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Some good dd is available here
https://imetelstat.eu/
Trend try reading some of the releases of the science, the presentations.
Either buy in or don't, your choice, but do your own dd.
A mb is not the place to do research.
You have stumbled on something quite amazing.
It will be up to you to earnestly and humbly research it or you can flail and grandstand on mb's stating this and that...
But you better decide quickly as you are late to this.
In my opinion martin, it already is.
The same science they use to cut a cancer cells lifespan, they could then turn around and use to increase the life span...
potential of the fountain of youth as well as cancer cure that could be had here...for $4/share...unreal.
They just got Orphan Drug Status in the EU, and there are a ton of shorts...
CEO LATE BREAKING NEWS WEBCAST 11-18-15
Late breaking news approved Europe Orphan Drug about 4 to 5 mins in webcast. Tells me you would not have read this for download pdf version because when made up they didn't know. They will have to post this in the next couple days. Long Term Great News.
Hi TRUTH,
I guess it depends on one's perspective.
My responses are based on my bias as a Long.
If the science works out and can be capitalized on, then it will not be how much you paid to acquire the shares of a dollar or two difference...
...but will be how many shares you held onto and have.
In my truly bias opinion,
Cheers,
TRUTH
Don't look as a trader, but as an investor
Cheers,
Here we are on a day the market is down, including stem's...
Asterias Biotherapeutics, Inc. (AST) -NYSE MKT
4.11 Down 0.50(10.76%) 2:37PM EDT
Volume: 380,201
Avg Vol (3m): 299,086
BioTime, Inc. (BTX) -NYSE MKT
3.61 Down 0.02(0.55%) 2:39PM EDT
Volume: 177,061
Avg Vol (3m): 394,392
Neuralstem, Inc. (CUR) -NYSE MKT
1.91 Down 0.04(1.80%) 2:42PM
Volume: 215,189
Avg Vol (3m): 766,113
Pluristem Therapeutics, Inc. (PSTI) -NasdaqCM
2.51 Down 0.01(0.40%) 2:39PM
Volume: 169,631
Avg Vol (3m): 158,357
Geron Corporation (GERN) -NasdaqGS
4.33 Up 0.05(1.17%) 2:43PM
Volume: 6,145,377
Avg Vol (3m): 2,365,640
And yet, Geron is positive...
LOOK AT THE VOLUME COMPARED TO AVG VOLUME - That is where the truth is, in my opinion...
Shorts covering, accumulation going on.
Buy/Hold
Hold Long Term, and you will be very happy you did...
Well that is interesting,
The only near negative words in the whole report is that Geron is depending on Imetelstat...
reall..? No sheet sherlock...
But yet the write about how other analysts are upgrading the stock and target PPS, how successful the PPS has been of late, and how earnings were better than expected and up over 14%
And yet, they change their call to Hold from Buy
and with only about 30 million shorts, roughly.
I'm not a conspiracy theorist, but I smell a rat here,
Or they're mis-calling that due to caution...
just seems strange when you read the actual report, compared to the downgrade,
If this is true, it could be the start of something...
from yahoo,
In the MIT Technology Journal Geron's solutions are mentioned several times as "cures". This is not a frivolous journal. This is the July/August issue which just arrived and I have not read (only glimpsed) these articles.
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It is actually listed as the MIT Technology Review. Google this and the website will popup. However, they have yet to add the latest issue to the website. MIT refers to the university/college. It is an excellent and cheap ($12.00 per year, if my mind recalls correctly). I consider this to be a "must read" for myself. It does not refer to Geron per se; but the technologies are definitely Geron's proprietary patents. It also covers all areas of "study".
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Nice
Trial of JAK Inhibitor Fedratinib For Blood Cancer Discontinued
This is a quote from Dr. Tefferi's mouth today. Read the last sentance carefully.
Dr. Tefferi: "The value and limitations of JAK inhibitors in myeloproliferative neoplasms are now clear; they are capable of alleviating symptoms and reducing spleen size in about a third of patients but this activity is not durable (average duration of response is one to two years) and the drugs have not shown convincing evidence of disease-modifying activity. It is unlikely that additional JAK inhibitors (e.g. momelotinib) are going to do any better in the latter regard but might provide a better toxicity profile in some (e.g. anemia) but not in other (e.g. peripheral neuropathy) regard. There continues to be unmet need for patients with myelofibrosis and other myeloproliferative neoplasms in terms of disease-modifying drugs and patients might be best served by participating in clinical trials with drugs that might be capable of achieving this important goal."
