...
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Question on VMIR -
For those of us who may not know how the Rebalancing is done can you point out a post or two to look at? I looked at the board a while back but didn't see it (sorry if i missed it).
ALso curious if you account for transaction costs?
I am more a long-term holder in stocks as I don't claim to be smart enough to pick tops or bottoms. The long vs. short term tax rate is something to consider too.
I read an article recently that referred to local bridges needing repair. In it they had a map (believe this is the same one). If one looks at the regions serviced by Moro (JM Ahle) there is a good chunk of business to be had in the coming years. SO even though construction in general may not be where investors are looking I think we'll hold our own. Then factor in that the HVAC has been doing excellent, we have one recent deal to add to EPS and the company has strong EPS and the ability to easily finance another deal or two (if opportunity arises and Mr. Menard has been able to do some great deals based on past history). So things are looking pretty good both now and in the future in my book!
Map on Bridges needing repair: http://www.msnbc.msn.com/id/20095291
Related Article: http://www.msnbc.msn.com/id/20095291
[Please see updating procedure at the end of this post. Events listed here are regular quarterly conference calls unless indicated otherwise. All times are U.S. ET. unless indicated otherwise.]
NOTE: ANYONE MAY UPDATE THIS FILE
Edits: Removed Old entries, Added JP Morgan and BIO CEO
CONFERENCES
BIO CEO
February 11-13, 2008
New York City
http://ceo.bio.org/opencms/ceo/2008/program/PresentingCompaniesList.jsp
JPMorgan Healthcare Conference
San Francisco, CA
January 7-10, 2008
http://www.fulldisclosure.com/conferencedetail.asp?client=cb&event=1608025
http://www.mapdigital.com/jpmorgan/healthcare08/index.php (not working as of 12/24/07)
---
Procedure For Updating Calendar
When adding or modifying entries, please follow these steps:
1. Copy the complete text from the old list. 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 alphabetical order.
3. Post the updated text in a new message in reply to the message with the old list.
Now I see why you were posting negatively about EPIX :).
I think some of your statements on 3140 were misleading (I clarified one or two of them #msg-25430495). Yes it is too early to judge and it certainly need not be a miracle drug to be a blockbuster!
If you have some insights on Transition's/Elan's drug I'd appreciate reading it. For what its worth I hope both treatments work. TIA
Bienaime's sale is small and rather insignificant. However what it tells us is that there is no near-term takeover of the campany as he would not have done so had he thought this is in the works.
FYI, the sale was made pursuant to a 10b5-1 trading plan.
FOLD:
what's going on with FOLD today
The short Answer is I don't know!
I think there may have been some disappointment about what the Phase 3 Fabry end point may be. One analyst in particularly was concerned about a clinically relevant non-pain end-point and if the Urine GL3 surrogate end point correlates with clinical relevance. Another analyst was concerned about the kidney biopsy GL3 measures (particularly in women). Company said leaning away from that as a measure as doesn’t seem broadly applicable.
I am at a loss for the big drop though some other (minor) things I could think of on first listen/look:
. May think don’t have the dose down yet (looking at higher dosing in extension studied particularly for the moderate responders).
. Gaucher data not presented yet (will be January 7th in SF)
. Parkinson’s drug is actually the Gaucher drug. Though 2nd generation in the works.
I wasn’t there so don’t know if more was elaborated on, though the stock started dropping in after hours during the presentation.
Do you think the congressional noise about making hGH a scheduled substance had anything to do with DNA’s decision?
Good point I hadn't thought about that possibility. I tend to think not though because Genentech had been taking a considerable amount of time in getting a partner x-US so I had been thinking something is amiss with the situation. But I tended to think Genentech was in no hurry for next generation Growth Hormone but was still very interested longer term in Altus candidate. They (DNA) did ink a deal with Tercica since perhaps they are developing something more akin to what DNA is looking for and they just wanted to stall ALTU? OK now I am starting to sound like some of those conspiracy posters.
The Amicus results and anecdotal reports of investigators are very promising I think I will go back to paying more attention there and not think so much about Altus :).
