Oil has yet to bottom, WAKE UP!
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Seems like a no brainer to me
I have been saying if OS results are bad we will see the next RS and all resources pushed towards Tesetaxel. I sold today on horrible OS results and took almost an 8k loss. The risk was worth taking.
Only if your the one behind :)
Volume is exploding again, looks like a volatile close even lower.
Yeah sell company pay off note holders, current shareholder will be left with nothing, kinda like a bankruptcy, but not really.
As I have posted before if OS results are bad expect to loose 85-90% of you investment. Already cut my losses earlier.
With the absolute worst management Genta could possibly have expect the worst decisions to be made in regards to new financing and Testaxel.
Yes what some people thought was a bottom forming was just some speculative sucker bump, just enough for me to take my big loss I see a collapsing towards one cent. If we fall through a penny, expect a reverse split very soon and the greatest note holder conversions this company will ever see.
Holy Sh*t the shares for sale on the ASK are really stacking up at these levels, looks like another big sell off coming.
Outstanding shares will easily exceed 300 Million before ASCO and this time around I foresee a 100:1 reverse split in the near future.
My Pitch: "Manipulation and Dilution is the name of the game. GETA is just becoming more worthless by the day. Remember we can still drop to sub-penny levels. Good Luck"
Jul 29, 2010 05:09 PM
Still true to this day!
Source: http://investorshub.advfn.com/boards/pitchesbyboard.aspx?board_id=970
I see us going to sub-penny levels again, before Genta is forced to initiate the next RS soon and push remaining resources towards Tesetaxel.
Dropping another 30% tomorrow will put a smile on my face :)
It's hard to see how this company can push Tesetaxel with no financing. If the data from Tesetaxel is not impressive maybe the best thing they can do is sell the company and give it a rest.
So I lost almost $8,000 today and ended up with $4310 after selling Genta @ $0.0173
In the near term I see us dropping much further, possibly the next RS very soon.
Good Luck to the rest of you. Time to move on to other investments. Genta was defiantly worth the risk, but good thing I only invested money that I don't need to live on.
Much higher than we are now, for sure if OS is statistically significant. As Bernie said before the market cap of this company is currently pretty much equivalent to the cash Genta has.
$0.0429 * 171,598,071 = $7,361,557.25
The PPS does not have any of the drugs, research, potential for Tesetaxel or Genasense priced in.
Completely wrong, totally blind to the upside Positive OS results will bring(ie: prompt NDA, partnership, immediate increase in PPS forcing fixed returns for noteholders, and eventually FDA approval)
PFS is insignificant compared to the most important results Overall Survival!
With the current OS that would only make us about a 49 billion dollar company, Apple would still be 6 times bigger than that. These guesstimates are overly optimistic and more like a dream at this point.
If Genasense and Tesetaxel were to get approved and go to market, few years from now becoming a Genta millionaire is a possibility, but until then it's simply a dream.
I listened to the replay and this is exactly what Ray said:
"only two patients have been lost for follow up"
I guess you can interpret that several ways, given the up-beet mood in the CC and emphasis given on the matter. Loosing only two patients must be an important positive.
Until we get the OS results, we'll probably just trade here in limbo. I guess speculators have already taken there position and with note holders there will be no run up, un;less we get positive OS.
I believe so, not sure, volume was kinda low on my end and who knows what we missed in the disconnections. Gonna have to listen to the replay in a couple hours.
I think in the near term we may actually have a run on this stock as speculators take there positions also there was less dilution(note conversions) last week. Outstanding shares about 166 million.
Yes seems like they have prospective partners lined up and statistically positive OS results would bring about a predetermined partnership and prompt NDA.
Ray sounded pretty confident throughout the CC. What do you guys think?
Anybody else experiencing problems with the conference call? I hear a lot of blank like a disconnection for several seconds while they talk.
The trial is based on overall survival and only 2 people died.
According to Google Genta posted this PR May 14th, but quickly removed it. I guess that noodls.com may have caught a copy of it. See for yourself:
http://www.google.com/search?q=http%3A%2F%2Fwww.genta.com%2FPress_Releases%2F2011%2FGenta_Incorporated_Reports_First_Quarter_2011_Corporate_Highlights_and_Financial_Results.html&ie=utf-8&oe=utf-8&aq=t&rls=org.mozilla:en-US:official&client=firefox-a
Unfortunately there is no Google cache of the page but it shows in google that it did exist recently.