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We have to remember that Dr. Tefferi was once working with the Jak Inhibitors and left that program because of it's limitations..Now the good Doctor is working with Imetelstat and once said something to the effect that,if he had Myelofibrosis,he would want Imetelstat..Who would know better than THE Doctor that was involved with both drugs first hand?
So,who should we listen to? Some of the naysayers that infest this message board or Dr Tefferi? Geron/J&J get closer to their goal of approval for Imetelstat with each passing day..Let the professionals do their work
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Full story at;
http://medicalresearch.com/cancer-_-oncology/trial-of-jak-inhibitor-fedratinib-for-blood-cancer-discontinued/15131/
Oh absolutely stock...
These daily fluctuations are nothing more than trying to pry shares loose, with either Greed or Fear...
Shorts are covering, except for hedging.
Funds and institutions and insiders are buying...
Traders will be traders...
Follow Imetelstat On Facebook
You won't have to deal with short holder's desperation there. Who is sorry they shorted Geron now? To quote a fellow long Geron holder, HA HA HA HA HA HA HA HA HA HA HA HA!
https://www.facebook.com/imetelstat?fref=nf
Unbelievable source of information and detail of the science...
from yahoo...Imetelstat summary
Imetelstat summary 1
Don't listen to the fearmongers. This late in the game, after so much proof positive data supports Imetelstat's efficacy, fearmongers will say anything to further their position. Here's a brief overview for any new comers.
Cancer treatment is at a crossroads. The traditional way of resection followed by powerful (and toxic) chemo agents is being revolutionized. One of the main arms of research is immunotherapy(IT), which is training the host's cells to identify cancer cells and destroy them. Those cancer cells are identified by antigen markers on the cell surface. Some ITs target a few antigens, some target a few more, but right now I'm not aware of a single IT agent that comes close to curative. The fact that neither many-antigen nor fewer-antigen IT agents have an immediate or drastic effect on the disease says something fundamental about the model. That is to say, IT's approach is like an infantry assault on the front line of another infantry. Infantry is important, but it's not what drives an army, it's the command and control and resources, which you can equate to cancer stem cells, or even further upstream to the very genomic aberration that started it all. So I don't personally believe IT will be a curative approach. I do think it will play a part and it will mature, and there are benefits. IT is extremely safe b/c it's cultured from the host's own cells; but that's a drawback as well, b/c each treatment is individually tailored, so you're talking about an expensive process.
The other approach is small molecule drugs, which isn't anything new as a model. Some chemo agents are small molecule drugs. But the difference is that chemo effects cytotoxicity, basically poisoning the cancer (and the host) with varying degrees of selectivity; whereas the newer generation of these small molecule drugs target cancer's systematic processes selectively and creatively. Imetelstat is one of the latter.
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Imetelstat summary 2
So let's make the comparison between Ruxolitinib and Imetelstat. Ruxolitinib inhibits an enzyme called Janus Kinase(JAK). JAK plays an important role in a signaling pathway called the JAK-STAT pathway which, for people with deletarious types of JAK, ultimately contributes to dysregulation of gene expression, and disease. But JAK-STAT dysreguation isn't the disease itself, its signaling pathway is an artifact of the pathogenesis of the disease, NOT the cause, and NOT a critical pathway, either. So it follows that the efficacy of JAK inhibitors would be poor, and that's exactly what we see. In the best case scenario, Ruxolitinib reduces splenomagaly and eases constitutional symptoms of MF. And even that modicum of benefit is compromised by serious side effects, as the JAK-STAT pathway also regulates the immune system, also liver toxicity. A study by Dr. Tefferi demonstrates a 50% discontinuation of Ruxolitinib by the 2nd year, and 89% discontinuation by the 3rd, due to disease progression or toxicity. There isn't a scientist in the world that thinks JAK inhibitors cure, or will EVER cure MF. Simply put, dysregulation of the JAK-STAT pathway isn't the cause of the disease, nor is it a critical process to pathogenesis. So why target the JAK-STAT pathway? B/c it's one of the pathways we understand, it's low-hanging fruit. And the JAK inhibitor market is about to get fairly crowded, as several companies are developing their own.