ALTU:
Berkle is probably my least favorite CEO (and I own Spectrum). If the deal wasn't working out he should have done something much sooner, now he has it set back 12 months or so and his attempt at spinning the news isn't going anywhere. So lets see 2 deals both terminated (Company required rights). 2 drugs in development two problems with mfg/drug supply. Top executives leaving, Stock ownership minimal, insider selling too much. Michael Astrue help!
http://biz.yahoo.com/bw/071219/20071219006133.html?.v=1
Altus Pharmaceuticals Reacquires ALTU-238 Global Development and Commercialzation Rights
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Altus Pharmaceuticals Inc. (NASDAQ: ALTU - News) announced today that it has reacquired ALTU-238 development and commercialization rights for North America from Genentech, Inc. Also, the Company announced that the exclusive option granted to Genentech for ALTU-238 development and commercialization outside North America has expired. ALTU-238 is a subcutaneously administered, once-per-week formulation of human growth hormone, which employs Altus’ proprietary protein crystallization and formulation technology, for patients with growth hormone deficiencies.
“We continue to believe ALTU-238 can provide significant patient benefit with better dosing as a potential once-per-week treatment for growth hormone disorders,” stated Sheldon Berkle, President and CEO of Altus Pharmaceuticals. “We intend to move this program forward. Our goal is to resume clinical trials by mid-2008 and we expect to provide additional details regarding the clinical development plan to investors during the first quarter. As a unified global program, we also believe significant strategic partnering opportunities exist for ALTU-238.”
Under the revised agreement, Altus regains control of its ALTU-238 assets and Genentech has agreed to provide, for a limited term, supplies of human growth hormone for future clinical development. In addition, Genentech will provide Altus certain funding to support transition of the program. Upon commercialization, Genentech will be entitled to a nominal royalty on sales of ALTU-238.
About ALTU-238
ALTU-238 is a long-acting subcutaneous formulation of recombinant human growth hormone, in a ready-to-use liquid suspension formulation, that employs Altus' proprietary protein crystallization and formulation technology. Altus' technology preserves the structure of the human growth hormone molecule without the need for polymers or encapsulation and enables administration through a fine gauge needle. Recombinant human growth hormone is approved for treating multiple growth disorders in children and adolescents and for growth hormone replacement in adults. Global sales for all recombinant human growth hormone were approximately $2.5 billion in 2006.
About Growth Hormone Deficiency and Growth Failure
Growth hormone disorders occur when the production of growth hormone, secreted via the hypothalamic–pituitary axis is disrupted. Growth hormone plays a critical role in stimulating bone growth and development and it is involved in the production of muscle and in the breakdown of fats. In children, when there is a deficiency or absence of growth hormone, growth failure occurs. Recombinant human growth hormone (rhGH) products are currently approved to treat multiple growth disorders, including pediatric hormone deficiency, Turner Syndrome, chronic renal insufficiency, idiopathic short stature, Prader-Willi Syndrome, short children born small for gestational age, genetic SHOX abnormalities, as well as adult disorders of growth hormone deficiency, short bowel syndrome and muscle wasting in patients with HIV.
About Altus Pharmaceuticals Inc.
Altus Pharmaceuticals, headquartered in Cambridge, MA, is a biopharmaceutical company focused on the development and commercialization of oral and injectable protein therapeutics for patients with gastrointestinal and metabolic disorders. The Company's website is http://www.altus.com.
Safe Harbor Statement
Certain statements in this news release concerning Altus’ business are considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, those relating to patient benefit related to ALTU-238 dosing, the future partnering opportunities and future rights to access supplies from Genentech. Any or all of the forward-looking statements in this press release may turn out to be wrong. They can be affected by inaccurate assumptions Altus might make or by known or unknown risks and uncertainties, including, but not limited to uncertainties as to the future cost, timing, enrollment and success of planned clinical trials; the continuing risks associated with the development and manufacture of products to supply the clinical trials, the unproven safety and efficacy of products under development and the outcome of regulatory review. Consequently, no forward-looking statement can be guaranteed, and actual results may vary materially. Additional information concerning factors that could cause actual results to materially differ from those in the forward-looking statements is contained in Altus’ reports to the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2007. However, Altus undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise.
