Was already rotating out of Feb Calls & Puts as a precautionary move and will be doing same with Mays and Junes. If the results on the loc. ca. are acceptable, no prob.; if they're not good, Puts will protect me some. Worst thing -- what we've had now for 13 yrs. -- are delays born of ignorance and inexperience. Running a public company is not for rank amateurs. The co. is now at a critical juncture; the proper, ethical thing to do is bring in competent management.
Sold all my stock (avg cost $3.21-4.50). Still holding options. Would have sold options except position just too large to unwind. Haven't lost faith in the drug and don't believe this is a scam. Problem here, as I've said all along, is amateurish management, never so clear as Jan., when wo/ explanation co. abruptly reversed course to deal with foreseeable complication. Have old fashioned views -- born of experience -- on the importance of consistency. Best of luck to you, Fenix and all the other longs . . . looks like I'll be with you to the end.
Can't speak for the FDA. My point had to do with the bet-it-all-on-one-dataset aspect of this approach. Speaking only for myself, and without regard to whether or not the data is like Ph. II, I would want to get it out it ASAP. And let me add this: I've never questioned the honesty of the co. or its mngmt. What I question is the failure to keep the market informed -- in my view, the primary responsibility of a public co.
See my comments above. Obviously you have to decide for yourself whether it is the last straw . . . it is, clearly, a 100% change of plan which, it this were a normal company, would be accompanied by an explanation. Instead, we are merely given the decision -- an approach which almost guarantees, given the co.'s prior behavior, unfavorable speculation and frustration.
You and your prof investor friend were dead right. Sitting on market-moving information is still a no-no however, so an "approval from FDA" to withhold in hand data would seem to be the least that would be required to avoid problems with the SEC and lawyers trolling for claimants. A less friendly view of the situation might be that the company is already in possession of negative info, which it hopes to offset, ameliorate or bury by releasing it as a package. Looking on the bright side-and making allowances for the CEO's anal thinking--there may be a belief that the entire data set will be needed to extract the best deal from Big Pharma. Who knows? What I do know is that I am tired of this bubble-head and his childish naivete about what is required of a public company, his secretiveness about the NX 1207 and his efforts to control the behavior of the market with the selective release of information. One this is sure. By electing to hold out until the end of the second quarter 2014 (or later) he has certainly ratcheted up the pressure on himself and on his company.
Company appears to be in lock down mode, suggesting that the release of news MAY be imminent. Your guess as to the nature of that news is as good as mine, though I would point out that sitting on market moving news -- specifically topline results of Ph.III -- would be a legal no-no.
You thinking "Quiet Period?" If so, we could have answer very soon.
Fair point. But note the same silence re: the competing Sophiris product, now in Ph III. Except for a complaint from a trial participant diagnosed with pros. ca. -- apparently pre-existing -- the message boards and blogs are very quiet. Another way to view this: patients are either happy with their outcome, not inclined to complain about minimal benefit and/or going back for more. BPH is not (normally) life-threatening, so may not inspire blogs and msgs. Who knows? If you're really worried you might try calling Inv. Rel.
Clearly, you're not the only one who is beginning to think that way. The question -- for everyone -- is what are you going to do about it. Bail out on the eve of the ph. III results, or hang around until the results are in? I think I've made my own position clear: I am holding a large amt. of well-hedged NYMX stock and options. If the drug prove to be as advertised, my investment should increase in value by a factor of 10-20; if it does not, I will cash in my puts and move on to the next one This is a classic asymmetric investment, made more problematical by the lack of inst. involvement. It forces investors to confront their belief system and their inv. philosophy. Do you like the product? Can you trust Doc A to do what is in his best interest? The rest, the delay in getting the drug through trials (partly due to FDA meddling), the Doc's deficits, are either deal killers or background noise, you will decide.
