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<<UK’s NICE Caps Cumulative Reimbursement for Lucentis >>
Interesting. This could be considered potentially bullish for REGN's AMD drug under development (if eventually approved) since it may only require 1 shot every two months rather than monthly as prescribed for Lucentis.
Regeneron eyes drugs for heart, diabetes, asthma
Wed Dec 12, 2007 2:54pm EST
NEW YORK, Dec 12 (Reuters) - The chief executive officer of Regeneron Pharmaceuticals Inc (REGN.O: Quote, Profile, Research) on Wednesday said the company is interested in widening its focus to possible treatments for cardiovascular problems, diabetes, asthma and allergy.
"We are looking more broadly with our resources and the cardiovascular area is certainly an area we have an interest in, and we can certainly also develop antibodies that might address diabetic conditions," as well as asthma and allergy, Leonard Schleifer said in an interview.
Regeneron, whose genetically modified mice produce fully human antibodies capable of blocking disease-causing proteins, has already begun preclinical trials of possible drugs to treat diabetes, asthma and allergy, Schleifer said.
Schleifer said Regeneron expects to have cash reserves of about $850 million by the end of 2007, which he described as a comfortable cushion given that the company "burns" only $50 million to $100 million a year for research and related expenses.
In addition to developing more drugs of its own, Schleifer noted that Regeneron is obligated to put two to three new medicines into clinical trials each year under an $872 million drug-development deal reached late last month with French drugmaker Sanofi-Aventis (SASY.PA: Quote, Profile, Research). (Reporting by Ransdell Pierson, editing by Gerald E. McCormick)
http://www.reuters.com/article/marketsNews/idUKN1264293320071212?rpc=44
MNTA - movement after 30 days tax loss selling on Nov. 6th?
http://finance.yahoo.com/q/bc?s=MNTA&t=3m&l=on&z=m&q=l&c=
Could be one of the reasons for strong interest beginning yesterday??
OT: My only biotech shelter right now is REGN
Tough day today for us longs. This sharp of a decline will unfortunately also cause retail holders on margin to sell shares too. Not sure how long this will pressure the stock.
cleverrox, I was just asking "doc" in his own words (from earlier message) whether he was buying more rprx during this selloff that occurred this morning when someone dumped around 40k shares. Sorry if you misunderstood my comments. I wasn't making fun or criticizing anyone on this board, nor do I ever have a record of being a bad poster.
Wholesale dump going on now. Is the hoover vacuum cleaner working this morning doc??
RPRX -- dewophile, then the question one might ask is whether Joe P. will seriously consider a sale of the company once they complete their nearterm anemia trial, and initiate their longer term chronic trial for UF? And, does the outcome of this FDA meeting derisk further the company's asset value to potential buyers?
I believe most longs knew that chronic P3 UF trials would take longer. FDA's response appears even more conservative, but that isn't surprising in the current environment.
I agree net result from FDA meeting was positive, especially for longer term investors. Anemia trial should give the Street some confidence that the company is finally reaching some of its goals for getting a drug approved for one of the Proellex indications (the newer one). I think this is very exciting news for the company to build upon.
reid_4,
Regarding this point you brought up:
"On the issue of the Nov. 30 meeting, Joe P. sounded very confident. The most significant question will be the number of patients the FDA will require for the Phase III chronic fibroid trial and open label studies."
Is the cumulative number of patients for safety on UF chronic trials (1500 by FDA) considered good, ok, bad news? Thanks for others thoughts on this particular point from this morning's PR.
