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Clemens interview is on ESPN's MLB website
http://baseball.espn.go.com/mlb/index
I am watching it now.
Just curious (after the first remark) what if Clemens *thought* he was getting B-12 and lidocaine and McNamee give him something else?
I did not see it do you have a link? I'll admit to being a skeptic and will believe him testifying when I see it. Then will he answer like he did (dodged) taking the polygraph? Or will he decide to take the route of others who gave their versions of the truth.
I think an earlier poster had a good point. The lawsuit allows Roger to go to washington and say while i'ld love to answer the pending litigation prevents me from doing so.
To me the polygraph is more important. Anyone can go to Congress and lie (in front of, behind the scenes, a part of or anywhere within shouting distance :)) fooling a lie detector requires more skill :)
Updates: Protease Inhibitor Program, Pirfenidone Information, Other-pipeline (removed PEG-Actimmune/PEG-Infergen), Misc.
InterMune http://www.intermune.com/
i-hub InterMune board: http://investorshub.advfn.com/boards/board.asp?board_id=8637
Call Summaries
Q1 2007 #msg-19408521
Q2 2007 #msg-23131457
Q3 2007 #msg-24264853
(See prior ReadMe’s for general information and Actimmune information)
Competitive Landscape for IPF
1. Genzyme (collaboration with what was CAT) in Phase 1
2. Bosentan (Tracleer) from Actelion, Phase 2 failed in their endpoint proceeding with Phase III (BUILD-3) 390 patients, event-driven study (131 events needed defined as decreased FVC and DLCO, acute exacerbation, or death interim analysis with 62 events) randomized 2:1.
3. Imatinib (Gleevec), I believe it failed Phase 2 not sure of status going forward.
4. Etanercept (Enbrel), Phase 2 mixed results (no effect on endpoint; trend towards reduced disease progression)
5. Sildenafil (Phase 2) http://www.clinicaltrials.gov/ct/show/NCT00352482
6. Pipex (Tetrathiomolybdate) Phase I-II completed. Company filings say plans to initiate Phase 3. Phase i-II presented results #msg-19613632
7. FivePrime (Collaboration with J&J) http://tinyurl.com/yz444l
8. Fibrogen FG-3019 (for IPF) completed Phase 1 in patients (safe and well tolerated) http://www.fibrogen.com/uses/ipf.html
9. EmphyCorp N115 (ILD) http://emphycorp.com/ild.html
10. AlsoThalidomide being looked at, Others?
Pirfenidone
(See prior ReadMe’s for general and older information on Pirfenidone)
• IP Expansion and life-cycle management efforts underway since 2005
• Comments on Buyout of Royalty from Marnac #msg- 24817787
CAPACITY Trials, http://www.capacitytrials.com/
http://www.clinicaltrials.gov/ct/show/NCT00287729
http://www.clinicaltrials.gov/ct/show/NCT00287716 - Three Arm Study
• Primary endpoint is change in forced vital capacity (FVC) after 72 weeks of treatment
• Two concurrent, multi-national trials CAPACITY 1 and CAPACITY 2
• Randomized first patient April 27, 2006. Completed enrollment May, 2007. 779 total patients in 110 centers (North America and Europe). Results expected late 2008 or early 2009. Expansion of trials was targeting to enroll 720 (320 and 400).
• Not pursuing partnership at this time
• Differences between CAPACITY and Shionogi Phase 3 (Company presentations) Shionogi 250 patients, ours 779 (in 2 320 and 400 targeted in each of the studies not disclosed actual breakdown). Length Shionogi-52 ours 72 weeks. Dosing in Shionogi low dose 400mg TID high 600 TID, CAPACITY I-800mg TID, CAPACITY II 800mg and 400mg both TID, if account for avg. body weight of US/EU vs. Japan about 30mg/kg in each. Endpoint Shionogi change in Vital Capacity ours Change in Percent Predicted Forced Vital Capacity. Comparable measures of lung volume. Other difference is the patient population, Shionogi is Japanese ours is mainly NA and EU do not know of any metabolism difference in population or Pirfenidone between two groups.
• Power: > 95% to detect 50% reduction of FVC decline and > 85% to deduct 40% reduction in FVC.
InterMune 191 / PI Program
(See prior ReadMe’s for general and older information on 191)
• Phase 1B Trial Information
1. 9/4/07 Announced approval of amended CTA in Europe, expect to initiate in 9/07. Initial top-line data expected in Q1 2008. September 26th began dosing patients. Approximately 40 HCV patients.
2. Triple combination study expected to start in Q2 2008
3. January 7th 2008 announced completed first 2 dose cohorts of up to 300mg DAILY doses. Additional commentary and information on 1/7/08 Phase 1B update PR #msg-25802407
Other Pipeline/Interests
• Equity interest in Targanta Therapeutics, http://www.targanta.com/ as a result of selling Oritavancin in December 2005. (http://tinyurl.com/yznhod). Now public company trading under symbol TARG.