A note about how these drugs are discovered. Often times someone will have a hypothesis for what will be an effective drug. Then they'll make a dozen versions of that drug, fairly arbitrarily, rearranging groups of molecules, adding or subtracting things, and then they'll test these dozen drugs and see which one works; then they repeat the cycle, creating dozens of further variants of the ones that work. It's a shotgun approach. And to date, we have Ruxolitinib. Which isn't to say it's worthless, but this is how science progresses... slowly.
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Imetelstat summary 3
Then Imetelstat comes along. Imetelstat is a telomerase inhibitor. This is a categorical shift from JAK inhibition b/c telomerase IS A CRITICAL ENZYME. As a comparison, JAK inhibition is like stopping a bank robber's car by shooting at the tires, and the tires are run-flats; telomerase inhibition is like shooting out the fuel pump and depriving the car of fuel and power, in which case the car will eventually slow to a halt. It is a supremely selective target, one with potential far and away beyond JAK inhibition, as 90% of cancers require telomerase. Unlike JAK, telomerase isn't a part of a complex signaling pathway; instead, it's one of the actual cellular machinery that directly makes DNA. And this is why Imetelstat is so powerful, its target is far far upstream to the JAK-STAT pathway and immunotherapy. Telomerase is a reverse transcriptase; instead of making DNA from DNA copies, it makes DNA from an RNA copy. That RNA copy is embedded in the enzyme, and that's the active site that Imetelstat targets. And the results have been revolutionary. In a disease where the only approach has been symptom management, Imetelstat ENTIRELY cleared high-risk MF patients of fibrosis AND EVEN the molecular signatures of the disease... THIS IS A VIRTUAL CURE for those patients, their actual disease state has been changed, not just symptom relief. For the ones that achieved CR, they live like they don't even have the disease. And for the ones that don't achieve CR, many still receive symptom relief. And this is also how science works, long periods of slow progress, jolted by sudden and drastic progress. Imetelstat is a revolution in treatment for hematologic malignancies; it ACTUALLY MODIFIES THE DISEASE.
Stem cell transplantation has also cured people, not virtually, but truly cured people. The few who qualify and respond positively to SCT are very lucky. But there are a host of complications with SCT, and it will never be a ubiquitous solution.
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Imetelstat summary 4
Imetelstat has a serious toxicity profile, which is the same as saying Ruxolitinib has a serious toxicity profile, which you can say for all chemo agents too. Getting in a car or an airplane can be deadly too. These are all potentially deadly things when not managed. And yet global transportation is a trillion dollar business, from cars, to planes, tourism, hotels, restaurants, all served by these dangerous, deadly machines. But let's make the comparison between Ruxolitinib and Imetelstat again... both have serious toxicity, but only Imetelstat virtually cures. And the Mayo clinic, Geron, the FDA, and JNJ all agree that Imetelstat's toxicity is completely manageable. The FDA placed a hold b/c they were concerned, and not only did they lift the hold, they also gave the green light for further studies.
The fear mongers pointing at Imetelstat's supposed liver toxicity are MASSIVE IDIOTS, since Ruxolitinib also causes the same liver problems, AND YET WAS APPROVED. These supposed liver toxicities are really just elevated liver enzyme activity, NOT TOXICITY, and these elevated activities resolve to baseline upon discontinuation, which is not to say patients with elevated liver activity can't stay on the drug. They can stay on it. Elevated liver activity in conjunction with other signals would indicate a problem; but in and of themselves, elevated liver activity is a small, small price to pay for someone who has a 1-3 year life expectancy.
Yes, Imetelstat has a toxicity that must be managed. But it has been managed and managed well for nearly 500 patients, WITH THE BENEFIT OF SOME MF PATIENTS BEING VIRTUALLY CURED. Something so simple as dose schedule modification has completely contained any serious toxicity. But how far the dose can be attenuated and still present efficacy is a part of this next study. This is getting really long so I'll try to wrap it up in the next one.