Repros' Lead Product Proellex to Enter Phase 3 for the Treatment of Uterine Fibroid Indications
Monday December 3, 6:00 am ET
Live Conference Call December 4th at 12:00 p.m. Eastern Time
THE WOODLANDS, Texas--(BUSINESS WIRE)--Repros Therapeutics Inc. (NasdaqGM:RPRX - News) today announced the outcome of its Type B meeting held with the Food and Drug Administration (“FDA”) on November 30, 2007. The purpose of this meeting was to review results from the clinical trials of Proellex® conducted to date and to discuss the initiation of Phase 3 studies. In addition, Repros also discussed conducting clinical trials for a new indication as a short course treatment of anemia due to excessive menstrual bleeding associated with uterine fibroids (“uterine fibroid-induced anemia”).
During the course of the meeting the FDA agreed that Proellex, indicated as a presurgical treatment for the correction of anemia associated with excessive bleeding due to the presence of uterine fibroids, is acceptable. The agency suggested that this indication would be best considered under a separate IND. Repros will submit an IND to commence two pivotal Phase 3 studies for the indication as soon as possible. Each study will consist of 75 patients comparing 25 and 50 mg Proellex to placebo for 3 months in a double blind fashion. The primary endpoint will be the comparative change of hemoglobin in the Proellex and placebo treatment groups. Additional clinical safety data will be obtained from other ongoing and planned Proellex studies in at least 100 patients who have been exposed to Proellex for at least 6 months. In the recently completed Phase 2 uterine fibroid study of Proellex, the drug achieved a statistically significant increase in hemoglobin as compared to placebo at the end of the 3 month study (p < 0.003).
Andre van As, M.D., Ph.D., the Company's Senior VP of Clinical and Regulatory Affairs, said, "Based on our meeting with the FDA, uterine fibroid-induced anemia is a new indication for Proellex which is a realistically achievable goal for what we believe is a best-in-class selective progesterone receptor modulator. We are excited about this new opportunity and look forward to commencing our pivotal Phase 3 clinical trials for this indication, during the first quarter of 2008. Based on this aggressive plan, we anticipate being in a position to file our NDA with the FDA for this first indication by the end of 2008."
The FDA also provided a preliminary review for Repros’ plans for Phase 3 pivotal efficacy protocols for the chronic treatment of symptoms associated with uterine fibroids. The FDA agreed that the pivotal clinical trials will consist of 2 four-month double blind placebo controlled studies. The FDA concurred that the concept of off-drug periods (drug holidays) between treatment periods is acceptable. The FDA in addition requires long-term safety studies of at least 200 patients for a minimum period of one year on drug, which incorporating off drug periods, could last between sixteen and twenty-four months in total, with the final duration of drug exposure to be determined by the FDA as data from ongoing studies continues to evolve. For this chronic indication, the FDA suggested a safety data base of 1500 patients which may be derived from studies of Proellex for all indications, doses and durations of exposure. Repros has suggested the use of a quality of life instrument (UFSQOL) as a potential primary endpoint for the pivotal studies in the future. In the recently completed Phase 2 uterine fibroid study, the UFSQOL indicated Proellex achieved a clinically and statistically highly significant improvement in symptom severity (p<0.0001). Repros will submit Phase 3 protocols for FDA review in the first Quarter of 2008 and plans to commence these Phase 3 studies shortly thereafter.
Joseph Podolski, President and CEO of Repros, stated “I am pleased with the outcome of the Type B meeting with the FDA. We look forward to commencing our pivotal programs for Proellex. Our current cash of $26.7 million allows us to commence these studies in an aggressive fashion.”
Repros Conference Call
Repros management will hold a conference call to discuss the company's future product clinical development plans for Proellex in the treatment of uterine fibroid-induced anemia, uterine fibroids and endometriosis, and to answer investor questions. The call will be held at 12:00 p.m. Eastern Time on December 4, 2007. Investors can access the call by dialing 866-322-1159 (within North America) or 416-640-3404 (International).
You can access a replay of the taped conference call approximately 2 hours after the completion of the conference call until approximately 12:00 p.m. Thursday, December 6, 2007, by dialing 888-203-1112 (North America) and 647-436-0148 (International). The passcode is 3483523. You can also access the replay via our website at www.reprosrx.com.