• Research work in both Hepatology and Pulmonology
o NiKem Research Srl collaboration in pulmonology (6/25/07 Nikem PR http://www.nikemresearch.com/news.htm)
o deCODE Biostructures collaboration (5/25/2007 deCODE Biostructures PR http://www.decodechembio.com/news_archives.php?year=2007 )
o Second generation PI’s (Roche Collaboration). Roche would have right of first refusal with terms comparable to 191 (up-front to be negotiated) if they decline InterMune can pursue other partnerships for candidate.
o Second target in Hepatology (undisclosed indication) Array collaboration. Royalty described by Array as high single digits. Array Responsible for creating clinical trial and all synthetic process. InterMune take into clinical development through commercialization. Partnership is described as met objectives and has been concluded.
Financials
• Cash/securities 264 million (end of Q3 2007)
• 170 million convertible. Coupon rate .25%. 2011 maturity. Conversion Price $21.63.
• 39 million shares outstanding
• 2007 Guidance
o Revenue (was 70– 90 million, removed with March INSPIRE study being stopped for futility)
o COGS (was 21-23%, removed with March INSPIRE study being stopped for futility)
o R&D 100-110 million. Including 5-10 million for est. FAS 123R.
o SG&A 25-35 million including 5-10 million for FAS 123R, excludes INSPIRE discontinuation expenses and possible contract wind-down costs (for Actimmune).
• Government settlement for past Actimmune promotion (http://tinyurl.com/y3wa8a) . The company will pay $36.9 million plus 5% interest over five years. The first annual installment of $5 million paid in 2006. Note some acceleration terms exist should InterMune receive 150 million in partnering/licensing (capped at $10 million/year).
• 10b5-1 plan entered into 9/07 http://tinyurl.com/2pok5z
Time-Line/Medical Presentations
• Q1 ’08 191 Phase 1B data expected (for at least 1st 3 dose cohorts)
• December’08/January ‘09 Top line results from CAPACITY
Some More thoughts on InterMune's news today #msg-25786271
[Forward looking statements may follow and may be reading too much into things]
On Dose Tested
1. We know the InterMune was going to test BID and TID and the statement says 300mg DAILY. We also know that Vertex doses at 800mg TID. So we are probably looking at efficacy with 1/8th the dose that Vertex used.
2. As the PI's developed and it became clearer that no way mono-therapy was going to work, InterMune calls became more focused on finding an efficacious dose that is well tolerated. There is a subtle distinction from what Vertex did. From my perspective it appeared that Vertex was looking to get maximal viral knock-down in the hopes of monotherapy then they got stuck at 800mg TID and exacerbation of the rash. InterMune’s mention of preparing for triple combination study reaffirms their stated goal to get efficacious well tolerated dose for combination use and not necessarily the maximum viral knock-down that can be achieved monotherapy.
3. The fact that InterMune stated the principal goals of the study were reached my guess is BID dose was found. While certainly they could have discovered that TID is necessary to maintain levels of the drug one would think they may have tried to push the dose more before moving on to looking into combination therapy.
4. So why keep pushing the dose in monotherapy? Here I have a disagreement with JPMorgan analyst Richard Smith who called the news “mixed”. Well he was surprised I can think of a few reasons to keep pushing the dose. First in patients who are not naïve to therapy and in other genotypes perhaps a high dose will be required so we need to make sure the drug can be safely titrated upward. Second, the PI may be used with other regimen’s (such as perhaps altering the PEG/ Ribavirin regimen and/or a Polymerase or other Proteases). Third (and perhaps not so significant) if people start comparing 191 head-to-head with telaprevir a more favorable comparison may be possible if the drug is studied as VX-950 was in early stage trials when the goal was maximum (monotherapy) efficacy.
On Price Movement
The stock was up significantly today but one needs to keep in mind the stock was in the mid 30’s less then a year ago. Lets recap what has happened since:
1) Actimmune INSPIRE study terminated. I had about a $10 value pegged to this portion of the company (others had less and the immediate drop was less)
2) People had fears that 191 had some sort of side-effect issue in 1A
3) The company did a financing for a little more then 4 million shares.
4) Other HCV compounds presented some interesting findings. People soured on Vertex and others (like us).
Now the positives
1) We not only went into 1B but found a safe and efficacious dose for combination use.
2) Vertex stumbled
3) Not only has 191 provided interesting findings in 1B but a Polymerase under Roche’s control (Pharmasset) is proving to be quite interesting as well. Roche is in better position then any other company to advance many other permutations of combination therapy (it doesn’t hurt that they have the financial resources to do so as well).
4) In addition to the company increasing duration and size of CAPACITY study (for Pirfenidone) the trial over enrolled (increased power) and the clock is advancing towards data and Shionogi hearing from the Japanese Health Minister (though we have no financial interest it would give some added validity to the results found).
5) The company made a heck of deal buying out the Pirfenidone royalty.
6) People forget that the we have a very active second generation Protease development program and we not only would get milestones but a to be negotiated up-front payment. In addition to the second array collaboration that produced a second hepatology target.
7) There are more hints on the other preclinical compounds that perhaps later this year they will be identified (beyond what has been).
Not yet (behind today) but you can get the archive at:
http://www.metameetings.com/webcasts/jpmorgan/healthcare08/ondemand.html
I think Amicus really got hit too hard after the presentation of their Fabry Data on the R&D day. I went over that broadcast several times and felt that the drop was way too extreme! It not only discounted the Fabry results but the platform to some degree. The Shire deal helps keep cash burn down and to me the big Prize is Gaucher and Pompe. Fabry already has 2 products AND ours was never going to work for a majority. That being said it seems ours may work better for late-onset and that may be a very largely under diagnossed group. And I am not convinced the FDA/EMEA won't agree to an amicable Phase 3 end point. To me the bigger concern I had was that they may not have found the optimal dose but to me even that was a manageable problem (especially since we don't have serious AE's to date).