Contact:
Altus Pharmaceuticals Inc.
John A. Jordan, 617-299-2852
Senior Director, Corporate Communications
For those interested the Analyst Day will start in about 15 minutes. Webcast at http://ir.amicustherapeutics.com/events.cfm
The top line results aren't a complete surprise as Shire had probably seen most of the data before the deal was made. Its interesting the number of Females in the study. I recall TKT saying the number of women with Fabry may be very high at one point it was believed only men could get the disease. From the top line data knowing that some patients have been on 2 years with good results is quite encouraging. I am curious as to what they determine to be the optimal dosing I believe Mr. Crowley had hinted that an every other day regiment may prove optimal. Genisi I'ld be curious on your take, a believer or not yet :)
http://biz.yahoo.com/prnews/071219/nyw094.html?.v=101
Amicus Therapeutics Announces Positive Results From Phase 2 Clinical Trials of Amigal(TM) for Fabry Disease
CRANBURY, N.J., Dec. 19 /PRNewswire-FirstCall/ -- Amicus Therapeutics Inc. (Nasdaq: FOLD - News), a biopharmaceutical company developing small-molecule, orally administered pharmacological chaperones for the treatment of human genetic diseases, announced today positive results from its recently completed Phase 2 clinical trials of Amigal(TM) (migalastat hydrochloride) for Fabry disease. As of November 2007, Amigal is being developed in partnership with Shire Human Genetic Therapies (HGT), a business unit of Shire plc, which is focused on genetic diseases. The results will be discussed as a part of an "R&D Day" meeting being hosted by the company today from 4:30 to 7:00 PM at the Four Seasons Hotel in New York City. A live audio web cast of the presentation will be available to all interested parties through the Company's website at www.amicustherapeutics.com. Interested parties should connect at least 15 minutes prior to the presentation to ensure adequate time for any software download that may be required to join the webcast. An archive of the webcast will be available at the same address until approximately January 2, 2008.
"The completion of these trials is a major milestone for Amicus and these clinical results represent an important proof of concept for the pharmacological chaperone platform technology," said John F. Crowley, President and CEO of Amicus Therapeutics. "We look forward to advancing our program in Fabry as well as Gaucher, Pompe, and other important therapeutic targets utilizing this new approach to the treatment of a wide range of human genetic diseases."
Summary of Study Results:
The primary objective of the Phase 2 trials was to evaluate the safety and tolerability of treatment with Amigal. The secondary objective was to evaluate certain pharmacodynamic measures of treatment, including effects on a-GAL (the target enzyme deficient in Fabry patients) and levels of GL-3 (the substrate that builds up in the cells of patients) in cells and tissues affected by the disease. An additional objective was the preliminary assessment of cardiac and renal function.
The four open-label, multi-national Phase 2 trials of Amigal enrolled 18 men and 9 women with Fabry disease between the ages of 17 and 65. The four studies examined various dose levels and frequencies of Amigal administration and had 12 or 24 week primary treatment arms with an optional treatment extension.
Twenty-six patients completed the primary treatment arms and all entered the optional treatment extension. The 26 patients had 21 different missense genetic mutations that cause Fabry disease. The mutations represented the full spectrum of Fabry patients, including those with both early-onset and late- onset forms of the disease. Twenty-three patients are currently being treated with Amigal under the treatment extension, including 8 who have been treated for more than a year and 4 who have been treated for almost 2 years.
"The positive results of these first trials of a pharmacological chaperone in Fabry disease are impressive," said Raphael Schiffmann, M.D., Lead Investigator at the Metabolic Neurology Branch of the National Institute of Neurological Disorders and Stroke (NINDS), a part of the National Institutes of Health, and a principal investigator in one of the Amigal clinical trials. "I believe this technology has the potential to be an important new treatment option for many Fabry disease patients."
The key findings in the Phase 2 studies were:
* Amigal was generally safe and well-tolerated at all doses evaluated. No
drug-related serious adverse events were reported during the primary
treatment arm, and none have been reported during the treatment
extension.
* Twenty-four out of 26 patients demonstrated an increase in a-GAL as
measured in white blood cells, kidney, and skin.