About Repros Therapeutics Inc.
Repros Therapeutics Inc. is engaged in the clinical development of small molecule therapeutics for the treatment of reproductive system disorders that have significant market potential and are currently underserved. We are developing our lead product Proellex®, which is a selective blocker of the progesterone receptor, for the treatment of uterine fibroids, endometriosis and as a short course treatment for uterine fibroid-induced anemia. Uterine fibroids affect numerous women of childbearing age in the U.S. and result in a significant number of hysterectomies each year and endometriosis is a condition that affects approximately 5.5 million women in the U.S. and Canada.
Repros recently completed a three-month U.S. Phase 2 clinical trial of Proellex for the treatment of symptoms associated with uterine fibroids and patients from that study have been enrolled into a one-year open-label safety study. We intend to initiate pivotal Phase 3 clinical trials for the treatment of uterine fibroids and for the treatment of uterine fibroid-induced anemia in the first quarter of 2008 and anticipate filing a NDA for the anemia indication by year-end 2008. Repros also recently completed a Proellex six-month European Phase 1/2 clinical trial for the treatment of symptoms associated with endometriosis, and has initiated a U.S. Phase 2 study for this indication in the third quarter of 2007.
Our second drug candidate, Androxal™, is designed to restore normal pituitary response resulting in normalization of testosterone levels. According to the Urology Channel, recent estimates show that approximately 13 million men in the United States experience testosterone deficiency. Repros recently completed an Androxal non-pivotal six-month U.S. Phase 3 clinical trial and has enrolled patients from this trial into a one-year open-label safety study. We intend to develop Androxal™ for the treatment of fertility preservation and improvement in patients that want to preserve their fertility while being treated for low testosterone associated with secondary hypogonadism. In addition, we also intend to develop Androxal for the treatment of men with idiopathic adult onset hypogonadotropic hypogonadism associated with glycemic and lipid dysregulation.
For more information, please visit the Company's website at http://www.reprosrx.com.
Any statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including Repros’ ability to have success in the clinical development of its technologies, the timing of enrollment and release of data in such clinical studies and the accuracy of such studies, limited patient populations of clinical studies to date and the possibility that final data may not be consistent with interim data, Repros' ability to raise additional capital in a timely manner and on acceptable terms or at all and such other risks which are identified in the Company's Annual Report on Form 10-K for the year ended December 31, 2006 and Repros’ Quarterly Reports on Form 10-Q for the quarters ended March 31, June 30, and September 30, 2007, as they may be updated by the Company’s Exchange Act filings from time to time. These documents are available on request from Repros Therapeutics or at www.sec.gov. Repros disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Contact:
Repros Therapeutics Inc.
Joseph S. Podolski, 281-719-3447
President & CEO
--------------------------------------------------------------------------------
Source: Repros Therapeutics Inc.
http://biz.yahoo.com/bw/071203/20071203005415.html?.v=1
Repros' Lead Product Proellex to Enter Phase 3 for the Treatment of Uterine Fibroid Indications
Monday December 3, 6:00 am ET
Live Conference Call December 4th at 12:00 p.m. Eastern Time
THE WOODLANDS, Texas--(BUSINESS WIRE)--Repros Therapeutics Inc. (NasdaqGM:RPRX - News) today announced the outcome of its Type B meeting held with the Food and Drug Administration (“FDA”) on November 30, 2007. The purpose of this meeting was to review results from the clinical trials of Proellex® conducted to date and to discuss the initiation of Phase 3 studies. In addition, Repros also discussed conducting clinical trials for a new indication as a short course treatment of anemia due to excessive menstrual bleeding associated with uterine fibroids (“uterine fibroid-induced anemia”).