Reading between the lines of the study protocols, the co.'s press releases and Dr. A's ex cathedra remarks, it would appear that 1.) the BPH study and the localized prostate cancer study were designed to produce actionable information at roughly the same time, viz during the first quarter of 2014; 2.) the results of the two studies are to be presented to potential acquirers as a "package" to maximize leverage and increase the value of a deal ("two drugs for the price of one"); 3.) months of positive reports re drug safety leave no legal room for last minute surprises; 4.) symptom scores, being by nature subjective and dependent on the doc's aim, etc., may very well vary, but not enough to give the edge to any of the alternative remedies on offer. In short, the drug is teed up for FDA approval, will likely be approved in due course and become an instant hit with patients and a profit center for urologists who have been looking for something to do with their hands since the decline of PSA test driven prostatectomies. So what can go wrong? As always with this company it will come down to management. If Dr. A. wants too much or is too invested emotionally he'll scare away acquirers, who -- all things being equal -- might like his help in mktg to docs, but who'll run from the room if he starts talking about HIS drug, HIS need to save men from the scourge of BPH, etc. If it were me, I'd want a clean deal, a buyout not a royalty arrangement like Ricordati,, with Dr. Averback. completely out of the picture. One last point: He needs to get on with it -- if he's not already involved in serious talks with an acquirer (because the results are still being tabulated), he should move to do so as soon as possible. The evident lack of institutional interest in this company suggests that he lacks credibility, perhaps as a result of too much loose talk about not rolling over for Bit Pharma. Either way, he needs to price the company to sell and do a deal, now.
Sorry, can't stand Facebook. Best wishes to all the old longs who've taken refuge there from the gang-bangers who dominate this board.
Still here. The topline ph. II results did not really surprise me (see my previous posts on this board), given the need for time and subgroup analysis to reveal the therapeutic value of these agents. In fact, the results here mirror or at least parallel the interim results for all similar drugs. The game is not over -- or if it is, the startling results for IMUC's phase I , as well as the equally encouraging results on NWBO, GALE, CLDX, BMY, MRK, etc were all "cooked." If you don't grasp the science, believe people are crooks or (like the shorts) have an agenda, you bail out at the first sign of trouble. I've read ALL of the studies, don't think Yu, et all are crooks (though Ph. II WAS badly designed) and believe IMUC will right the ship. Keep this in mind: these drugs are designed to help the immune system recognize CA, whereas the anti-inhibitor drugs (cf. BMY, MRK), are meant to unleash the immune system. In my view, it will take a combination of the two approaches to actually cure cancer -- this assuming the genetic characteristics of the tumor cells are known and properly targeted.
at the Broad Institute when the study was conducted.
The study identified 13 mutations that occurred frequently enough across the samples to be considered significant in cervical cancer. Eight of these mutations had not been linked to the disease previously, and two had not previously been seen in any cancer type."
"Another key finding was the prevalence of mutations in genes affecting the immune system. Mutations in the gene HLA-A, which helps the body distinguish its own proteins from foreign invaders, were previously found to drive squamous cell lung cancer. In this study, another gene in the same complex – HLA-B – was found to be commonly mutated in cervicervical squamous cell carcinoma. This suggests that disruptions to the immune system may play a bigger role in cancer progression than was previously realized.
Finally, transcriptome sequencing, which allowed the team to analyze gene expression – how and when genes are activated across the genome – enabled the researchers to learn more about how HPV is driving cervical cancer.
It has long been known that exposure to HPV is a primary risk factor for cervical cancer. Once an individual is exposed, the immune system often clears out the infection, but in cases in which the virus lingers, it can integrate itself into the human genome. This study looked at where, in the genome, HPV inserted itself and found that HPV integration sites were associated with higher levels of gene expression and were often amplified, resulting in many copies of those sections of the genome. This connection between HPV integration and gene expression suggests that the virus may be driving cancer by promoting and elevating the activity of mutated genes.
"Our findings further elucidate the key role HPV is playing in the development of cervical cancer, which in turn emphasizes the importance of combating the disease by vaccinating against HPV," Meyerson said . . . ."
