittier mdwhittier 1 hour 8 minutes ago Flag

    I'm with you, neuro21. Body mass index must be a part of the calculus in this equation.

    On a separate topic, you'd think that the level of pulmonary functioning (maintaining vs decline) would also become a marker in the overall benefit profile of Etep. Given that natural history progression eventually leads to the need for ventilation, it appears that Etep. may keep these boys off of ventilators, and this surely must be considered a significant clinical benefit. I wonder if future trials have this built into the design assessment. If not, it should be.

    Sentiment: Strong Buy

  • mdwhittier mdwhittier 6 hours ago Flag

    Hey greyzone, think about it; there's lots of ways for leaks to occur that are completely outside of C.G.'s control. Look at it this way, in 6-9 months, if you were a member of the AdCom, and the drug showed significant stability in pulmonary function, which increased life span by a measure of years, how would you vote? This is a fatal disease, right? Remember, these boys are growing and gaining weight with reduced muscle capacity. A decline in benefit, given at average age of 12 yrs. isn't shocking. At some point, this isn't just about the 6-mwt.

    Sentiment: Strong Buy

  • Reply to

    Ding-a-ling Carl

    by likeafox7210 10 hours ago
    mdwhittier mdwhittier 6 hours ago Flag

    Not sure how you interpreted "over promise" but I don't think he's guilty as charged. This is new territory at 144wks, and while the data showed more significant decline (6mwt) in the placebo delayed cohort, this is a lot less than historical disease progression would predict. Look at it this way, if you were a member of AdCom, and the drug showed significant stability in pulmonary function, which would increase life span by a measure of years, how would you vote?

    Sentiment: Strong Buy

  • mdwhittier mdwhittier 10 hours ago Flag

    Exactly! Would the FDA deny a drug that improves the pulmonary functioning of DMD boys sufficiently enough to prolong their lives? Let's not lose sight of the greater good here for Eteplirsen. FDA will approve in due time.

    Sentiment: Strong Buy

  • mdwhittier mdwhittier 10 hours ago Flag

    Yes, it's a big hit to the share price, but not surprising. Your point, yags, is what true investors are focused on. If a child with DMD loses the ability to walk, but maintains sufficient pulmonary functioning, then the drug has prolonged life, period. This alone would be sufficient reason for AA, and eventual FDA approval. I remain unwavering in my belief that this drug is significantly better than the alternative of no treatment. That's the crux of the matter.

    Sentiment: Strong Buy

  • When asked by the interviewer on CNBC, a bit over a month ago, about the high level of short interest and was C.G. concerned about that, he responded: (paraphrased) There's a greater likelihood of surprises to the upside than the downside.

    My thinking about the delay in the 144wk data is that there will be some variability in performance, which could give more ammunition for the shorts. While withholding information that is "material" would present problems for the company, I don't think this is the case. My hunch is that the data will be released in tandem with additional news about progress on their PMO platform, which will overshadow any potential negatives from the 144wk data.

    As an aside, those of you who also hold shares of ACAD (as I do) must have noticed a somewhat parallel trading pattern for these two stocks, over the past 6 months. Both companies have no materially important binary events, or news of import until Q-4 2014. The absence of important data just makes the stocks more vulnerable to short pressure. It's a tough waiting game, and weak hands get shaken out.

    Sentiment: Strong Buy

  • Reply to

    Scottrade Email Alert

    by tjones9234 Jul 2, 2014 6:50 PM
    mdwhittier mdwhittier Jul 7, 2014 2:59 AM Flag

    This is a tough one to predict. Schizophrenia has many different facets and dimensions. It may turn out that pima has greater efficacy at preventing psychotic episodes. But even as a co-therapy it has great potential to lessen the negative side-effects of drugs like risperidone, since the dosage of that drug can likely be reduced.

    The main difficulty, in terms of treatment, is getting those who are diagnosed to take their medication regularly. In the adult population, outside of clinical settings, there are often issues with substance abuse, which further complicates treatment. In the early stages of diagnosis, achieving compliance with medication can help to limit the severity of the disorder, as the patient gets older. But since the side-effects are often so miserable, patients often don't take their meds, or they begin to feel more normal and discontinue treatment.

    The difficulty with Pima in this indication is figuring out how it can be efficacious as a stand alone drug, and with which patients, versus it's use as a co-therapy with existing anti-psychotic medication.

    Once revenue begins to come in for PDP, it will help fund further clinical trials in schizophrenia. That's what I'm sensing here. GLTA

    Sentiment: Strong Buy

  • Reply to

    Scottrade Email Alert

    by tjones9234 Jul 2, 2014 6:50 PM
    mdwhittier mdwhittier Jul 6, 2014 9:12 PM Flag

    This was a co-therapy Ph.2 - not a stand alone therapy Ph.2. Mr. Wang's assertion, in his follow-on post, that there was an absence of dd on my part is false.

    Sentiment: Strong Buy

  • Reply to

    Motley article

    by naturallaws1 Jun 26, 2014 8:35 PM
    mdwhittier mdwhittier Jul 6, 2014 2:48 PM Flag

    Let's face reality here. MF article captions and their stories are designed to get nothing more than page views for MF. End of story. Plus, a stock that doesn't have any binary events in the near term makes a tempting short target. By middle of Q-2, 2015 the share price today will seen like a screaming buy.