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Imetelstat summary 5 conclusion
The focus has been on Imetelstat as a single agent. But that's not the future. There were a few combo studies for solid tumors that haven't shown results, so from what little info they've released I assume they were lackluster. For MF (and probably MDS), Imetelstat as a single agent causes significant disease modification. This ALREADY is grounds for approval as a single agent, for the serious unmet need in MF and MDS, and probably as a combo treatment for AML.
But solid tumors are the real prize. We know Imetelstat works in hematologic malignancies, so the model for efficacy is there. But getting it to work in solid tumors will be the ultimate goal. Now having this model of efficacy from blood disorders is a major piece of the puzzle for unlocking efficacy in solid tumors. Those previous solid tumor combo studies were conducted years before Dr. Tefferi's unprecedented results. And now ASXL, CALR, JAK mutations and other markers have been identified. What we have is several threads to pull on, and it's only a matter of time and research before we understand the nuances of patient response. Money is no longer an issue, b/c JNJ's coffers are full and always refilling. I don't think solid tumor applications will be approved in the next few years, more like 5-10 optimistically, but JNJ WILL pursue them as a matter of business AND science.
My point is that Imetelstat as a treatment for blood disorders is fait accompli. On that alone, Geron will CONSERVATIVELY be valued at $15 billion. And with JNJ's continued research into solid tumors, Geron will have potential like no other small bio. Once JNJ begins research into solid tumors, Geron will be the most sought after bio acquisition. Imetelstat as a ubiquitous, panacea treatment for all cancers, not as a single agent but as a cocktail, will make Geron into a mid-level pharma player, the likes of REGN or AMGN, or even MRK. This is years ahead, of course. But investors right now have a golden ticket near or long term.
True say...
This is why it is a hard stock to trade...
from yahoo...
15 Reasons to Celebrate Orphan Drug Designation
Imetelstat is now approved for orphan drug designation (ODD) vesting it with opportunity for significant development and revenue advantages that provide competitive edge: increased market share, lower development costs, higher pricing, faster returns, and focus on niche markets.
1. ODD now allows use of Imetelstat in primary orphan drug designation (MF) and in any other indication; and is gateway to MF (and other) registry studies.
2. ODD allows for a Fast Track procedure to evaluate registration files.
3. ODD reduces waiting period and provides priority FDA review of new drug applications (6 months instead of 10 months).
4. ODD takes, on average, 30% less time to market (3.9 years vs 5.4 years).
5. ODD allows smaller studies with no placebo required.
6. ODD provides FDA technical assistance during the elaboration of application file and in design of protocols including written recommendations in clinical and preclinical studies
7. ODD has higher rates of approval 82% compared to non-orphan at 35%. Of the 36 new drugs launched in 2013, 17 were ODD.
8. ODD provides availability to patients before market approval when disease is life-threatening, no equivalent treatment is available, and drug in clinical trials and active phase of marketing approval.
9. ODD provides 7 year exclusivity (monopoly) after market approval.
10. ODD provides up to a 50 percent research-and-development tax credit on US trials.
11. ODD waives drug approval application fees and annual FDA fees.
12. ODD application required disclosure of risk/benefit data and
13. ODD allows for development of personalized and predictive cancer treatment that target patient populations with a specific cancer causing mutation.
14. Almost 1/3 of orphan drugs earn more than 1 billion in annual sales. Category has more than 50 billion annually in world wide sales and rising 20% a year past several years.
15. ODD has produced "rolling blockbusters" - drugs initially may be approved for one indication in a small population, but later acquire additional uses after longitudinal studies and real world observations (registry studies).
All investors, traders, and players should do OWN due diligence.
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Also great SA article on subject by (Napodano, 2013). Some highlights:
1. ODD drug in phase I has same liklihood of approval as phase III drug (63%).
2. Stock prices post ODD can go as high as 30% after announcement and 4-5% next week.
3. Applications for ODD are not always made public at time of application.
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Arrowhead Research just got Orphan drug status recently and on their PR . it was mentioned about what orphan drug status can mean for a company .......The FDA Office of Orphan Products Development (OOPD) mission is to advance the evaluation and development of products that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions. In fulfilling that task, OOPD evaluates scientific and clinical data submissions from sponsors to identify and designate products as promising for rare diseases and to further advance scientific development of such promising medical products. Orphan drug designation provides incentives for sponsors to develop products for rare diseases. These incentives include increased engagement with FDA on drug development activities, exemption from all future product-specific regulatory fees, the opportunity to apply for R&D funding, tax credits, an increased chance of priority review, and 7 years of orphan exclusivity at time of New Drug Application (NDA) approval.
