I guess the dreams of $60 share buy-outs are long past. I don't know whose to blame. The company lost momentum a long time ago and can't get it back.

I wouldn't be disappointed in an auction at this point, but I doubt JP is willing to give away the company. We need to do some creative financing with a pharma partner. Give us $50 million for a 20% stake and an option to buy us at a later date.

I'm surprised at the substantial placebo effect seen in the groups. The data looks great, but I'm wondering if it would have looked even better with a larger population.

FDA revises process for responding to drug applications
Under new regulations that govern the drug approval process, FDA's Center for Drug Evaluation and Research will no longer issue "approvable" or "not approvable" letters when a drug application is not approved. Instead, CDER will issue a "complete response" letter at the end of the review period to let a drug company know of the agency's decision on the application.

From the Flyonthewall.

Y3maxx, I don't care if Efficacy trades the stock. I would imagine all of us have traded shares in POZN so why can't the biggest shareholder make a few bucks.

The 13D/A filing states:

"The sales of Common Stock listed in Item 5 were involuntary sales effected without notice by the Reporting Persons’ prime broker, Fidelity Capital Markets Services, a division of National Financial Services LLC (“Fidelity”), acting unilaterally and without direction from or authority provided by the Reporting Persons."

I realize that some of the funds are not US, but that doesn't mean their "didling" us.

re: JAV

Its my understanding that a lot of pressure has been placed on the new management to find a buy-out offer. They keep changing the game plan every few months, but this looks like the best case scenario. Top-line data on Dyloject's Phase III will be reported late 3rd qtr. The company will then hire a bank to solicit offers. If they can't find a buyer then it will look like another MBRK.

I predict the company will report less then $200K for Dyloject sales in the 2nd qtr & the stock may break $2 a share. The stock should trend back to the $2.50 area as we wait for Phase III data (extremely low chance of negative results) and may trade over $3.00 once the results are released.

what's "diddling"?

Ask y3maxx, I just copied his post, but if I had to guess then it means he's f-ing us. Do you know what that means?

"Mark and his cronies have been didling us retail longs"

Why do you think he's been trading shares? Couldn't it just be a margin call?

Thanks for the update. I wouldn't be surprised if RPRX plans to present the new data to the FDA once the trial is completed and ask if they can gain approval for Androxal based on this new endpoint.

IMMUNOSYN CORPORATIN(OTC BB: IMYN.OB) The stock is up 50% in the last two days trading and has a market cap of $829 million. This has to be the most overvalued biotech eventhough its only trading at $3.05. There is a huge market opportunity for their drug, but it must be 15 years away from ever gaining approval. Does anyone follow the company or have a different opinion on the company?

They have one product: Immunosyn Corporation has acquired from Argyll Biotechnologies, LLC the worldwide rights to market, sell and distribute SF-1019.

"SF-1019 is believed to be one of a new class of therapeutics made from mammalian cells. As an isolated compound, SF-1019 is comprised of low molecular weight lipo-peptides. Pre-clinical human studies and clinical trials in animals have shown SF-1019 to provide therapeutic benefits without toxic or pyrogenic (fever-causing) effects at therapeutically effective dosages. In animal studies, once injected subcutaneously, SF-1019 produces an immunomodulatory cascade, which generates a prophylactic and/or therapeutic benefit. In pre-clinical human studies, it appears to create a therapeutic affective response over a range of demyelinating conditions of the peripheral nervous system (PNS) resulting in rapid reduction of symptoms. A major benefit of SF-1019 is its perceived ability to simultaneously target, activate and support the modulation of both the innate and adaptive immune systems, having a dramatic effect on many neurological and demyelinating conditions. Research suggests the current product has additional developmental potential as it also possesses analgesic properties with an ability to substantially reduce the inflammation attending a number of clinical conditions including Multiple Sclerosis (MS), Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Reflex Sympathetic Dystrophy Syndrome, (RSD or RSDS) and other auto-immune and neurological disorders."

Low Testosterone Levels Increase Mortality Risk in Men

June 18, 2008 (San Francisco) — A population-based cohort study has demonstrated a link between low levels of testosterone and increased risk for mortality from all causes in adult men of all ages.

Robin Haring, a doctoral candidate with the Institute for Community Medicine and the Department of Internal Medicine at Ernst-Moritz-Arndt University in Greifswald, Germany, presented the results here at the ENDO 2008, the Endocrine Society 90th Annual Meeting.