During the course of the meeting the FDA agreed that Proellex, indicated as a presurgical treatment for the correction of anemia associated with excessive bleeding due to the presence of uterine fibroids, is acceptable. The agency suggested that this indication would be best considered under a separate IND. Repros will submit an IND to commence two pivotal Phase 3 studies for the indication as soon as possible. Each study will consist of 75 patients comparing 25 and 50 mg Proellex to placebo for 3 months in a double blind fashion. The primary endpoint will be the comparative change of hemoglobin in the Proellex and placebo treatment groups. Additional clinical safety data will be obtained from other ongoing and planned Proellex studies in at least 100 patients who have been exposed to Proellex for at least 6 months. In the recently completed Phase 2 uterine fibroid study of Proellex, the drug achieved a statistically significant increase in hemoglobin as compared to placebo at the end of the 3 month study (p < 0.003).
Andre van As, M.D., Ph.D., the Company's Senior VP of Clinical and Regulatory Affairs, said, "Based on our meeting with the FDA, uterine fibroid-induced anemia is a new indication for Proellex which is a realistically achievable goal for what we believe is a best-in-class selective progesterone receptor modulator. We are excited about this new opportunity and look forward to commencing our pivotal Phase 3 clinical trials for this indication, during the first quarter of 2008. Based on this aggressive plan, we anticipate being in a position to file our NDA with the FDA for this first indication by the end of 2008."
The FDA also provided a preliminary review for Repros’ plans for Phase 3 pivotal efficacy protocols for the chronic treatment of symptoms associated with uterine fibroids. The FDA agreed that the pivotal clinical trials will consist of 2 four-month double blind placebo controlled studies. The FDA concurred that the concept of off-drug periods (drug holidays) between treatment periods is acceptable. The FDA in addition requires long-term safety studies of at least 200 patients for a minimum period of one year on drug, which incorporating off drug periods, could last between sixteen and twenty-four months in total, with the final duration of drug exposure to be determined by the FDA as data from ongoing studies continues to evolve. For this chronic indication, the FDA suggested a safety data base of 1500 patients which may be derived from studies of Proellex for all indications, doses and durations of exposure. Repros has suggested the use of a quality of life instrument (UFSQOL) as a potential primary endpoint for the pivotal studies in the future. In the recently completed Phase 2 uterine fibroid study, the UFSQOL indicated Proellex achieved a clinically and statistically highly significant improvement in symptom severity (p<0.0001). Repros will submit Phase 3 protocols for FDA review in the first Quarter of 2008 and plans to commence these Phase 3 studies shortly thereafter.
Joseph Podolski, President and CEO of Repros, stated “I am pleased with the outcome of the Type B meeting with the FDA. We look forward to commencing our pivotal programs for Proellex. Our current cash of $26.7 million allows us to commence these studies in an aggressive fashion.”
Repros Conference Call
Repros management will hold a conference call to discuss the company's future product clinical development plans for Proellex in the treatment of uterine fibroid-induced anemia, uterine fibroids and endometriosis, and to answer investor questions. The call will be held at 12:00 p.m. Eastern Time on December 4, 2007. Investors can access the call by dialing 866-322-1159 (within North America) or 416-640-3404 (International).
You can access a replay of the taped conference call approximately 2 hours after the completion of the conference call until approximately 12:00 p.m. Thursday, December 6, 2007, by dialing 888-203-1112 (North America) and 647-436-0148 (International). The passcode is 3483523. You can also access the replay via our website at www.reprosrx.com.
About Repros Therapeutics Inc.
Repros Therapeutics Inc. is engaged in the clinical development of small molecule therapeutics for the treatment of reproductive system disorders that have significant market potential and are currently underserved. We are developing our lead product Proellex®, which is a selective blocker of the progesterone receptor, for the treatment of uterine fibroids, endometriosis and as a short course treatment for uterine fibroid-induced anemia. Uterine fibroids affect numerous women of childbearing age in the U.S. and result in a significant number of hysterectomies each year and endometriosis is a condition that affects approximately 5.5 million women in the U.S. and Canada.