Oh yeah...
What it is demonstrating is just how far reaching this could be...
The implications seem to grow as we go...
from yahoo
Pulmonary Hypertension (PH) and Imetelstat
Pulmonary (relating to the lungs) hypertension has been defined as an increase of blood pressure in pulmonary artery, pulmonary vein, or pulmonary capillaries……. the lung vasculature. Pulmonary hypertension can be a severe disease with a markedly decreased exercise tolerance and can lead to heart failure. Pulmonary hypertension is not to be ignored as the NIH registry from the 1980s showed an **untreated** median survival of only 2–3 years from time of diagnosis, with the cause of death usually being right ventricular failure.
In the publication Circulation (2015 Feb 24) 131(8):742-55, Mouraret N et al., investigated the role for telomerase in pulmonary hypertension. They looked at experimental pulmonary hypertension (PH) and its role in controlling pulmonary artery smooth muscle cell (PA-SMC) proliferation.
It’s a preclinical study but they looked at both Human and mice ...... marked TERT expression or activity was found in lungs from both **human patients with idiopathic PH** and from mice with PH induced by hypoxia or serotonin-transporter overexpression. Thus by combining studies of human and mouse lung tissues, mouse cells, and transgenic mouse models, they demonstrated that TERT activation in PA-SMCs played a major role in Pulmonary Hypertension pathogenesis.
To further investigate the mechanisms involved in the effects of telomerase in PH, they used **Imetelstat** as a pharmacological inhibitor and TA65 as a pharmacological stimulator.
Their results were absolutely remarkable to me as TERT inhibition with **Imetelstat** markedly inhibited FCS-induced PA-SMC growth, **abolishing the difference** between cells from mice with PH and control mice.
A potential non-cancer vector for Imetelstat ….maybe the first of many to come.
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United Therapeutics Corporation (UTHR) is the Pulmonary Hypertension company. Their stock has been on an incredible run (~$182). If IMET has a role to play here as a "non-cancer vector", this would be a remarkable application.
In my opinion Bandito, the PPS here is fabricated by the MM play.
They can either supplant the perception that there is mass selling or buying, or the emotions that go with that, and then take their advantage from the panic they cause.
It used to be terrible, with a new release of shares available from the company every so often, that the shorts became a self-fulfilling prophesy...
But it is getting less and less so, and now the reasons for the MM manipulation are changing.
Before all the money to be made here was from trading and shorting.
Now it seems to be trading and accumulation.
I speculate that much of the PPS play we see, is so that some can accumulate at a comfortable pace, and there are larger players here now than ever before.
I do not know of many large players that accumulate a "risky" stock like Geron, and do NOT hedge their bets with Put Options.
Of course this keeps the Short numbers up and leads to other speculation.
As far as I see this now, people want Geron shares. You only need to look at the increase in Institutional holdings that are always going up...
So, do as you will.
Some are buying and holding, and we will see EVENTUALLY, f this ws the right way, here at this time now...
No, can't see any merger as each is stronger being able to focus on their core...
But they are just par for the course these days and not anything negative, in my opinion...
Oh sorry, forgot to say...
Incyte is pretty close to Geron in structure.
Their main drug is the one Geron is about to prove it is superior than...
Incyte
Incyte Corporation (INCY) -NasdaqGS
110.71 Up 2.57
Shares Outstanding5: 179.04M
Float: 162.41M
One might want to consider shorting Incyte, and going Long Geron.
One might also consider how much money will be lost or gained by some people, depending on the success of Geron being able to help cure some people.
There is an extremely ugly side to bio's and pharma, when profits can be focused more than patients...
Hence a lot of the Message Board assaults (yahoo, SI), lawsuits and press releases (adam) against Geron...
So far I believe they have defeated every lawsuit.
The lawsuits are strawmen suits designed to reign in the price when the MM's want to, in my opinion...
Some posts from the yahoo board are focused on what there is, for real, in play. At least as far as I see it too...