Continuing . . . "from 115 cervical cancer patients from Norway and Mexico. In some cases, the researchers also conducted whole genome sequencing (analyzing the genetic code across the entire genome) or transcriptome sequencing (focusing on gene expression). In each case, the researchers compared genomic data derived from cervical cancer tumors with genomic data from healthy tissue from the same individual to determine what may have gone wrong – or mutated – in the genome to allow the cancer to develop. The mutations identified in tumors but not in healthy tissues from the same individuals are referred to as somatic mutations.
The study benefited from the international collaboration of scientists from research institutes across the globe and was made possible by SIGMA – the Slim Initiative for Genomic Medicine in the Americas – which promotes the study of genomic medicine in the service of global health.
"Low and middle-income countries suffer the largest burden of cancer in the world," said co-author Jorge Melendez, of the National Institute of Genomic Medicine in Mexico City. "Nevertheless, only 5 percent of all the global resources dedicated to this group of diseases are allocated to them. Initiatives that promote joint efforts with developing countries will help to advance not only the knowledge of the shared and distinct biological aspects of cancer diseases, but also highlight local action items to impact public health."
The cooperation of teams from the U.S., Mexico, and Norway was essential in order to sequence samples from a diverse pool of cervical cancer patients.
"Without this sort of international collaboration, the genomic view of a disease can be limited. By analyzing genomic data from diverse populations, we can discover patterns to disease progression in context of the full range of human genetic variation," said co-senior author Helga Salvesen. Salvesen, a professor of clinical medicine at University of Bergen, Norway, was a visiting scientist
From Broad Institute PR: "International team completes systematic, genomic study of cervical cancer
Findings point to potential therapeutics, shed light on HPV role
Researchers from the Boston area, Mexico, and Norway have completed a comprehensive genomic analysis of cervical cancer in two patient populations. The study identified recurrent genetic mutations not previously found in cervical cancer, including at least one for which targeted treatments have been approved for other forms of cancer. The findings also shed light on the role human papillomavirus (HPV) plays in the development of cervical cancer.
The study, which appears online in Nature, addresses a public health concern of global significance: cervical cancer is the second most common cancer in women and is responsible for approximately 10 percent of cancer deaths in women – particularly in developing countries where screening methods are not readily accessible. Almost all cases of the disease are caused by exposure to HPV and it is expected that vaccination efforts targeting HPV will decrease cervical cancer cases over time. In the meantime, however, the disease remains a significant threat to women's health.
"Cancer is a disease that affects the whole world, and one question that always arises is: is a given cancer type similar or different across populations?" explained Matthew Meyerson, one of the paper's co-senior authors. Meyerson is a professor of pathology and medical oncology at Dana-Farber Cancer Institute and a senior associate member of the Broad Institute. "While we don't have the complete answer yet in this case, what we are seeing is that, in two different populations, the causes of cervical cancer are similar and, fundamentally in both cases, it comes down to HPV-genome interaction."
To investigate the genomic underpinnings of the disease, the team performed whole exome sequencing, which examines the genetic code in the protein-coding regions of the genome, on samples from 115. . .
Exactly right. The sooner mgmt gets this info to investors, the better. If the 57 survivors are mostly from the treatment arm, and its hard to believe there wasn't some survival advantage (unless Ph. I was "cooked," which I view as unlikely), that should show up in the numbers. If the survivors in the SOC arm were randomized later than the survivors in the treatment arm - also hard to believe -- that might explain why there is no clear survival advantage. Though I was fully hedged against the possibility of bad news, I have a large position here. I am losing patience with a mgmt that doesn't know when to be silent and when to speak up.
The current mkt. cap for this stock is a little over 50 million. Cash on hand is 30 million. No debt. Meanwhile, Ph. II, described everywhere as a disaster actually met an imp. secondary endpoint and was merely inconclusive as to OS -- this with a fair prospect of a long "tail" like Yervoy, etc. Meanwhile, shorts -- bless their black hearts -- continue to drive down the pps, which, with their help, may soon reach 80 cents a share or even less. I leave the rest to your imagination which, if some posts on this board are any guide are working overtime . . . .