FYI There is a call now. I joined late its still going on.
http://investor.pharmasset.com/eventdetail.cfm?eventid=48844
or from
http://investor.pharmasset.com/events.cfm
InterMune is less transparent then the market likes in addition to the Roche collaboration, I view Mr. Welch as conservative in nature especially with past management troubles with Actimmune. This PR as a strongly worded as I would expect given the data has not been released. Some of the critics should be silenced a bit with this. It is interesting Ying Yang of Jefferies (one analyst who while right on price I don't general think does a good job) gave a negative critic based on QD dosing when we don't even have TID dosing on the market yet! I think people were too optimistic on the PI's when Vertex was hot and now they are too negative. I think a happy middle ground should settle as candidates mature.
There is a lot of information in Mr. Welch's one quote! Perhaps I'll comment further in the near future. I think it speaks well to the company aggressively moving it forward.
http://biz.yahoo.com/prnews/080107/aqm149.html?.v=23
InterMune Announces Continuing Progress on ITMN-191 (R7227)
Monday January 7, 8:00 am ET
- Principal Goals of Phase 1b MAD Trial Already Achieved -
- Advancing to Triple Combination Trial -
BRISBANE, Calif., Jan. 7 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN - News) today provided an update on the progress of its Phase 1b multiple-ascending-dose (MAD) clinical trial evaluating ITMN-191 (R7227) as monotherapy in patients with chronic hepatitis C virus (HCV) infection. ITMN-191 is an HCV protease inhibitor in development by InterMune and its partner, Roche.
Dan Welch, President and Chief Executive Officer of InterMune, said, "We have now completed our first two dosage cohorts in the MAD study, with total daily doses of up to 300mg, and expect the third dosage cohort to be enrolled in January. We are very pleased to announce that after completing the first two low-dosage cohorts, we have already achieved the principal goals of the MAD study for viral kinetic performance, safety and tolerability and are now advancing the program to study ITMN-191 in combination with Pegasys® and ribavirin. In view of the very favorable safety profile observed to date, we will continue dose escalation in the MAD trial to a third and possibly fourth cohort in order to more fully evaluate the viral kinetic profile, safety and tolerability of higher doses of ITMN-191. In parallel with the conduct of the ongoing MAD study, we are preparing and will submit to the appropriate European authorities the clinical trial authorization application to gain approval to begin a 14-day triple combination study of ITMN-191 with Pegasys® and ribavirin in the second quarter."
The company also announced that it is on track to announce top-line viral kinetic and safety results from at least three treatment-naïve dose cohorts of the ongoing MAD clinical study later in the first quarter of this year. InterMune also expects to submit full data from all available cohorts of the current Phase 1b study for possible presentation at one or more scientific conferences in the second quarter of 2008.
Phase 1b (MAD) Trial Design
The ongoing Phase 1b placebo-controlled study is designed to assess the effect of multiple doses of ITMN-191 given as monotherapy on viral kinetics, viral resistance, pharmacokinetics, safety and tolerability. The principal goal of the MAD study is to help choose the dose of ITMN-191 that when administered in combination with Pegasys® and ribavirin, would likely offer the most competitive protease inhibitor-based triple combination regimen in terms of efficacy, safety and tolerability.
In the Phase 1b study, three or four cohorts of treatment-naive patients receive ITMN-191 twice per day (BID) or three times per day (TID) with food for a period of 14 days. In addition, a single cohort of treatment-experienced chronic hepatitis C patients infected with HCV genotype 1 will be studied once the treatment-naive cohorts are completed.
About InterMune
InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and hepatology. InterMune has a research and development portfolio addressing idiopathic pulmonary fibrosis (IPF) and hepatitis C virus (HCV) infections. The pulmonology portfolio includes the Phase 3 program, CAPACITY, which is evaluating pirfenidone for the treatment of patients with IPF and a research program focused on small molecules for pulmonary disease. The hepatology portfolio includes the HCV protease inhibitor compound ITMN-191 (referred to as R7227 at Roche) in Phase 1b, a second-generation HCV protease inhibitor research program, and a research program evaluating a new target in hepatology. For additional information about InterMune and its R&D pipeline, please visit http://www.intermune.com.
Forward-Looking Statements
This news release contains forward-looking statements within the meaning of section 21E of the Securities Exchange Act of 1934, as amended, that reflect InterMune's judgment and involve risks and uncertainties as of the date of this release, including without limitation the statements related to anticipated product development timelines. All forward-looking statements and other information included in this press release are based on information available to InterMune as of the date hereof, and InterMune assumes no obligation to update any such forward-looking statements or information. InterMune's actual results could differ materially from those described in InterMune's forward-looking statements.