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It appears the trial is designed to show imetelstat is superior to the current standard of care (Jakafi) and after only 24 weeks. The trial design is a set-up for accelerated approval. Johnson and Johnson showed their cards last week and significantly reduced the estimated time to market for imetelstat. We are in extremely good hands with JNJ. The JNJ deal is Geron's saving grace.
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FDA approves Jakafi to treat patients with a chronic type of bone marrow disease
First FDA-approved drug for polycythemia vera
For Immediate Release
December 4, 2014
Jakafi is marketed by Wilmington, Delaware-based Incyte Corp.
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Incyte Corp.
focuses on the discovery, development, and commercialization of proprietary therapeutics primarily for oncology. It offers JAKAFI, an oral janus associated kinase (JAK) inhibitor for the treatment of patients with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF, and post-essential thrombocythemia MF. Its product pipe line includes ruxolitinib, which is in Phase III clinical trial for pancreatic cancer; and in Phase II trial for the treatment of breast cancer
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Within 24 weeks we will know if Geron is superior to Jakafi.
If it is we should be awarded FDA approval for even just the patients that Jakafi has not helped...
That is a key part of this to get...
So we are only testing on those Patients that have not been helped by an ALREADY FDA approved drug.
How can they not approve us to help even those people..?
it is brilliant and shows what having J&J and Tefferi on board can do...
All's good in the hood as far as i see...
yahoo, opinion...
FDA Advanced Approval in 6 weeks, After 24 Week Global Tests Start (30 sites, Imetelstat)
"Patient benefits are typically apparent by the third dosage (six weeks after first treatment). Patients showing complete remission have shown reversal of fibrosis and even complete molecular response an astounding feat for a drug with patients who had been faced with near term death after other treatment failures."
JNJ/Janssen will be transparent about the progress of the new global, international trials. The FDA, while still one of the most important approval agencies, there are similar agencies in most countries. The FDA may not be the first to grant advanced IMET approval for the treatment of a basket of blood cancers (MF, MDS, AML).
No worries but worry itself...Relax,
INVESTOPEDIA EXPLAINS 'Confidential Treatment Order - CTO'
Companies would typically seek a CTO in order to keep information that would otherwise put it at a disadvantage, a secret. For example, a company may apply for such an order to keep information regarding a pricing arrangement made with a partner, secret, since competitors finding out this information may go after the partner with a more competitive price.
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Is this all that unusual when there is a partnership arrangement? As I understand it, a CTO is authorized by the SEC mostly to avoid putting a company, or companies involved in partnership, at undue risk from competitors.
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GERN filed the CTO to exclude an exhibit from the 10K statement. That is all.
I could be very wrong, but my sense tells me all of this trading and pps fluctuations are for accumulation.
When I see the spike in institutional ownership, and this type of hot/cold day and control of the pps in a very defined range...
...i suspect that there all of this drama is to facilitate those who are accumulating...
in my opinion...
interesting, from yahoo
MDS Trial Observations....
In the US, the MDS patient population is ~5X the size of the MF patient population, and there are seven (7) different types of MDS diseases with each type being classified as either Low-Risk, Intermediate-Risk, or High-Risk. For reference, the seven MDS diseases are listed below.
* Refractory cytopenia with unilineage dysplasia (RCUD)
* Refractory anemia with ringed sideroblasts (RARS)
* Refractory cytopenia with multilineage dysplasia (RCMD)
* Refractory anemia with excess blasts-1 (RAEB-1)
* Refractory anemia with excess blasts-2 (RAEB-2)
* Myelodysplastic syndrome, unclassified (MDS-U)
* Myelodysplastic syndrome associated with isolated del(5q)
Dr. Tefferi's pilot study involved only MDS-RARS patients. MDS-RARS has been classified as Low-Risk, and MDS-RARS represents only ~10% of total MDS patient population.
In Peter Lebowitz's presentation (Slide 16) today, he clearly shows our upcoming MDS trial will involve both Low-Risk and Intermediate-Risk MDS patients. This is very significant for two reasons....
1) It shows Imetelstat is expected to offer benefit beyond MDS-RARS patients.
2) The combined Low-Risk and Intermediate-Risk categories represent ~70% of the total MDS patient population.
Additionally, we can see from the same slide that Janssen is already planning another MDS trial aimed at High-Risk MDS patients. Thus, in addition to today's other good news & press coverage, we've just learned Imetelstat is expected to offer benefit for a large percentage of all MDS patients.