"When we compared survival times of men with low testosterone levels to men with higher testosterone levels, we found that men with low testosterone had significantly lower survival," Mr. Haring told Medscape Diabetes & Endocrinology. "From our analysis, we concluded that men with testosterone levels lower than 8.7 nmol/L had a 2-fold increased risk of death."

Mr. Haring and colleagues at the university recruited 1954 men aged 20 to 89 years through the Study of Health in Pomerania initiative and followed the participants for an average of 7.2 years through August 2007. Participants were classified as having low (<8.7 nmol/L) or high (≥8.7 nmol/L) testosterone levels, and the researchers compared all-cause and cause-specific mortality between the 2 groups.

During the follow-up period, 226 deaths occurred in the study population. After adjusting for age and other risk factors, the researchers determined that participants with low testosterone had a significantly higher risk for all-cause mortality than their normal-testosterone counterparts (hazard ratio, 2.6; 95% confidence interval, 1.6 – 4.1; P < .001).

In a more specific analysis of causes of mortality, the researchers found that men with low testosterone levels were at increased risk for death from cancer and cardiovascular disease but not respiratory disease. The men in the low testosterone group tended to be older and had higher prevalence of diabetes, hypertension, and metabolic syndrome, and Mr. Haring acknowledged the challenge in determining whether low testosterone was a cause or effect of the cardiovascular risk factors.

Hugh Jones, MD, lead investigator of a study presented in a related session and a consultant physician and endocrinologist in the Barnsley Hospital Center for Diabetes & Endocrinology at the University of Sheffield, United Kingdom, said that the study by Mr. Haring and colleagues underscores the importance of treating men with low testosterone levels even in the absence of symptoms.

"A large proportion of younger men with obesity and low testosterone don't have symptoms," Dr. Jones explained. "What we're doing now is treating classical hypogonadism by definition according to the published international guidelines."

Mr. Haring and Dr. Jones have disclosed no relevant financial relationships.

ENDO 2008: The Endocrine Society 90th Annual Meeting: Abstract OR35-1. Presented June 17, 2008.

<<<<don't you think that the execution is improving?>>>

I still think its one of the most hyped stocks I've ever seen. Driscoll recent quote "we are well-positioned now to move from our pre-partnership phase into our global partnership stage". That statement is laughable. What he really means is that our first attempt to partner didn't work out so we're taking a different strategy.

Driscoll, "The competitive interest in these partnership activities has intensified over the last several weeks." Do I need to go on?

Do you remember the huge production they made concerning the Dyloject sales team? $66K for the qtr and they met their internal sales projections. They've given $75 million as projected EU Dyloject sales after a few yrs. Is that their internal numbers or what they give in presentations?

I've only got a small holding in JAV at this time. How can I have a big position if I don't trust the guys?

PS I asked the question a while ago - if Joe thinks that big pharma and he will agree on a price in the future, but can't agree on one now then the implication is that he and big pharma disagree on the risk between now and then. The interesting question is why. I think it is now obvious that the answer is probably mostly safety and the FDA's opinion about safety for a drug in this class.

We both know that Pharma is not going to pay more then 1x the market cap for a biotech or shareholders would throw them out if a clinical failure occurred. The max offer for RPRX at this stage is less then $300 million.

Joe thinks RPRX is worth a billion within 2yrs due to Proellex's efficacy, revenue potential, and lack of safety issues. If the only question as far as Joe is concerned is the time value of money then $300 million would be inadequate.

Joe runs the risk that it will take longer then expected to complete the trials or a safety issue develops and pharma runs the opportunity risk of another company buying RPRX.

Pharma would rather pay more and take on less risk whereas Joe thinks the risk of failure is small so why accept a severely discounted offer.

Its true that safety plays a large part in trying to determine a buy-out price, but I don't see how pharma could make an acceptable offer considering RPRX's current value.

If I've got this right, Exwannabe & iwfal follow the stock since they think its got potential, but are waiting for a better buy-in opportunity. They both agree to the following:

"The issue is timeline vs. cash.

I may very well be wrong by being out right now, that's life. But I still think it is more likely that I will get to buy back in later (3-6 months) at a discount. "

My question is do you use the market cap & clinical progress in comparison to other companies when making your prediction or is your prediction based on the cash balance or stock price?

What is more important?

"I'll give you 1:2 (I'm the one, your the two) that before Proellex is approved next year it will at the least have had to add another 1 year of clinical trials (human or animal) before it can get approved."