* a-GAL increases were seen in patients with both low levels of residual
enzyme activity (<3%) at baseline as well as patients presenting with
higher baseline levels (greater than or equal to 3%).
* Kidney GL-3 levels as measured in urine or biopsies were decreased in
patients who demonstrated greater increases in levels of a-GAL.
* Renal and cardiac function results were encouraging, including those
seen in patients treated for nearly two years.
* Patient responses were consistent with the results of in vitro testing
of Fabry mutations, thus improving the ability to select likely
responders for future studies.
"These data demonstrate that Amigal has a meaningful effect on a range of genetic mutations in Fabry disease and thus has the potential to treat a significant portion of the Fabry patient population," said William Wilcox, M.D., Ph.D., Director of the Metabolic Disorders Clinic at Cedars-Sinai Medical Center and a principal investigator in one of the Amigal clinical trials.
Amicus expects that the results will be presented again at the American College of Medical Genetics (ACMG) Annual Meeting on March 12-16, 2008, in Phoenix, Arizona.
Based on the results of these Phase 2 trials, Amicus and Shire plan to meet with US and European regulatory authorities to discuss the design of a Phase 3 clinical trial for Amigal.
About Fabry Disease
Fabry disease is a lysosomal storage disorder caused by inherited genetic mutations in the GLA gene, which result in deficient activity of the enzyme alpha-galactosidase A (a-GAL). Deficient a-GAL activity leads to lysosomal accumulation of globotriaosylceramide (GL-3), which is believed to cause the various symptoms of Fabry disease, including pain, kidney failure and increased risk of heart attack and stroke. Amigal is designed to selectively bind to and stabilize a-GAL, which facilitates proper trafficking of the enzyme to the lysosomes, where it is needed to break down GL-3. In a previous Phase 1 study, Amigal was shown to be safe and well tolerated and to increase GLA levels in white blood cells in healthy human volunteers. Additionally, pre-clinical studies showed that treatment of Fabry transgenic mice with Amigal can increase GLA activity and significantly reduce GL-3 accumulation in heart, kidney, skin and plasma.
Fabry disease is estimated to affect approximately 5,000 to 10,000 people in the developed world, but recent evidence suggests that the disease may be significantly under diagnosed. The U.S. Food and Drug Administration's Office of Orphan Products Development has granted orphan designation for Amigal in the United States, and the European Commission has designated Amigal as an orphan medicinal product in the European Union.
About Amicus Therapeutics
Amicus Therapeutics is a biopharmaceutical company developing novel, oral therapeutics known as pharmacological chaperones for the treatment of a range of human genetic diseases. Pharmacological chaperone technology involves the use of small molecules that selectively bind to and stabilize proteins in cells, leading to improved protein folding and trafficking, and increased activity. Amicus is initially targeting lysosomal storage disorders, which are severe, chronic genetic diseases with unmet medical needs. Amicus has completed Phase 2 clinical trials of Amigal for the treatment of Fabry disease and is conducting Phase 2 clinical trials of Plicera(TM) for the treatment of Gaucher disease. The Company has completed Phase 1 clinical trials of AT2220 for the treatment of Pompe disease.
Forward-Looking Statements
Amicus cautions you that statements included in this press release that are not a description of historical facts are "forward-looking statements" within the meaning of Section 21E of the Private Securities Litigation Reform Act of 1995. Words such as, but not limited to, "look forward to," "believe," "expect," "anticipate," "estimate," "intend," "plan," "targets," "likely," "will," "would," "should," and "could," and similar expressions or words identify forward-looking statements. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. The inclusion of forward-looking statements should not be regarded as a representation by Amicus that any of its plans will be achieved. Any or all of the forward-looking statements in this press release may turn out to be wrong. They can be affected by inaccurate assumptions Amicus might make or by known or unknown risks and uncertainties. For example, with respect to statements regarding the potential progress and results of clinical trials, actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in the business of Amicus, including, without limitation: the effect of the completion of the Phase 2 clinical trial for Amigal for the treatment of Fabry disease, the plans for the Phase 3 clinical trial for Amigal, the Phase II clinical trials for Plicera(TM) for the treatment of Gaucher disease, and the effect of the completion of the Phase I clinical trials for AT2220 for the treatment of Pompe disease may not proceed in the timeframes or in the manner Amicus expects or at all. Further, the results of earlier clinical trials may not be predictive of future results; Amicus and its licensors may not be able to obtain, maintain and successfully enforce adequate patent and other intellectual property protection of its product candidates; and other risks detailed in the public filings of Amicus with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward- looking statements, which speak only as of the date hereof. All forward- looking statements are qualified in their entirety by this cautionary statement and Amicus undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
Even their planned ph IIB seems way too small to move the trial into phIII if it is successful. I read in one of the analyst reports taht they planned to treat around 250 pts for 12 weeks in their ph IIB.