Repros recently completed a three-month U.S. Phase 2 clinical trial of Proellex for the treatment of symptoms associated with uterine fibroids and patients from that study have been enrolled into a one-year open-label safety study. We intend to initiate pivotal Phase 3 clinical trials for the treatment of uterine fibroids and for the treatment of uterine fibroid-induced anemia in the first quarter of 2008 and anticipate filing a NDA for the anemia indication by year-end 2008. Repros also recently completed a Proellex six-month European Phase 1/2 clinical trial for the treatment of symptoms associated with endometriosis, and has initiated a U.S. Phase 2 study for this indication in the third quarter of 2007.
Our second drug candidate, Androxal™, is designed to restore normal pituitary response resulting in normalization of testosterone levels. According to the Urology Channel, recent estimates show that approximately 13 million men in the United States experience testosterone deficiency. Repros recently completed an Androxal non-pivotal six-month U.S. Phase 3 clinical trial and has enrolled patients from this trial into a one-year open-label safety study. We intend to develop Androxal™ for the treatment of fertility preservation and improvement in patients that want to preserve their fertility while being treated for low testosterone associated with secondary hypogonadism. In addition, we also intend to develop Androxal for the treatment of men with idiopathic adult onset hypogonadotropic hypogonadism associated with glycemic and lipid dysregulation.
For more information, please visit the Company's website at http://www.reprosrx.com.
Any statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including Repros’ ability to have success in the clinical development of its technologies, the timing of enrollment and release of data in such clinical studies and the accuracy of such studies, limited patient populations of clinical studies to date and the possibility that final data may not be consistent with interim data, Repros' ability to raise additional capital in a timely manner and on acceptable terms or at all and such other risks which are identified in the Company's Annual Report on Form 10-K for the year ended December 31, 2006 and Repros’ Quarterly Reports on Form 10-Q for the quarters ended March 31, June 30, and September 30, 2007, as they may be updated by the Company’s Exchange Act filings from time to time. These documents are available on request from Repros Therapeutics or at www.sec.gov. Repros disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Contact:
Repros Therapeutics Inc.
Joseph S. Podolski, 281-719-3447
President & CEO
--------------------------------------------------------------------------------
Source: Repros Therapeutics Inc.
http://biz.yahoo.com/bw/071203/20071203005415.html?.v=1
Thanks dewophile. fyi I emailed your info to Joe P.
PS: Nice MM headfake to 9.64 before the close up on volume to 9.84 at the high today. ;)
My Schwab just showed JAV as being Halted.
Anyone have a newswire feed on pending news?
This may be a Schwab glitch, as it is now showing the SPY symbol being halted.
Sanofi mulls biotech buy on top of Regeneron stake
Thu Nov 29, 2007 4:15am EST
PARIS, Nov 29 (Reuters) - Sanofi-Aventis (SASY.PA: Quote, Profile, Research) does not rule out buying a biotechnology firm, it said on Thursday, after it revealed it had raised its stake in U.S. biopharmaceutical company Regeneron <REGN.O.
"The investment in Regeneron is part of the group strategy and does not exclude the possible acquisition of a biotechnology firm as indicated in September," a spokesman for the world's number four pharmaceuticals group said on Thursday. (Reporting by Noelle Mennella, editing by Will Waterman)
http://www.reuters.com/article/marketsNews/idUKWEB964320071129?rpc=44
REGN: Now I understand why the share price was getting held down yesterday during a huge market rally. ;)
Someone bought some 17.5, 20 and 22.5 calls for Dec. (around 70 contracts each). Cha Ching!
Pre-market: up 40% $24!
High testosterone linked to men's lower death risk By Will Dunham
Mon Nov 26, 4:06 PM ET
http://news.yahoo.com/s/nm/20071126/hl_nm/testosterone_heart_dc_1
I just found this posted by Dew on the IHUB BV board
WASHINGTON (Reuters) - Higher naturally occurring levels of the male hormone testosterone appear to protect men from fatal heart attacks or strokes and death from all manner of causes, researchers in Britain said on Monday.