Whats really frustrating is that you seem to think we would be surprised if the FDA asked for additional long term data. It would be a shock if the FDA didn't considering the current regulatory environment & the questions surrounding Asoprisnil. Its far easier for the FDA to ask for additional data then it is to approve a new drug class.

Upcoming events?

"We have the full biopsy dataset by the end of July? And the two p3 anemia trials by late August/September? What else is coming up? It'd be nice if this information was in the IBox or on the company website. It might be in past presentations, but I'm not sure. Any other big derisking events coming up in the next few months?"

Two-year rat carcinogenicity study of Proellex results of gross findings are expected in July.

How perceptive are you? Quick 1 minute video.

http://transformationteam.net/video/perceptual_experiment_tc

I didn't realize my reference was actually FDA guidance on Carcinogenicity Studies with Rodents for the testing of food ingredients. I'm amazed how closely it follows the drug carcinogenicity recommendations.

It looks like the 2 yr rat carcinogenicity results in July will complete the requirements for Proellex.

I'm not sure different species means one rat and one mouse.

"It is important to consider the test animals' general sensitivity and the responsiveness of particular organs and tissues of test animals to toxic chemicals when selecting rodent species, strains, and substrains for toxicity studies. The selection of inbred, out-bred, or hybrid rodent strains for toxicity tests should be based upon the scientific questions to be answered. Additionally, it is important that test animals come from well-characterized and healthy colonies. Because recent information suggests survivability problems exist for some strains of rats, test animals should be selected that are likely to survive for the recommended duration of the study"

http://www.cfsan.fda.gov/~redbook/red-ivc6.html#ftnII

Repros Therapeutics Inc. Announces That Initial Findings for Proellex(R) Show No Gross Cancer Tumors in First Completed Animal Carcinogenicity Study
Monday June 9, 6:00 am ET

THE WOODLANDS, Texas--(BUSINESS WIRE)--Repros Therapeutics Inc. (NasdaqGM:RPRX) today released initial findings from evaluation of gross necropsies conducted upon completion of the in-life portion of a six-month mouse study conducted to satisfy a portion of the FDA mandated two-species trials to demonstrate the lack of carcinogenic potential for new chemical entities. In the positive and negative controlled study, Proellex showed no gross potential for tumor induction as compared to both controls. Proellex was tested at 10, 40 and 100 times the human dose in this well-recognized and characterized study. As expected the positive control, urethane, yielded easily identifiable tumors on gross necropsy. In a previously completed battery of studies, Proellex showed no genotoxic activity, an early indicator of potential for induction of cancerous tumors.

A mouse carcinogenicity study of Proellex was sponsored by Repros Therapeutics at BioReliance in Rockville, Maryland using a breed of mice bearing the rasH2 mutation. These rasH2 mice have been genetically manipulated making them primed for the development of tumors when treated with carcinogens. Male and female animals have been treated with multiple doses of Proellex for 26 weeks and an evaluation is being made as to whether cancers have developed over that period of time when compared to a control material. A gross examination revealed no apparent indication of a tumorigenic response. All tissues are currently undergoing microscopic evaluation. A final determination of carcinogenic potential is pending.

A two-year rat carcinogenicity study of Proellex is also nearing an end and results of gross findings are expected in July.

Joseph S. Podolski commented, “We continue to be pleased with the excellent progress being made in our NDA program for Proellex. We will provide timely updates to our shareholders as additional data becomes available.”

About Repros Therapeutics Inc.

Repros Therapeutics focuses on the development of oral small molecule drugs for major unmet medical needs that treat male and female reproductive disorders.

Our lead drug, Proellex®, is a selective blocker of the progesterone receptor and is being developed for the treatment of symptoms associated with uterine fibroids and endometriosis. We are also developing Proellex as a short course pre-surgical treatment for anemia associated with excessive menstrual bleeding related to uterine fibroids. There is no currently-approved effective long-term orally administered drug treatment for uterine fibroids or endometriosis. In the United States alone, 300,000 women per year undergo a hysterectomy as a result of severe uterine fibroids.

Our second product candidate, Androxal®, is a single isomer of clomiphene citrate and is an orally active proprietary small molecule compound. We are developing Androxal for men with low testosterone and adult-onset idiopathic hypogonadotrophic hypogonadism (“AIHH”) with concomitant plasma glucose and lipid elevations, all of which are components of Metabolic Syndrome. We are also developing Androxal for men of reproductive age with low testosterone levels who want to improve or maintain their fertility and/or sperm function while being treated for low testosterone.

Question for the board here...