    Sentiment: Strong Buy

  • Reply to

    Scottrade Email Alert

    by tjones9234 Jul 2, 2014 6:50 PM
    mdwhittier mdwhittier Jul 6, 2014 2:34 PM Flag

    But that's a no-brainer for ACAD, at this stage of the game. Approval for PDP and the stock goes to $50; with ADP, then $80-90. If schizophrenia indication gets good Ph.2 results, then suitors will be lined up. It's simply a waiting game at this point, but all signs point to Pima being extremely safe and efficacious. Remember, the other leading anti-psychotic drugs on the market have miserable side-effect profiles. As more data (particularly drug-drug interaction), comes in from the ADP trials, the perceived value of Pima just goes up. Unless one of the major pharm co's comes up with a better anti-psychotic compound, ACAD is leading the pack here.

    Sentiment: Strong Buy

  • mdwhittier mdwhittier Jul 1, 2014 3:59 PM Flag

    He's like an annoying mosquito, the male variety, all buzz but no bite.

    Sentiment: Strong Buy

  • mdwhittier mdwhittier Jun 27, 2014 11:22 AM Flag

    You nailed it, cigan'56. In the relative absence of news, and all the nervous nellies speculating about weakness in the 144wk data, market manipulation is more easily achieved. The HFT algos create the T/A signals that less sophisticated trading programs predictably respond to.

    Sentiment: Strong Buy

  • mdwhittier by mdwhittier Jun 25, 2014 2:43 PM Flag

    Unusual activity here. A trade of 1,800 options today at a price of $37.85. The seller must have confidence that the stock isn't going to collapse. Interesting hedge.

    Sentiment: Strong Buy

  • Reply to

    Seems like pending news

    by alleg180 Jun 24, 2014 3:04 PM
    mdwhittier mdwhittier Jun 25, 2014 12:41 AM Flag

    Imagination, run amok.

    Sentiment: Strong Buy

  • Reply to

    Today does depict long term outcome here

    by simp08801 Jun 24, 2014 3:49 PM
    mdwhittier mdwhittier Jun 24, 2014 5:06 PM Flag

    Really Simp? Your speculative musings are tiresome. The company, and the stock do not exist to serve you. SRPT is a speculative stock, just like VRTX, and if you look at that 5 year chart it's been a wild ride. Expect nothing less from SRPT. The only thing that would torpedo the stock at this juncture would be some heretofore unforeseen side effect after long-term use of Etep. That doesn't appear to be the case for now. Worries about some slippage in the 144 week 6-mwt is understandable; the drug is not a cure. Biotech is a land of volatility; get used to it or get out. Sorry, but it's time to IGNORE you.

    Sentiment: Strong Buy

  • Reply to

    reasonable deductions

    by simp08801 Jun 22, 2014 1:36 PM
    mdwhittier mdwhittier Jun 23, 2014 12:14 PM Flag

    simp08801: your hand-wringing is simply annoying. The 144 week data will need to be evaluated on a case-by-case basis, since every boy in the study responds differently to drug, based upon their age and overall level of muscle deterioration before the trial began. It's already evident that older boys are not helped to the same degree by Etep. as boys who began the trial at younger ages. As boys grow and become heavier, there is greater load demand on available muscle, which is in decline. Efficacy will likely be greatest with the youngest boys who received Etep. from the start of the trial (not placebo delayed), and how their decline (or lack of) compares with historical data of typical disease progression. It's the rate of decline for each boy, compared to natural history data that matters. The evidence will probably show (similar to recent data with mice) that treatment which begins at earlier ages results in the greatest efficacy. This will probably hold true with other exon deletion trials.

    SRPT is moving ahead with development of manufacturing facilities because they know the data, and the data is sufficiently valid to eventually pass muster with FDA. Eventual approval is no longer in question; it's just a matter of time, IMO. usagary1, in his response to you, said it most succinctly.

    If you continue to obsess over the 144 week data, can't sleep at night, and continue to leak your anxiety all over the board, don't own the stock. Simple enough.

    Sentiment: Strong Buy

  • From Bionerd's twitter feed: ncbi.nlm.nih.gov/pubmed/24942628
    "Exon skipping restores dystrophin expression, but fails to prevent disease progression in later stage dystrophic dko mice."

    Even though a mouse model, this study validates what has long been postulated by many on this board and others: the earlier that Etep. is given, prior to age 7, the greater benefit in terms of halting disease progression.

    What we can likely expect from the 144 week data is that the older boys in the cohort will likely show a decline in the 6-mwt from the prior data point. The shorts will likely use this data to further their agenda, at least in the short term. Regardless, Etep. will eventually be approved, but this approval won't come soon enough for children with DMD who could benefit from this PMO type of treatment.

    The regulatory delays that prevent AA for Etep. can be measured in children's lives, and untold heartache for the boys and families who live with DMD every day.

    Sentiment: Strong Buy

XOMA
4.11-0.15(-3.52%)Jul 10 3:59 PMEDT

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