Factors that could cause or contribute to such differences include, but are not limited to, those discussed in detail under the heading "Risk Factors" in InterMune's most recent annual report on Form 10-K filed with the SEC on March 30, 2007 (the "Form 10-K") and other periodic reports filed with the SEC, including the following: (i) risks related to the long, expensive and uncertain clinical development and regulatory process, including having no unexpected safety, toxicology, clinical or other issues or delays in anticipated timing of the regulatory approval process; (ii) risks related to failure to achieve the clinical trial results required to commercialize our product candidates; and (iii) risks related to timely patient enrollment and retention in clinical trials. The risks and other factors discussed above should be considered only in connection with the fully discussed risks and other factors discussed in detail in the Form 10-K and InterMune's other periodic reports filed with the SEC, all of which are available via InterMune's web site at http://www.intermune.com.
Its interesting how two people view things. The story on ESPN's website makes it seem like Clemens is interested in taking a lie detector test. The impression I got is the opposite. Since he can't obviously say no he sort of ducks the question and questions people believing them... Hmmmm
The interview didn't do too much to sway me into believing Roger. He seemed to contradict himself (indirectly) by saying he trusted people taking Vioxx like it was candy, so what would make one think he wouldn't trust people and take steroids if told it would help him? Oh yeah you get a third ear on your forehead if you take too much :).
Since I recently took a position in the company I was doing a search during happy hour on Zargis and in the mix of posts saw yours.
No new news at the company to my knowledge. The most recent Zargis news is a deal with 3M (next-generation Littmann stethoscope compatible with Zargis' heart sound analysis software):
3M and Zargis Announce Global Marketing Alliance
Thursday October 25, 11:40 am ET
http://biz.yahoo.com/prnews/071025/nyth058.html?.v=101
Speedus has been in decline for some time. It got so cheap that I took a little dabble in the mold of a Ben Graham play though I don't have a big position as I don't have much confidence in management getting it much above cash value.
Dew,
I hadn't realized Zargis had caught your eye (maybe I should become a paying iHub member :)). We are now a couple years post approval any idea why the product hasn't caught on?
I bought into the holding company (SPDE) recently a small position as a value play (they are selling at about .60 to 1 of cash not counting other assets). From performance and things I've read management is pretty suspect. I did a back of the hand calculation at break-up value and think I put a pretty nominal valuation on Zargis should it ever become a successful product but since it hasn't done anything the market is saying it is worth about -$5 million or so.
http://siliconinvestor.advfn.com/readmsg.aspx?msgid=24171760
Happy thanks for the info you provided in the PM. Sorry I am not a paying member here so replying publicly.
On the Shire Call today there was a question about the Amicus Data and Matthew Emmens, Shire's CEO said that there were no surprises in the data. They had seen it and they are very optimistic about chaperone technology. He thought that perhaps it was just a timing issue. He would not elaborate further.
Can you give any particulars about why you liked it? TIA
Thanks for the link thats not one I had in my book marks (the link worked). I actually buy many used books through http://www.abebooks.com/
I was more hoping anyone who had read it could give their opinion to see if it is worthwhile.
Couple of things from the Shire Morgan Stanley Call:
1-Considering Sale of Dynepo. (Sounded likely)
2-Amicus Data no surprises had seen it before. Think disappointment with timing (didn't elaborate) still very excited about technology.
The ADHD franchise I'll let others who follow this comment or suggest you listen to the call:
http://www.fulldisclosure.com/company.asp?ticker=SHPGY&coid=115161&client=cb
VRTX/SGP Wire news
Edited by John Shipman
Of DOW JONES NEWSWIRES
(call: 201 938 5171; e-mail:john.shipman@dowjones.com)
MARKET TALK can be found using N/DJMT
10:06 (Dow Jones) Wachovia cuts Vertex (VRTX) to underperform from market perform and slashes valuation view on concern about registration schedule of hepatitis C drug, telaprevir. Firm believes FDA may want data from ongoing phase II trial before sanctioning design of a phase III trial. The agency may OK a large, randomized three-arm phase III, though either move could push out launch to 2012 from 2010, firm says, allowing competition to enter the market. Wachovia cuts 2014 telaprevir US sales estimate to $827M from $1B and chops sum-of-parts valuation to $14-$17/share from $31-$35. VRTX down 3.2% to $22.40.
(TJG)
10:01 (Dow Jones) For months, analysts and drug-company insiders have fretted about crackdown on industry that could emerge after 2008 US presidential election. But Schering-Plough (SGP) CEO Fred Hassan sounds optimistic today, telling Morgan Stanley conference "our industry situation is relatively strong
compared to previous election cycles." He cites satisfaction with the new Medicare drug-benefit, which took effect two years ago. Also, the industry is doing a "more effective job at working both sides of the aisle." For evidence, take a look at industry contributions to the donkeys and elephants:
http://www.opensecrets.org/industries/indus.asp?Ind=H04. (PDL)
Thanks for the link I'll have to check it sometime.
Since I have not read it I can only go but what I heard which is the book I mentioned is supposed to be given evidence for God through science (the author was involved in the Human Genome mapping project if my recollection is accurate)
It could have something to do with people liking the company too :)!
I was surprised at how high they were able to price Kuvan. Steve Aselage has done an excellent job with Naglazyme uptake and I have little doubt that Kuvan will exceeded expectations too (but I think perhaps that market is thinking that too).