But the researchers cautioned men not to begin testosterone supplementation based on the results of this 10-year study, saying the benefits and risks are unclear.
The role of testosterone in men's health is controversial, with the relationship between men's natural testosterone levels and overall health not well understood, according to the researchers.
But this study led by Dr. Kay-Tee Khaw, a professor of clinical gerontology at the University of Cambridge School of Clinical Medicine in Britain, found strong benefits in men with higher natural levels of the hormone.
Men in the upper 25 percent of natural testosterone levels had a 41 percent lower risk of dying from heart attack, stroke and other cardiovascular conditions, cancer and all other causes, compared to men with the lowest levels, the researchers found.
"Low testosterone seems to predict increased risk of total mortality in cardiovascular disease as well as cancer," Khaw said in a telephone interview.
The researchers tracked 11,606 British men ages 40 to 79 who had no known cancer or cardiovascular disease at the start of the study. They joined the study from 1993 to 1997 and were followed until 2003.
Among these men, 825 died during the study period. The researchers measured their testosterone levels using frozen blood samples provided earlier, and compared their levels to a group of men still alive at the end of the study period.
Khaw said the relationship between testosterone levels and cardiovascular disease mortality was comparable in magnitude to well-established risk factors like high blood pressure and cholesterol levels.
Thus, low testosterone levels could point to men at elevated risk for cardiovascular death who may not have other known risk factors, the researchers reported in the journal Circulation.
Khaw said the findings suggest that men with low levels of testosterone might be able to cut their risk of death with testosterone supplementation, but did not recommend doing this without more research backing up these results.
She pointed to the experience involving hormone therapy in women. Early studies suggested hormone therapy could protect post-menopausal women from heart disease, but later and larger research yielded the opposite results.
"The anxiety about testosterone supplementation is that high testosterone may be a risk factor for prostate cancer," added Khaw, who noted that the study looked only at naturally occurring levels of the hormone and not supplementation.
Testosterone is the primary "male" hormone that helps maintain muscle mass and strength, fat distribution, bone mass, sperm production, sex drive and potency. Women have testosterone too, but at lower levels.
Doctors have used testosterone therapy to treat men with abnormally low testosterone levels. Some athletes and bodybuilders use it to promote muscle mass and strength.
(Editing by Cynthia Osterman)
Crou, I agree that there has been tax loss selling the past week, and some general fear regarding the upcoming FDA meeting. Looks like the sellers are done for now, and a nice bid is back on the stock.
io_io, I think he meant to say Androxal, not Androgel in his last post.
Yesterday there was a large bid at 3.96
Today there is a large ask (476) at 3.85
Looks like more end of year tax selling.
OT: SSRX
I don't follow it but I hope you shorted it above $17, as its up 17% (16.8) in afterhours.
http://finance.yahoo.com/q?s=ssrx
Regarding stock movement: I don't think anyone can say with confidence that the recent reversal was due only to David Miller's report. The two presentations last week may have resulted in a mixed reaction (some retail selling), but obviously someone was buying the shares from the 12's down to 9.7's, and throughout the reversal into the mid-10's.
It is nice though to see some interest again in the stock after the bloodletting the past week. ;)
WAG 12/04/2007 9:20 pm
Exactly 47 years after I entered the earth's atmosphere.
I expect to celebrate with some of the WAG cash prizes. ;)
Spartex
Mark, I assume the "biotech stock research" update was positive in light of today's trading. Nice to see money move from energies back into biotech, banks and some tech's.
I also don't understand an FDA argument that says Androxal needs to have additional endpoints to move into the T space. The key to reviewing a new drug (and MOA) imo is that it works as well, and even better than current drugs. Androxal has the efficacy and also the lack of side effects of currently approved T drugs. What am I missing? Politics?