Also of interest is the MDS trials will not be of the Refractory/Relapsed nature. Thus, it appears they plan to go for 1st line treatment via a head-to-head trial against current standard treatment.
The size of the MDS opportunity has been a lingering question, and today's information is very exciting from both patient and investor standpoint. Given the size of the MDS patient population, this insight may represent the best news of the day.
from yahoo
The real valuation of Imetelstat isn't in MF, it's in the expanded indication list.
MF is a deadly disease, the available treatments target symptoms, w/the exception of SC transplant. But few pts qualify for SCT, there can be a host of complications, and selectivity isn't an exact measure. As for Jakafi, it works for some, fails for others. In the case that it works, it's still not curative; and when it doesn't work, it may contribute to disease state progression.
In contrast to these, Imetelstat put dying patients into CR, which the NCI defines as "The disappearance of all signs of cancer in response to treatment." That's not measured in a few extended months of PFS or OS; this is pts being cured IN PERPETUITY, so long as they stay on Imetelstat. And the CRs were earned under rigorous standards. The change in model of treatment is A TOTAL PARADIGM SHIFT. People who were dying can now live like they never had MF.
Toxicity is real and serious. But it's entirely manageable through dose modulation, as the Mayo trial discovered. And all liver abnormalities resolve w/discontinuation, that's why the hold was lifted. Regarding toxicity in the children's brain tumor trial that Biopearl posted, that trial was designed early 2013, and the dosing schedule wan't all that different from Cohort B in the MF trial, regarding which Dr. Tefferi presented later at ASH as too toxic of a schedule. We know this, we're beyond this. The progress is on the Cohort A results. Now the goal is fine tuning the dose and finding selective markers.
I'm saying all of this just to put a point on why approval for MF is a given. Take into account the chasm between Imetelstat's virtual cure and SOC symptom relief, and you'll get why Imetelstat will be fast tracked with SPA, and the FDA does allow sale during P3. Best case, we'll see sales revenue during P3, and milestone payments too. Either way, approval in MF is fait accompli.
The real question is how the indication list might expand. JNJ will run dozens of parallel trials. Measure Geron's valuation in multiples of MF value.
Ride'em Cowboys...
I sometimes wonder what will happen to some people's souls when they pass...
Trying to hinder those working on relieving many other people's terminal suffering, and all the associated pain of their loved ones, has got to be one of the most heinous investment strategies there is...
Nice list,
The Shuman Law Firm Investigates Geron Corp.Business Wire (Mon, May 11)
Harwood Feffer LLP Announces Investigation of Geron CorporationPR Newswire (Wed, Apr 29)
Schubert Firm Investigates Company's Top ExecutivesPR Newswire (Tue, Apr 28)
Law Offices of Howard G. Smith Announces Investigation of Geron CorporationBusiness Wire (Tue, Apr 21)
Look at the Nasdaq web site. Institutions have picked up more GERN in the last 2 days. Institutions have added 6,086,156 more GERN shares.
27,000,000 shares, GERN short holders are in big trouble here. Even a blind man can see this train coming.
The Imetelstat (IMET) Dilemma, and the JNJ/Janssen (JNJ) Partnership
Investors, in general, have avoided Geron's stock for numerous reasons that have been discussed in detail. Geron is now a JNJ partner, and the IMET team (Janssen-Mayo-Geron) is deep and strong financially, medically, and scientifically. Geron's problems of the past are gone, and IMET's excellent future seems assured. We are all waiting for Dr. Tefferi's presentation in Istanbul, representing the team.
1. IMET has passed every test that it has been given, and Mayo Clinic has shown that it safe and effective in MF (Tantamount to a Cure).
2. JNJ, as a Geron, partner, is setting up global trials to show the "power" of IMET (24 weeks, comparison with Jakafi)
3. The needs of the patients have the top priority for everyone including the FDA and similar organizations worldwide.
4. The basket of blood cancer cousins all appear to be responding sucessfully to IMET (MF, MDS, AML) alone and with combination drugs (including JNJ's own).
We finally received the recognition and not only stating Imetelstat but also stating that it has the potential to generate over 1 billion in sales....per year
now....we are only talking about MF...then there is phase 2 for MDS and AML and potential combination therapy...
what a great day...what a great announcement...and JnJ plans for Imetelstat to be one of their primary growth drivers for the next several years...