Their pipeline wasn't too strong but I imagine they are still likely to do a late stage deal and their early stage pipeline is filling out (especially their other PKU product (what was Phenylase forget the new name). They did some small low risk deals and have some undisclosed programs. BH4 for PAH or Sickle Cell could be very nice Niche indications (and still Orphan).
I don't put much into the prospects of BH4 in cardiovascular indications but that is a huge (upside) wildcard should any of the phase 2's be favorable.
I'd wish you luck but I am long BMRN :)
I guess so much for your January 35 BMRN puts. Not only does Cramer continue with them (BTW, I classify myself as Cramer indifferent) but there is WSJ piece with a fund liking them so even if the stock run-up was excessive it may not be before your options expire.
I haven't had too much success with the few times I've dabbled in options (UTHR only exception and that was a hedge to some degree). It seems you have two strikes against you outside of betting an event and having it going against you.
If anyone knows a good options strategy I'm all ears.
Poor grammar/wording. Was taking a guess I am not that knowledgeable in political history or old enough to remember :).
I was glad to see Jon's answer is not correct!
Since you said low difficulty I'll guess at something that seems too easy to be the correct answer.
Is it that no incumbent or VP is running?
If anyone has read the Collins book The Language of God, I would be curious as to your opinion on if it is worth reading. I've had it on a wish list more to not forget about wanting to read it one day don't know if I should make that day sooner rather then later.
I thought the article interesting in that believers and non-believers can interrupt things in the way that suits their interests.... I guess that is why faith is so important ;).
An interesting article in the NEJM on the Brain and God
http://content.nejm.org/cgi/content/full/358/1/6?query=TOC
Seeking God in the Brain — Efforts to Localize Higher Brain Functions
Solomon H. Snyder, M.D., D.Sc.
Neuroscientists have long eschewed global questions about brain function, and books reviewing the current state of neuroscience usually allocate only a small section to "higher functions." But with the advent of novel imaging techniques such as positron-emission tomographic scanning and functional magnetic resonance imaging, attitudes have begun to change. It is now feasible to visualize functions of discrete brain regions while subjects are engaged in diverse activities — doing arithmetic, composing songs, writing poetry, or watching pornographic movies. Information about which parts of the brain are activated during various mental activities has supplemented and, in general, confirmed previous insights derived from observations of alterations of thinking and feeling associated with brain lesions, epilepsy, and the use of diverse drugs.
Efforts to elucidate higher brain functions have intersected with a burgeoning literature on the neural underpinnings of not only language and art but also religion. At one extreme, some scientists, such as Francis Collins, in The Language of God, have even used what we know of molecular biology and brain function to argue for the existence of a personal God.1 Collins reviews anthropologic data emphasizing the universality of the search for God among a diverse group of primitive and advanced cultures over many thousands of years; he interprets this universality as implying that some basic structure in the brain "needs God." Similarly, noting that humans have an intuitive sense of right and wrong, Collins suggests that this characteristic, too, originates in an intrinsic structure of the brain. He goes so far as to conclude that the moral law was implanted in our brains by God, but many scientists have argued, from the same universality, that moral, altruistic behavior is programmed into the brain because it facilitates social behavior that leads to the preservation of the species.
Others have used similar data to argue that all of religion is an artifact of evolution. Neuroscientist David Linden, for instance, has recently suggested specific mechanisms whereby evolutionary alterations in the structure of the brain might account for the development of religion as well as love, memory, and dreams.2 As the brain evolved, he explains, the overgrown cerebral cortex came to overlie the more primitive, emotion-regulating limbic structures, which in turn surmount the most primitive brain-stem structures and the associated hypothalamus. Linden argues that the accidental linking of these portions of the brain accounts for many of the tribulations of humankind — anxiety and other emotional disturbances arise in substantial part from the ongoing war between the "rational" higher centers and the emotion-laden limbic system. Linden argues that if an "intelligent designer" had assembled the brain, it would surely have done an elegant, impeccable job, but the more we learn about the brain, the more clearly we see that it is an ad hoc concatenation of structures designed for unrelated functions — a sort of Rube Goldberg contraption. Though the brain somehow manages to function rather elegantly, breakdowns manifested in emotional and other disturbances are all too frequent.
Linden speculates about the neural mechanisms that may underlie religious impulses. He regards religious ideation as reflecting beliefs — such as the concept of a virgin birth or the notion of a God who knows every thought of every human being — that violate our everyday perception of reality. He likens such conceptualizations to the confabulations that persons with split brains arrive at in order to make sense of the incompatible data encountered by the two separated hemispheres.