<<<Do you feel the biopsy results of the 29 women that will
be released in Aug/Sept are an important derisking event?..>>>

Yes

<<<<Do you think positive results will be a catalyst for the
share price?>>>

No


If the biopsy results for the 6 women didn't move the stock price then I doubt 23 more will. Fibroids & Endometrosis are not as exciting as Hepatitis, heparin, or Multiple sclerosis. We need some positive analyst comments & some institutional buying.

"The company has responded to my e mail and stated that there are now 2 clinical sites open and the first patient will be treated imminently.JAV will put out a press release at that time--which means any day."

We've seen them use the "imminent" time frame before and it ended up taking months. Do you remember Carr stating that Dyloject's UK approval was "imminent". Driscoll made the start of the trial one of his main objectives for the year and he's failing miserably. If he used the term imminent then it should have occurred this week.

Do you realize that everything gets pushed back? The German approval for Dyloject was supposed to take place in the 2nd qtr and now their anticipating the 2nd half of 2008.

I've never seen a company not be able to meet any deadlines.

Y3maxx, all we need are a few more of those 1000K share buys and RPRX will be rocking. Just kidding, I did see a 15K share buy at $10.70 which is pretty good considering this market.

Volume and size of trades keeps looking better. We've gone from 100 share trading to 1000K share trades.

I'll stick to my comment. Sometimes there's some truth in a rumor.

Looks like we've got someone whose decided to take a position. Hope their a large buyer. Rumor is that Androxal is getting some attention.

Just think how this stock would move if we got some positive press and some volume. Up $1.16 Weeeeeeeeeeeeeeeeee

I don't even see the trial listed on the Clinicaltrials.gov website.

How can you say my ISIS post was FUD? I'm the only investor who posts on the ISIS board & I gave up since no one was interested in the company. The FDA changed the requirements for MIPO's approval whereas the FUD on this board is that the FDA "may" change the requirements, or the requirements "may" be a higher standard.

RPRX receives an unusual amount of criticism for a company in which the CEO has been extremely honest, conservative cash burn, the company meets every clinical deadline for the most part, the clinical trials have been overwhelmingly positive, and no safety issues have arisen.

I own shares of ISIS & RPRX. The question is how many of the posters who challenge every PR, clinical trial design, etc. have shares of RPRX?

I realize as much as anyone that Proellex has a long way to go before gaining FDA approval, but RPRX is doing a good job of moving forward and the risks are no different then with any other small biotech. This board has been dominated by negative posters to such a large degree that a number of the well informed investors don't bother to post.

The same FUD seems to dominate the board. I don't understand why this stock seems to attract an unusual amount of attacks.

If anyone thinks I'm exaggerating just remember the FUD we had to deal with surrounding the anemia NDA.

When you say he wanted to discuss the current status at the conference are you referring to the break-out sessions?

I think the company was excited about the results and decided to release them before Mutter performed his independent blinded data review. JP had already stated that he felt this was the biggest risk in the near term and it looks like we've passed with flying colors.

Today's CC. Did anyone else get the impression that JP was trying to get through the presentation as quickly as possible. He may need to dumb it down a little for the audience to get an understanding of Proellex & Androxal.

Most long time holders have all the shares they intend to buy. There is a poster on the Yahoo board (see below) who states he shorts the top of the range & buys the bottom so I think alot of small day traders are doing the same.

"Nice little equity to day trade.........
pain in the ass to get filled , but buying
in the 9.20s and selling at 9.70 and then shorting and then buying and then........
wouldn't be surprised to see 9.60- 9.65
today ."

Todays PR is not going to attract any new investors unless their willing to do some research. The analyst day in July is our best bet to attract some new individual investors and funds.

They had previously announced that the N would be 29. I'm sure they will give the number of actual biopsies after the 2nd review. They are not hiding anything, this is just a preliminary finding.

If there had been an abnormal finding then they probably would have waited to release the results until their expert had done his evaluation.

Todays press release states "To date there have been no findings of abnormal endometrial biopsies post menses after cessation of administration of drug. "

Sounds pretty good to me. RPRX has a leading expert who does a second blinded review of the biopsies and they will release a PR after he has done so.

This was the big risk event that Joe referred to in the last conference call. The results were supposed to be released in July. This is a big event, but the market will probably yawn as usual.

The Interim Endo study (the 75 patient study) results should be by end of June.

CC is about to start. Joe may have some interesting comments.