I would think that a European partner would make even more sense so now so that the drug can get into the European and even Japanese market. Thoughts?
I've noticed that RPRX is getting low volume accumulation (past week), even during the market sell off like today. Looks bullish imo.
<if I could sell right here at $5, I would, but there's now way in hell I could get out of 200k shares anywhere near the price its at now.>
Where were you yesterday when the volume was over 1.2 mil shares and price over $5.3??? ;) You could have gotten rid of 100k+ shares no problem.
Insulin produced inside lettuce cells. Thanks Dew, I also just reread this article.
What I find funny is the quote in the article is from UCF Professor Henry Daniell, and not the writer's words. And, Daniell says this methodology would "not simply provide temporary relief", which is also a strange use of words. Insulin provides blood sugar treatment/management, but has to be administered each day and at specified times for meals. So in some ways my insulin injections do provide temporary relief, but I need to use it daily to treat my condition over the long term. I would assume the same would hold true for this lettuce. Now I hope he is using a tasty species of lettuce so people will actually eat it! :)
"Once it's put inside the plant cell and when it's ingested in the stomach, that plant cell is surrounded by a cell wall and the cell wall protects it from amino acids in the stomach and also from enzymes for digesting. However, when the plant cell reaches the gut, bacteria poke holes in the plant cell wall and release the insulin and that is when it is absorbed. When this is absorbed we anticipate that this methodology would cure diabetes and not simply provide temporary relief," said UCF Professor Henry Daniell.
Daniell expects clinical trials to begin soon. The next step would be FDA approval.
Dew, any comments on this insulin research finding?
http://www.cfnews13.com/News/Local/2007/8/1/making_insulin_inside_lettuce.html
I can't quite understand how it would cure a Type I diabetics condition, other than providing a new way to administer insulin, but how would this allow a diabetic to regain their beta islets cells in the pancreas???
If Jimmy Rogers thinks we're now in a recession, shouldn't that be the time to buy US dollars and/or stocks?? IOW, but at the bottom, not the top! ;)
I sent Joe P. (CEO) an email regarding updates or conf calls on their Androxal trial plans following the Oct 15 FDA meeting. He said that he'll be "presenting at both the Rodman and CIBC conferences the week of November 5. I will be providing more information at that time. Both presentations will be webcast."
They aren't planning on having any conf calls following the Oct 15 meeting with FDA at this time.
Bio_pete, do you have an email address I can email you on?
Not sure if you still have my yahoo email.
Low testosterone in men linked to earlier death By Amy Norton
Tue Oct 23, 3:53 PM ET
Thanks markvi62 for that link! Interesting implications and potential support for increased application for drugs like Androxal in this population.
NEW YORK (Reuters Health) - Older men with low levels of the hormone testosterone may die sooner than other men their age with normal testosterone levels, a study suggests.
Researchers found that among 794 generally healthy older men, those with the lowest testosterone levels were 40 percent more likely to die within the 1985-2004 study period.
The findings do not mean, however, that older men should start taking testosterone supplements to achieve a longer life, the study authors are quick to point out.
The study shows only an association between low testosterone and earlier death -- not a cause-and-effect relationship, lead author Dr. Gail A. Laughlin told Reuters Health. What's more, there was no evidence that having above-average testosterone levels gave men any longevity advantage.
"We cannot recommend that any man take testosterone based on these results," Laughlin stressed.
She and her colleagues at the University of California, San Diego, report their findings in the Journal of Clinical Endocrinology & Metabolism.
In theory, low testosterone could affect older men's longevity through metabolic effects. Some past studies have found that low testosterone can precede the development of abdominal obesity and the metabolic syndrome -- a collection of risk factors for diabetes and heart disease that includes obesity, high blood pressure and unhealthy cholesterol levels.
In their study, Laughlin and her colleagues found that low testosterone was associated with abdominal obesity and aspects of the metabolic syndrome, but when these factors were excluded, low testosterone remained independently linked to earlier death.