In his recent book The Soul in the Brain, British neurologist Michael Trimble looks to his area of expertise, epilepsy, to explore a possible relationship between the human brain and religion: religiosity, he notes, is often brought to the fore by seizures.3 Trimble points out that some of the greatest religious figures in history had what were probably complex partial seizures, which are known to be associated with religious ideation. For instance, during Saint Paul's conversion on the road to Damascus, he is said not only to have suffered 3 days of blindness but also to have fallen to the ground frequently and experienced ecstatic visions. Muhammad described falling episodes accompanied by visual and auditory hallucinations. Joseph Smith, who founded Mormonism, reported lapses of consciousness and speech arrest, noting that "When I came to . . . I found myself lying on my back looking up at heaven." Joan of Arc reported, "I heard this voice [of an angel] . . . accompanied also by a great light."3
Trimble recalls that in The Varieties of Religious Experience, the 19th-century psychologist William James also highlighted the trances, visions, and auditory hallucinations associated with religion, emphasizing the ineffable, altered state of consciousness of most religious mystics. Such mystical states, encountered in most religions, remarks Trimble, are extraordinarily similar to the mental states elicited by psychedelic drugs such as LSD and mescaline. Almost 50 years ago, the psychiatrist Walter Pahnke came to this conclusion on the basis of experiments in which the psychedelic drug psilocybin was administered to students at the Harvard Divinity School. More recently, Roland Griffiths and colleagues have replicated these studies in a more rigorous fashion and found that subjects receiving psilocybin reported long-lasting changes in a religious sense of self.4 Drugs whose mechanism of action is understood can be powerful tools for elucidating the molecular basis of mental states — we know much more about the neurotransmitters that mediate emotions, for instance, from studying the actions of antidepressant drugs than from direct manipulations of the brain — and psychedelic drugs are known to act as agonists of one subtype of serotonin receptors.4 Since serotonin neurons arise from a discrete set of raphe nuclei in the brain, it may be possible to narrow the search for the biologic cause of at least one type of religiosity to these few cells.
But given the variability of what we mean by "religion" and "poetry," attempts to localize such purported functions within the brain are always fraught with hazards. With his focus on epileptic causes of both religious and creative impulses, Trimble enumerates several candidate regions, most of them in the temporal lobe — an area that receives a substantial input from serotonin neurons — which is consistent with what we know of sites of action of psychedelic drugs. In this issue of the Journal, Sanai and colleagues (pages 18–27) report on a study in which they mapped sites involved in diverse modes of language use in patients with gliomas who were undergoing debulking of their tumors. They found a far wider dispersal than might have been expected, with parietal and temporal as well as frontal regions providing important contributions. However, any extrapolation from a mapping of brain areas that mediate language use to likely cerebral contributions to religious or creative dispositions would be highly speculative.
So where do all these brain explorations lead us? In seeking a general relationship between religious states, poetry, and music, Trimble ascribes all three to the right, nondominant side of the brain. He assumes that integration of the activity of the right-sided emotional brain with that of the left-sided analytic brain gives rise to the greatest intellectual achievements in the arts. I suspect that major advances in science, too, are the product of more than pure reason — in the finest scientists I have encountered, I have always detected a notable creative, artistic flair.5 Artistic, intuitive approaches are evident even in the most abstract intellectual achievements, such as Einstein's theories. Needless to say, a simple dichotomy of right and left brains is a gross oversimplification. Nonetheless, as imaging technology and associated cognitive testing become ever more sophisticated, we may be able to discriminate ways in which religious and creative sensibilities relate to one another and to brain areas that mediate emotions that are deranged in psychiatric illness. Whether any of these advances will provide the answer to the cerebral basis of religion, if one exists, is anybody's guess.
Source Information
Dr. Snyder is a professor of neuroscience at the Johns Hopkins University School of Medicine, Baltimore.
References
Collins FS. The language of God: a scientist presents evidence for belief. New York: Free Press, 2007.
Linden DJ. The accidental mind: how brain evolution has given us love, memory, dreams, and God. Cambridge, MA: Belknap Press, 2007.
Trimble MR. The soul in the brain: the cerebral basis of language, art, and belief. Baltimore: Johns Hopkins University Press, 2007.
Griffiths RR, Richards WA, McCann U, Jesse R. Psilocybin can occasion mystical-type experiences having substantial and sustained personal meaning and spiritual significance. Psychopharmacology (Berl) 2006;187:268-283. [CrossRef][Medline]
Snyder SH. The audacity principle in science. Proc Am Philos Soc 2005;149:141-158. [ISI]
Biowatch,
Saw you went with EPIX in the charity biotech contest. Curious if you like a specific program (or two) think its cheap or something else.
I am not big on their obesity drug (the little I've heard about it), think their PH drug is too early to tell and would describe their Alzheimer's drug as interesting but early. The depression drug I don't have much idea on it (but don't put much value on it at this point considering past results though the rational going forward seems encouraging).
IMHO, The real upside (short-term) could come from the original EPIX namely Vasovist getting approved (and I guess sold off).
I doubt they'ld have Alzheimers 2B data by end '08 even if everything executes perfectly, so I am curious as to your take on it for 2008. TIA
For those interested the JP Morgan Website has been updated for the 26th Annual JPMorgan Healthcare Conference: Jan 7-10, 2008
If you want to see the list of presenting companies the link is: http://www.metameetings.com/webcasts/jpmorgan/healthcare08/agenda.html
You may first need to register at:
http://www.metameetings.com/webcasts/jpmorgan/healthcare08/
Also See Events list at:
https://events.jpmorgan.com/
Mike,
You do a good job at picking companies and research. I am starting to look at RBC I like to see numbers a bit further back is there anything I should be aware of that might throw them off (acquisition, new product launch, etc.)? Also do you know if there was there a one time even in Q2 '06? TIA
They may be in part a competitor of a company I own (PCYN) though I haven't done much research yet to know for sure.