If they don't change it too much after what was seen in the 2a (and I imagine there will at least be a monotherapy arm). The company has indicated it will be about 100 patients in each arm (low and high dose) and a placebo arm. For a 2 point difference the power is 80% if the difference is 3 points they indicated it would be about 90%. The treatment period is 6 months too.
I plan to publicly answer all of those questions at the appropriate time in the appropriate way. I only ask that in the meantime people not rush to judgment.
Does anyone else find this statement interesting? When someone comes out and says something like this the first thing that crosses my mind is "Why can't you do it now?" and I don't think they are waiting for positive reasons.
Scientific Meeting Calendar
NOTE: ANYONE MAY UPDATE THIS FILE
Edits: EASL, ATS, DDW
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/
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”).
4. Post the updated calendar in a new message in reply to the message with the old calendar.
EPIX:
A little more detail from the call on the one patient in the slides...
The patient was treated with Aricept for more then 6 months (2 year history of Alzheimer's). The improvement was 5 points and as of today on drug for in 8 weeks.
Welcome I think if you are a long term holder you'll be happy. It seems whenever I have a fair amount of cash and Moro is in this price range I can't resist adding but I own a very good position as it is.
We'll also get the benefit of the most recent acquisition going forward which is good for a few cents. I believe Mr. Menard may still be looking at deals too and I have liked his track record.
Cramer's been touting it since high teen's I believe what makes now any different? I am Cramer in different in my ownership of stocks.
I think BMRN's price increase is related the surprise in pricing. I think that (more than) makes up for it being ahead of itself.
I can't say about short term price movement I am not a chartist but I'm happy about its longer term prospects.
EPIX:
Excuse the typos and some things I didn't quite catch on first listen
Slides: http://investor.epixpharma.com/phoenix.zhtml?c=91717&p=irol-calendar
Some notes from the call:
. Reason for Aricept lack of stat significance? No clear reason [expected remarks of: study not meant for efficacy, think will take longer for combo, etc.] Did say hypothesis is that Aricept patients may already have [didn't catch all of it] so effect more noticeable in monotherapy. Also pointed out no suggestion of dose trend.
. Monotherapy (30 patients total) 50mg, 150mg or placebo daily
. Combo (50 patients) 5, 25, 50, 100, 200 with Aricept 10mg/daily
. 2 AE's 1 heatburn (in monotherapy 150mg drop out), 1 fatigue. No reports of nausea, vomiting or diarrhea in Monotherapy
. Plan to initiate 2B 1H '08. Would expect to explore both Monotherapy and combo therapy in that though need to discuss with GSK
. Of the 10 patient 150mg monotherapy arm (1 dropped) 6 of 9 2 point or better ADAS-cog improvement, 2 of them 14 point [believe 2 where in the monotherapy]
. Anecdotal on 1 patient in combo and family noting significant improvement (improved 5 points on 100mg PRX-03140
in combination with Aricept)
. Dr. Solomon pointed out ADAS-cog typical change over 6 months 3-4 points which is noticeable to families. 6 points unusual. 3-4 points usually because placebo declines ~2 and drug up ~2.
. (Analyst pointing out) Aricept 2 weeks (.05 change in ADAS-cog and perhaps why no effect in combination).
. All 3 groups balanced to ADAS-cog (and other criteria). Nothing exceptional about 150mg group that could have predicted outcome.