IMHO ...I see a lot of revenue coming in the near future....
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Some simple calculations...
For every Billion of revenue JnJ brings in, I think we get 15 or 20% of that...
Let's go with 15%
that is 150M, less some admin and other costs...100M profit
divided over 157M shares, equals $ 0.6369 per share profit...
per billion. I think there will be several billions once this gets moving...
at a 35 to 1 PE per billion...we're looking at about $ 22/share/billion of revs...
In my opinion, this stock will be over 100/share if the medical tests do as expected...
Investor Investigation of Geron Corporation (NASDAQ:GERN) concerning possible Wrongdoing
Notice how they put a Capital Letter on the W of wrongdoing..?
Why would that be capitalized..? Not a person, place or noun, if I remember correctly...
Nope, there is only one reason why a person that has been sufficiently educated, presuming lawyers are, why they would use a capital letter there...
...is solely for attention...
All fluff, imo...
Subs...
I think there are 6...
But the funny thing is, is that they are all for 35,000 shares...
This is par for the course before a big upside...
BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY BUY
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Yup and here might be why...
7:30 am Today, May 20, J&J / Janssen Press Release Highlight Re: Geron's Imetelstat
"At a meeting today with industry analysts, senior leaders from the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) will announce plans to file for regulatory approval of more than 10 new products between 2015 and 2019, each with the potential to exceed $1 billion in revenue1, as well as more than 40 line extensions of existing and new medicines.
Late-stage products expected to drive growth in the next several years, following regulatory approvals, include daratumumab for multiple myeloma; sirukumab for rheumatoid arthritis; guselkumab for psoriasis; JNJ-927 (ARN-509) for pre-metastatic prostate cancer; imetelstat for myelofibrosis; ..."
interesting...from yahoo
BofA Slide Show Cliff Notes: 8 Facts
Slide 3
1. A novel and transformative oncology product candidate.
2. Broad development of MF, MDS, and AML as PRIMARY indications [emphasis added].
Slide 7
3. Co-efficient 2+ (note the +): CR/PR and CI, anemia response, duration of responses, overall survival.
Slide 9
4. Primary analysis at 24 weeks gets quick reporting.
Slide 11
5. "Spleen response in Janssen study and symptom response were basis for Jakafi study." Note: Spleen symptom response reflects current validated regulatory pathway. (Irish Translation: The 'Get Jakafi' Study Clause or Can You Say BAT?)
6. Secondary endpoints capture "depth of responses". (Irish Translation: Dr. Scarlett likes to dive deep and GTJ are not playing.)
7. To enable differentiation of imetelstat efficacy as compared to JAK inhibitors. (Irish Translation: We win! Using Jakafi patients as own control group: response on JAK inhibitors v. response on Imetelstat at 2 dosages.
8. To support imetelstat as highly innovative and potentially transformative. (Note: There is the word - t word - again).
Jakafi has never achieved any of these "secondary" Co2+ endpoints. Imetelstat has done so in multiple patients in 24 weeks over the course of 2 years with minimal side effects compared to traditional "chemo" or Jakafi.
So, in other words, we will see your spleen shrinkage and raise you a CR+. All in now. May the best drug win.
PS Thanks to Imetelstat on Facebook doing an awesome job of sharing information
from yahoo...a woman whose husband was/is part of the trial...
By the way, some of you were following Joanne's MF blog. She left the IMET trial during the FDA hold last year. She then took Interferon with bad side effects. Then, back on Jakafi that she was currently taking. Did better symptomatically for awhile but no disease modification. According to her blog, she now also has large B-cell lymphoma in addition to MF. There is no treatment for MF and serious chemo for lymphoma only complicates her illness further. Only hope for many MF patients is IMET. John who is not on any medication other than the fumes of Imetelstat is still stable and feeling good. No lifestyle changes or medical interventions. IMET definitely slowed disease progression but he would be even better (and safer) back on it. He does not have any other options if the disease progression accelerates again (not yet - but pushing the envelope now). I am guessing it bought him 15 months - the same amount of time he infused before it will get critical again. By the way, hay only covered the tip of the Jakafi side effects iceberg in his post