A Nice article on the company though it is from March.
http://tampabay.bizjournals.com/tampabay/stories/2007/03/12/smallb1.html?t=printable
We are actually approaching two milestones:
1-the 1B 3rd cohort is probably well underway at this point and results are probably weeks away. Whether InterMune reports them immediately or does more cohorts then gives news I wouldn't venture a guess.
2-Shionogi should be hearing from Japanese regulators in the next couple months. I was disappointed they did not publish the full results yet (or at least I haven't seen anything beyond their investor day earlier this year). If approved it should remove doubts on anything in their data.
I was looking at the InterMune options and people seem to be heavy on the calls for April so I guess people are speculating on good results then. WIth the price decline perhaps they have been dumping their shares and buying the puts? Perhaps more interesting is how much little faith people have in Pirfenidone. There is a large amount of January '09 call options! If Pirfenidone is approved this will be a huge drug and I think the market will quickly realize that unfortunately people don't think much of its chances at this point.
I like that get the fans involved too :)! I am sure a class action suit could be made asking for ticket purchases to receive refunds.
I didn't follow it closely enough, perhaps one of the Yankee fans could talk more about it, but didn't they try to get out of Giambi's contract when it was discovered he used steroids? Though I am sure if his numbers wouldn't have declined they probably would not have tried :).
While we are making the lawyers rich I'ld like to see the Yankees (or other teams) sue players for fraud, violation of contract (they usually have a morals clause of some sort) or whatever else they can conjure up.
SMID -
So your the one topping my bid :)
I think a lot of people are lumping them into construction and being down on the whole construction segment. That is really just a portion (Slenderwall) their highway barriers have been strong and I think they've done good with their mix. For them 3 straight good quarters should be impressive enough and hopefully they've straightened out some of their past problems.
I'm really surprised at all the shares that have traded at sub $2 since the past quarterly report. I wonder if Rolland A. Adkins has gotten rid of his holdings (He filed late last year dropping under 5% and was much higher at one point).
Even though Q4 (and more so Q1) are traditionally low EPS numbers we're still looking at a (trailing) PE in the mid single digits people really have discounted the company!
The Moro Companies 12/28/2008
Moro Corp. (The Holding Company) http://www.morocorp.com/
- Current Ownership in 5 companies
Colmen Menard (Mr. Menard's Firm) http://www.colmenmenard.com/
- Firm does investment banking. Believe it is currently not very active. In addition to Mr. Menard, Mr. Corr plays an active role in Moro
The Companies
1) JM Ahle
. Acquired April 3, 2000
. Purchase Price $1,406,212
. Fabricator and distributor of reinforcing steel to contractors and subcontractors for use in the construction of highways, airports, bridges, treatment facilities, schools, public facilities, industrial and commercial buildings, and other structures.
. http://www.jmahle.com/
2) Rado Enterprises
. Acquired October 2, 2002
. Purchase Price $2,424,000
. Mechanical contractor engaged in various plumbing and HVAC
. http://www.radoenterprises.com/
3) Whaling City Iron
. Acquired April 12, 2004
. Purchase Price $655,159; Funded ($245K Cash on Hand, $75,159 liquidation of acquired assets, balance with Notes/Bank Debt)
. More details on the transaction (assets of Whaling) can be found in the 2004 Moro Annual Report
. Est. 11 Employees (D&B), Fabricates and distributes concrete reinforcing and structural steel
. http://www.wciron.com/
4) Appolo Heating
. Acquired March 1, 2006
. '05 Sales $12.6 Million, Revenue $1.1 Million
. Purchase Price: $3,307,275; Funded ($1.1 Million Cash on Hand, 950K in 10% Convertible Note, 50k sale of 5% interest in Appolo, balance with Notes/Bank Debt)
. More details on the transaction (assets of Appolo) can be found in the 2006 Moro Annual Report and some information also in the 2005 Moro Annual Report)
. 125 Employees, HVAC Contractor
. http://www.appoloheating.com/
5) J & J Sheet Metal Works
. Acquired November 1, 2007
. (Terms not yet disclosed)
. 45 Employees, Fabricator of Sheet Metal HVAC Products
. http://jjservicegroup.com/
I like to make the I-Box small, since the Old I-Box Info had some useful info its contents are being transferred to a regular message post. Its contents are below.
Contact Information Business Description
994 Old Eagle School Rd.
Suite 1000
Wayne, PA
19087
United States
http://www.morocorp.com
Phone: 484-367-0300
E-mail: info@morocorp.com
Moro Corporation is an industrial holding company specializing in the acquisition and management of industrial distribution, manufacturing and services businesses serving niche markets.
Moro is engaged in the fabrication of concrete reinforcing steel (rebar), sheet metal (duct work), structural steel and process piping; the distribution of construction steel, miscellaneous steel and construction accessories; and mechanical contracting services (HVAC, plumbing, piping).