. GSK Analyst Day discussed compound
12/17/07 Jobs@InterMune 10 positions http://www.intermune.com/wt/itmn/opportunities
Clinical:
Associate Director, Clinical Science – Pulmonary
Manager, Data Management (Hybrid —Clinical Data Manager and SAE Reconciler)
Drug Safety:
Associate Director, Drug Safety Risk Management (DSRM)
Information Technology:
Director, Information Technology
Sr. Database and Application Administrator
Medical Information:
Manager/Sr. Manager Medical Information
Research:
Research System Administrator
Scientist, Analytical Development
Senior Manager/ Associate Director, Pharmaceutical Development
Stability Coordinator /Manager
Once the phenylase program gets going
Not sure what you mean by "gets going" (IND approval, ramp, progress, etc.) but FYI the IND was filed. I keep forgetting the new name (PEG-PAL), on the 3rd quarter call Phil Nadeau asked Emil about Phase 2 progress data and while Emil wouldn't commit to having Phase 2 data by end of year '08 he did say some may be available. Should also be able to get some idea from the Phase 1.
http://biz.yahoo.com/prnews/071127/aqtu187.html?.v=19
The Phase I study will assess the safety and pharmacokinetics of single injections of PEG-PAL in approximately 35 PKU patients in a series of escalating dose cohorts. The patients in the Phase 1 study will be offered continuation into a Phase 2 study that will evaluate the safety and efficacy of weekly injections for eight weeks followed by a dose titration period. Preclinical data has demonstrated that PEG-PAL administered subcutaneously once weekly to PKU mice resulted in a sustained decrease in blood phenylalanine (Phe) levels in a twelve week study and has also shown potent Phe level reductions in primates.
Jump is based on pricing which was unexpected (high side). The cost will be 75k for avg. patient (Biomarin figure is 57k but for less then full compliance I believe they said 80% and I believe 15mg dose but I believe analyst dose more likely near 20mg) say AVG of 1000 patients gets to 75 million next year and Biomarin's projections...
(good) Problem is we already have 400 in expanded access and more likely to avg near 1.5 - 2k patients so closer to 100-150million 1 year out say spending doesn't jump drastically growth continues for Ald. & (especially) Nag. and we could be looking at close to .50 EPS and looking even better for '09 and Phenylase will move VERY fast (phase 2 could start mid '08).
Not looking too bad in my book!
Sorry this post was intended as a reply to Biowatch. But anyone who follows MEDX can answer.
Do you still like MEDX? I had them on a watch list for some time but never really delved into it. Plus they licensed one of their compounds for Pulmonary Fibrosis and I find that an interesting area. I was kinda hoping it would drop a bit more though. sorry nothing personal :)
Here is a link to a story with some videos including Roger's Lawyer making a presentation (3rd one)
http://sports.espn.go.com/mlb/news/story?id=3154625
I heard Justice come out and talk and while I am not 100% convinced he didn't use he put sufficient doubt to at least make me think that he could be telling us more truth then fiction.
I think Roger used something(s) and while it would be hard for me to believe otherwise these things would help. So to answer his lawyer here are some suggestion for him:
1-Have Clemens come out and talk himself.
2-Have Clemens take a public polygraph test (and don't do one privately and only release results if your happy with them).
3-Release ALL medical records and perhaps people with more of a background could determine has he healed from injuries in a natural way, has body fat/muscle mass been consistent with someone in his age over time, etc.
4-Explain to us what changed in Roger's regime to explain his rejuvenation of sorts.
Of course I don't expect them to do these things and instead say innocent till proven guilty, burden of proof not sufficient for prosecution, we can't prove a negative, Radomski lied to get off, blah blah blah...
BTW, in the first interview Mitchel points out Radomski would be further prosecuted if he provided false information and would not get any of the benefits. So I don't buy the argument he had a lot of incentive to provide excess false information.
Here is your answer...
Sorry I see someone else already posted this info. Moderator feel free to delete this post.
http://news.yahoo.com/s/ap/20071215/ap_on_sp_ba_ne/bbo_pettitte_hgh_admission_11
Pettitte admits using HGH during 2002
NEW YORK - Andy Pettitte used human growth hormone to recover from an elbow injury in 2002, the New York Yankees pitcher admitted two days after he was cited in the Mitchell Report. Pettitte said he tried HGH on two occasions, stressing he did it to heal faster and not enhance his performance. He emphasized he never used steroids.