Repros Therapeutics Inc. Announces That Initial Findings for Proellex(R) Show No Adverse Effects on the Endometrium after One Year on Drug
Thursday May 29, 6:00 am ET

THE WOODLANDS, Texas--(BUSINESS WIRE)--Repros Therapeutics Inc. (NasdaqGM:RPRX) today released encouraging results from its one-year extension safety study of Proellex in the chronic treatment of the symptoms associated with uterine fibroids. To date there have been no findings of abnormal endometrial biopsies post menses after cessation of administration of drug.

ADVERTISEMENT
Repros has described in previous communications that it had developed a unique approach to dosing with Proellex which treats women for four months (16 weeks) and then stops treatment to create an “off drug interval” until the next menstrual period commences and then recommences treatment for four months. These cyclical treatments are designed to be used for chronic treatment of symptomatic uterine fibroids. The rationale for this treatment regimen is that most of the reported bleeding events in previous studies occurred after 16 weeks of continuous treatment and were accompanied by endometrial thickening. By allowing a menstrual flow to occur after treatment withdrawal, the endometrium would be refreshed and the tendency toward a progressive endometrial thickening would be eliminated.

Joseph S. Podolski commented, “These early findings further convince us of the utility and safety of Proellex in the treatment of significant female disorders. These are early findings. However, the consistency of endometrial effects both while on drug and following menses post prolonged exposure support our “off drug interval” approach going forward. We look to share our observations with our shareholders and the scientific community as more data becomes available.”

About Repros Therapeutics Inc.

Repros Therapeutics focuses on the development of oral small molecule drugs for major unmet medical needs that treat male and female reproductive disorders.

Our lead drug, Proellex®, is a selective blocker of the progesterone receptor and is being developed for the treatment of symptoms associated with uterine fibroids and endometriosis. We are also developing Proellex as a short course pre-surgical treatment for anemia associated with excessive menstrual bleeding related to uterine fibroids. There is no currently approved effective long-term orally administered drug treatment for uterine fibroids or endometriosis. In the United States alone, 300,000 women per year undergo a hysterectomy as a result of severe uterine fibroids.

Our second product candidate, Androxal®, is a single isomer of clomiphene citrate and is an orally active proprietary small molecule compound. We are developing Androxal for men with low testosterone and adult-onset idiopathic hypogonadotrophic hypogonadism (“AIHH”) with concomitant plasma glucose and lipid elevations, all of which are components of Metabolic Syndrome. We are also developing Androxal for men of reproductive age with low testosterone levels who want to improve or maintain their fertility and/or sperm function while being treated for low testosterone.

Whats happened to this board? Did everyone leave and forget to tell me? Maybe tomorrow's conference will draw out some lurkers.

Repros Presentation to Be Webcast from the FBR Capital Markets' 12th Annual Spring Investor Conference

THE WOODLANDS, Texas--(BUSINESS WIRE)--Repros Therapeutics Inc. (NasdaqGM:RPRX - News) announced today that the Company’s President and CEO, Joseph Podolski, will present a corporate overview on Thursday, May 29, 2008, at 9:00 a.m. Eastern Time at the FBR Capital Markets’ 12th Annual Spring Investor Conference.

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To access the live presentation, log onto Repros’ website at http://www.reprosrx.com and click on the FBR Conference Heading under Events on the Repros Home Page. This link will take you to the registration page of the conference. Please connect to the website prior to the start of the webcast to ensure adequate time to download any software that may be necessary. The webcast recording will be archived and available on the Repros website for 30 days following the presentation.

The March/20 8-k pertained to Proellex. This could be the first step to signing a foreign partner.


"On March 15, 2007, Repros Therapeutics Inc., a Delaware corporation (the “Company”), entered into the Fifth Amendment (the “Fifth Amendment”) to the Agreement by and between the National Institutes of Health or the Food and Drug Administration (collectively, the Public Health Service or PHS), agencies of the United States Public Health Service within the Department of Health and Human Services and the Company (as amended, the “Agreement”). The Fifth Amendment amended the benchmarks that the Company is required to meet under the Agreement. On March 8, 2007, in connection with the Fifth Amendment, PHS granted to the Company a waiver of the requirement under the Agreement that the Company have Proellex manufactured in the United States. For clarity, the Company is also filing the Fourth Amendment to the Agreement (the “Fourth Amendment”) dated December 9, 2003 which was an amendment relating to the purchase from the PHS of an immaterial amount of Proellex for use in the Company’s clinical trials at such time. The Fourth Amendment did not change any other provisions of the Agreement."