Main SIC Code
3449 - Miscellaneous metalwork
State Of Incorporation
DE
Country Of Incorporation
USA
Year Of Incorporation
1992
Company Officers
David W. Menard, President
Lawrence J. Corr, Vice President
Number of Employees
250 as of Nov 17, 2006
Number of Company Locations
8 as of Nov 17, 2006
Edgar Filing Status
De-registered Edgar filer
CIK
0000940800
Fiscal Year End
12/31
Outstanding Shares
6,282,143 as of Feb 15, 2007
Estimated Market Cap
14,134,821.75 as of Mar 7, 2007
Authorized Shares
25,000,000 as of Feb 1, 2007
Float
800,000 as of Feb 1, 2007
Number of Share Holders of Record
195 as of Feb 1, 2007
Company Notes
Formerly=Food Court Entertainment Network, Inc. until 6-99
Class Notes
New Issue=10-95 2,800,000 shs in Units (1 sh Series A Com, 1 Class A Warr 10-11-2000 & 1 Class B Warr 10-11-2000) at $5 per unit by D.H. Blair Investment Banking Corp.
Transfer Agent
Stocktrans, Inc.,
1st Pennsylvania Bank Bldg.
7 E. Lancaster Ave.
2nd Floor
Ardmore, PA
19003
USA
Company Auditor
RSM McGladrey & Pullen
Blue Bell, PA
19422
USA
Legal Counsel
Lurio & Associates, PC
2005 Market St.
Suite 2340
Philadelphia, PA
19103
USA
Investor Relations Firm
Data Not Available
Scientific Meeting Calendar
NOTE: ANYONE MAY UPDATE THIS FILE
Edits: ASHG, ACMG, ESHG
MARCH
American College of Medical Genetics
15th Annual Clinical Genetics Meeting
Phoenix Convention Center & Hyatt Regency Phoenix, Phoenix, Arizona
March 12-16, 2008
http://www.acmgmeeting.net/
APRIL
European Association for the Study of the Liver
43rd Annual Meeting of the European Association for the Study of the Liver (EASL)
Milan, Italy
April 23-27
http://www.easl.ch/liver-meeting/
MAY
American Thoracic Society
ATS 2008
Toronto, Ontario, Canada
May 16-21
http://www.thoracic.org/sections/meetings-and-courses/international-conference/2008/index.html
Digestive Disease Week
DDW 2008
San Diego Convention Center, San Diego, CA
May 17-22
http://www.ddw.org/
European Society of Human Genetics - ESHG
The European Human Genetics Conference 2008
Barcelona, Spain
May 31 - June 3, 2008
http://www.eshg.org/
NOVEMBER
American Society of Human Genetics
Annual Meeting
Philadelphia, PA
November 11-15, 2008
http://genetics.faseb.org/genetics/ashg/menu-annmeet.shtml
Procedure For Updating Calendar
When adding or modifying entries, please follow these steps:
1. Copy the complete text from the old calendar. You can find a pointer to this list in the “iBox” at the top of the main message-board screen.
2. Make your additions or modifications, inserting any new items in chronological order.
3. Near the top of the message, give a very brief description of your changes (e.g. “Edits: Added entry for AASLD”).
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(cont.)
Sorry last sentence of message got cut off.
Of course because this is a thin stock normal caution should apply (I believe all my orders where limits).
For those who may be new to this company and looking to buy shares a few things to keep in mind:
1-My understanding is Mr. Menard isn't so eager to get off the Pink Sheets especially if OTC-QX becomes well accepted. Though I would much prefer being on NASDAQ in some form His reasons seem sound and one shouldn't expect a change soon (though it certainly is not outside the realm of possibility).
2-Given #1 and the extremely low float there can be huge spreads (30-50% have been quite common and about 10% seems typical).
3-I've often placed orders to not see my bid appear. Even have seen trades execute below my bid (Had better luck with some brokers over others but not all the time).
4-Shares can execute in small odd/quantities. I've had executions of 30-40 shares on several occasions.
5-With the maturity of the convertible that was due 9/07 some of the holders elected to receive shares 175k principal = 87,500 shares. My guess is some of these were sold on the open market as the stock has traded above $2, its anyones guess how many of those could be available for sale.
6-If you really want to build a position I had success paying at or near the ask. That was over a period of time though and the price did rise with any significant execution.
As I post the spread went from 2.1 - 2.5 to 2.2 - 3.0. Good luck to those looking to accumulate. I think it offers a compelling long-term value proposition!
Of course be c
Looking forward to the next quarterly call from mnta
Hopefully we get some sort of update before then. They're scheduled to present at BIO-CEO 2/11-2/13. Didn't see them on the JP Morgan list but I only go by the JP Morgan website (earnings.com doesn't always list all presenters) so maybe they'll still present there.
In an older call (Q4 2006) they also said they could petition the FDA to eliminate the 180 day waiting period based on futility of their (Teva/amphastar) application. But I am guessing this would take the better part of the 180 days to do. It sounded like IF they (Momementa) were approved that some sort of deal would be negotiated.
I was going back over an older call and Momementa said that Teva's application in Canada was approved but each province needed to put it on formulary which never happened and the application was delisted (rejected). They (Momementa) believed it was because of requirement to for trials. Has anyone ever heard anything about this from another source (like Teva)?
A cynic (I put myself in that camp) would say he is doing this because he has a big ego and to put doubt in peoples minds (which he appears to be doing).
I posted somethings he could do (granted he would be going the extra mile but if he wants to remove doubt it would help for me) #msg-25332149 he is doing #1 and more so then going in front of congress I'ld like to see #2 on my list with an emphasis on the public (and unrehearsed). I saw there is a new reality show with a polygraph coming, why not go on that? :)