"If what I did was an error in judgment on my part, I apologize," Pettitte said Saturday in a statement released by his agent. "I accept responsibility for those two days."
On Thursday, Pettitte was among 85 players named by former Senate Majority Leader George Mitchell's investigation into steroids and performance-enhancing drugs. Pettitte had not commented publicly on the allegations.
Pettitte asked the trainer he shared with Roger Clemens, Brian McNamee, to help him with HGH while on the disabled list early in the 2002 season, the report said. McNamee recalled injecting Pettitte two to four times, Mitchell said.
HGH wasn't banned by baseball until January 2005.
"In 2002 I was injured. I had heard that human growth hormone could promote faster healing for my elbow," Pettitte said in the statement released to The Associated Press by agent Randy Hendricks.
"I felt an obligation to get back to my team as soon as possible. For this reason, and only this reason, for two days I tried human growth hormone. Though it was not against baseball rules, I was not comfortable with what I was doing, so I stopped.
"This is it — two days out of my life; two days out of my entire career, when I was injured and on the disabled list," he said. "I wasn't looking for an edge. I was looking to heal."
Pettitte was not linked to steroids in the report, and said he never had never used them.
"I have the utmost respect for baseball and have always tried to live my life in a way that would be honorable," he said. "If I have let down people that care about me, I am sorry, but I hope that you will listen to me carefully and understand that two days of perhaps bad judgment should not ruin a lifetime of hard work and dedication.
"I have tried to do things the right way my entire life, and, again, ask that you put those two days in the proper context. People that know me will know that what I say is true," he said.
The Yankees backed Pettitte.
"Late this afternoon, Andy Pettitte advised us that he would be making a public statement. We support his coming forward," the team said in a statement.
The 35-year-old lefty is 201-113 lifetime. He started his major league career in 1995 and won four World Series championships with the Yankees. He pitched for his hometown Houston Astros from 2004-06 and helped them reach their first World Series.
Pettitte returned to the Yankees last season and went 15-9. This month, he put off retirement and agreed to a $16 million, one-year contract to play for the Yankees next season.
Mitchell devoted 1 1/2 pages to McNamee's testimony about Pettitte. Clemens was mentioned on nearly nine pages, with McNamee saying he injected the star pitcher.
Clemens was accused of using steroids and HGH and, through his lawyer, vehemently denied the accusations.
When Clemens joined the Yankees in 1999, he and Pettitte became fast friends and training partners. McNamee was part of their regimen — Clemens had worked with him in Toronto before being traded to New York.
According to the Mitchell Report, Pettitte asked McNamee about using HGH after the 2001 season, and the trainer said he discouraged the pitcher from trying it.
There is an interesting piece in todays WSJ that I though PP shareholders might misinterpret...
Before I tell you I need to give a disclaimer:
1-I support early access for critically ill patients with experimental therapies.
2-I think these stories are misleading because for every success they talk about there are likely main more failures that don't make the news. In addition the human body (and mind) are powerful things and there are cases of spontaneous remissions and recovers that would defy medical science.
3-I support well done clinical studies to prove efficacy of therapies. Anecdotal cases of success while heart-warming to hear don't show efficacy.
OK with that out of the way [please keep it in mind though] the front page story in today's WSJ (saturday), sorry I don't have on-line access to post it titled "Lab Rat?" by Geeta Anand talks about a fathers search for experimental (to some extent home brewed coctails) to treat his sons untreatable cancer. In it one of the many drugs the father has used is tetrathiomolybdate (though I think an anti-copper drug in general is what was being sought). I was actually surprised as I thought there would be no way to get access to the drug?
Its a nice long story but hopefully Steve Kanzer doesn't come out Monday with a PR about Coprexa shown to cure cancer!
I guess Congratulations are in order Biowatch!
Thanks appreciate your comments.
My thinking on the BIIB investment bankers was more to get Ican off their back then really wanting to sell. I was a Visx shareholder when Ican came along (didn't do so well) but management was distracted and eventually sold off after Ican to Advanced Medical Optics I think they wanted the EYE ticker :).