The study included 794 men between 50 and 91 year old (average age 73.6 years) who were followed for an average of 11.6 years. Overall, the one quarter with the lowest testosterone levels at study entry were 40 percent more likely to die over the course of the study than men with higher levels of the hormone.
There is some disagreement among experts on how to define overt testosterone deficiency, with some saying it should be diagnosed when levels fall below 300 nanograms per deciliter (ng/dL) and others advocating lower cutoffs.
There was no evidence in this study that raising older men's testosterone above 300 ng/dL might boost survival, according to Laughlin's team.
This finding offers "no support for widespread testosterone therapy for aging men," the researchers write.
Indeed, it's unclear whether raising testosterone in men with a clear deficiency can safely prolong life. Only clinical trials that test hormonal supplementation against a placebo can answer this question, Laughlin said.
SOURCE: Journal of Clinical Endocrinology & Metabolism, October 2007.
io_io, lol. I read all posts on this MB. But that stuff goes in my eyeballs and then into the neural trash bin. ;) iow, non-essential chatter.
io_io, well I can only follow along so many things in my life. ;)
While I think it is a good thing that shorts are covering according to nasdaq updates, I am more interested to see more funds going long on RPRX based on their fundamentals.
Nerf, why do you say that??
I'm wondering if the 60k afterhours trade was from shares accumulated during the day by MM's for a specific client who is a "buyer" going long. That's not to say someone could be doing this to close out a short position too. I just don't know but I hope JP's meetings in Europe went well. I am curious of the timeframe for their conf call update on androxal.
RPRX afterhours shows 60k at $12.62 at 4:26 pm
16:26 $ 12.62 60,000
16:17 $ 12.5402 1,000
16:09 $ 12.6155 2,100
1
Thomas, do you know whether manufacturing for Dyloject is much of a concern/risk? I bought more JAV on Wed at around 4.7's.
Thanks for anyones thoughts on the manufacturing area and whether that's much of a risk at this point in the UK's review.
RPRX - David Miller
Corpstrat's answer of "the conference call" provided me a reference point to understand his point of view here, thereby allowing me an insight into what other market participants are thinking in bidding up the company stock based upon this news, when they haven't bid up the stock of this woefully undervalued company based on news I believe is arguably less 'nuanced'.
David, imo, I believe the reason RPRX was bid up almost $2 bucks yesterday was relief that FDA wasn't going to require the QOL endpoints, not necessarily from the details of RPRX's PR. My guess posted here on IHUB was we'd only go up a $1. If the FDA had said RPRX would only require T endpoint in one P3 pivotal trial, I speculate that the stock would have opened $12+ and moved to $14-15 price range. That said, I am hoping/believe that the street will continue to bid up the price of the stock based on the other "arguably less 'nuanced'" data that RPRX has reported already on Proellex, and the fact that the management still appears to be managing their FDA discussions and trials very well.
I haven't talked to management after the FDA meeting, but it would be my belief that in the discussions with the FDA their first stance was to try and get T endpoint only, and then if the FDA said "no" you still need to do QOL, Joe brought in his backup plan B which included these other endrocrine elements (as discussed on the conf call before meeting). Sounds like it was played out very strategically imo.
Charmed, from your summary of discussion with management, I'm wondering what this will do in terms of the cash needs of RPRX as it relates to covering costs of Androxal and Prollex trials in 2008 going forward? I wonder if they will still consider just selling the entire Androxal part of their company rather than work through all of these trials?
Thanks for your summary!
This is when I will pounce and add to my shares because I am also convinced that anything under $15 is a steal now
Where were you at the open, lol? I was buying some additional shares in the $11's until it got to 11.75. I'm done for now.
Doesn't look like there is much validity to daytraders pulling out after 3 pm today. They may have already pulled out earlier in the day. Looks like stock is holding nicely.