I doubt that Tysabri will become a blockbuster
Dew am curious as to your disdain (too harsh?) for Tysabri is it the risk of PML? Oral therapies on the Horizon? Belief in Copaxone or the Interferons as better therapy? All/Something Else? TIA
I heard a talk recently where they said some Japanese docs (or studies I can't recall which) were talking about using anticoagulants to help treat Pulmonary Fibrosis. There were some reasons behind trying it (don't recall from memory) the docs talking about it described it as interesting so it is certainly very early stage and perhaps just hypothesis generating at this point.
As to market opportunity, IMHO, I think Pulmonary Fibrosis is the biggest unmet Orphan disease and even a mediocre treatment will do well.
I don't know them either (never had contact with the company) looking through filings and how each division is doing (by memory) I believe it is the younger son is in charge of the Skincare division and it is doing quite well they talk about the Sirius division having a lot of potential but it seems to be declining (though it is quite small). Wonder if that is more management or product related?
I like the potential of the company. It has nice stable growth (overall) so I don't see much downside risk too. Would follow it a lot closer if I could get some decent shares (I try not to chase stocks though).
57K is much higher then anyone expected! The down side is that in some past calls JJ had eluded to people with PKU for some time (older patients) may not be immediately helped (wonder if that was eluding to possible reimbursement difficulties?).
Co discloses that on December 13, 2007, BMRN issued a press release regarding the granting of marketing approval for Kuvan (sapropterin dihydrochloride) by the U.S. Food and Drug Administration... On a conference call to be held on Thursday, December 13, 2007 at 5:00 p.m. ET, related to the press release, the co will describe that BioMarin's list sale price for Kuvan is $0.29 per mg, which BioMarin believes will result in an average annual cost of therapy of $57,000 per patient, based on certain assumptions that will be discussed on the call. BMRN expects 2008 Kuvan revenue to be in the range of $35-70 mln.
Wow 57k avg. price!!!
I was disappointed to see the buyback.... Or at least they could have waited a while till I built up a decent position.
Unless they purchases are via private transaction I can't see them buying anywhere near 1% much less 10%! But still just having it out there probably prevents any more cheap shares anytime soon.
So will players who were named start naming other players?
In the Bonds case I think people will point to changes in Physical characteristics (head and not just ego) and substantial body mass/muscle increase along with generally a player in his mid 30's is declining not improving.
On Frank Thomas I liked him as a player (though he may have taken a few too many walks considering he was paid to drive in runs :) ) and in his defense his stats while up and down generally declined with age.
IMHO I'll doubt any player whose stats went up or whose size increased substantially/suddenly. It seems only natural now to doubt everyone it may not be accurate or fair but who said life was fair :).
While Mitchel denied any conflict with being on Boston's board. A yankee fan could protest that the report is unduly critical of past/current Yankees? In fairness I think the sources Mitchel had just led to that.
WFAN is really stressing Clemens. I guess Barry Bonds will be happy to get some of the heat off. I think Clemens will become the new Enemy #1
Somewhere, somebody needs to give a big tip of the cap to Frank Thomas. A guy who played clean, and who had the decency not to cave in to the thuggish Omerta of the Union and the pro-doper thugs.
How do you know he played clean? Not to be picky but my contention is we can't know who is "clean" unfortunately we can get a very good idea of who isn't.
I agree about the general message of your post though. It'll be interesting (well maybe blood-pressure raising is more accurate) to hear Donald Fehr later today.
I think a lot of people expected it.
I'll be curious to hear the conference call and see if their is a (lower bound) age mention and of course the pricing information. No doubt it will be per pill. My guess the 20mg dose (which I think most will end up near) will be in 30-35k/yr range.
Along those lines...
Kuvan was approved for PKU, Biomarin will have a conference call at 5:00pm. I am curious about the label for the (low end of the) age range. Interestingly the PR states about starting on 10mg for a month then going to 20mg. Initial I thought that patients may only be on for 1 month to see if they respond.
Ticker is going crazy. Is it possible we won't have to wait till friday PM?
Thanks!
Do you have a link for where you got those names? TIA