Not a dead link but a blank page:
http://www.genta.com/Press_Releases/2011/Genta_Incorporated_Reports_First_Quarter_2011_Corporate_Highlights_and_Financial_Results.html
Must be a financial statement leak.
Fake PR or Leaked financials?
If you google any part of the press release you will see it's only posted on IHUB and noodls.com
But there is a dead link to Gentas website:
http://www.genta.com/Press_Releases/2011/Genta_Incorporated_Reports_First_Quarter_2011_Corporate_Highlights_and_Financial_Results.html
Interesting.
Absolutely correct. Third times the charm. I would give us a 70% chance of a statistically significant Overall Survival results.
Hundreds of millions of dollars, years of research, years of investor and patient pain will culminate in the most important event to date in Genta History, OS Results for Agenda.
Many investors have lost most of there money already getting to this point or have cashed out waiting on the sidelines. Takes balls to hold a position during this very crucial time, with a early CC Monday literally anything can happen.
Peasodos
Agenda trial concluded this month and we are awaiting THE most important results, OS data.
Good results and market cap will quickly adjust to the tremendous value Genasense will bring. Along with NDA and FDA fast track approval. The PPS will adjust literally overnight and note holders will have there debt called upon for the fixed return shortly after. If OS results are significant theirs no doubt FDA will approve Genasense this time around.
On the flip side, statistically insignificant results will bring about the next R/S and massive noteholder conversions. Genta will probably do another round of toxic financing to push Tesetaxel to phase III. Anybody holding shares after the bad new will loose 80-90% literally overnight.
After insignificant PFS, why waste tens of millions of dollars to continue the Agenda Trial? Why not put Geasense in the grave right away and focus all resources on Tesetaxel? The reason is researchers have seen something significant that Genasense has to offer, even in the trial prior to the first NDA, Genasense hit it's primary endpoint. Genta has learned a lot from the past trials and are very confident Genasense will show positive OS results in patients with a low to normal LDH.
Peasodos
Genta Trades in Europe?
What Exchange?
What is the ticker symbol?
Anybody have a link?
Peasodos
That would just add to the rise in PPS if results are good, could be one hell of a short squeeze.
It takes real balls to short Genta with OS results right around the corner, I envy those guys in a way, even though I'm betting against them.
Peasodos
Maybe we'll have a last hour run up like last Friday as investors take there positions for Monday's CC, literally anything can happen.
Peasodos
If you really believed in Genta you would have at least added more at these levels. Your cost average is probably very high and would most likely regret not buying if you end up recovering the original investment in a few years if OS results breathe new life in this company.
I applaud the company for doing the toxic financing because it has gotten us to this very crucial point. Success or failure we will find out soon when overall survival result hit the wires.
Defiantly one of the highest risk investments one can take, I don't think you should be a shareholder since your risk tolerance is very low.
Peasodos
Volume this past week really shows that conversions have really slowed down. It's safe to assume the overwhelming majority of note holders are holding.
Peasodos
What your saying makes a lot of sense.
Another black Friday and then early CC Monday to announce new RS taking place. They already have the results and may have been holding on to come up with financing to push Tesetaxel. Looks like a setup for the grave of Genasense.
Or maybe the results are outstanding and Genta has been working with another drug company to partner on Genasese to push forward a NDA and development of the drug. So maybe great news about OS results on Friday and partnership/financing/NDA news early Monday.
Looks like we are setup to go either way at this point. Good luck to all of us, personally invested just over $10,000 around $0.05
Has yet to be released, if we get no news tomorrow I foresee speculators to take over and we get a nice solid gain.
$5 and I become a Genta Millionaire. Long shot from here but if OS results are outstanding the potential for this drug is huge.
If the Overall Survival results are significant maybe FDA will reverse it prior decision. Well that's a long shot.
151,338,423 Outstanding Shares
http://www.sec.gov/Archives/edgar/data/880643/000143774911002903/genta_8k-050611.htm
Gross man, that's like a grandma. IHUB needs to censor that clevage.
Yes Tesetaxel looks really promising and I applaud the company for going full force and starting so many new trials.
But if Agenda trial shows at least 12.5 months of overall survival it will breathe new life into the company. Third times the charm, hopefully.
Without Agenda showing some success I see note holders converting more aggressively and forcing the next reverse split and us investors getting screwed again despite any success in Tesetaxel.
Peasodos
What the AGENDA trial needs for Approval!
Alright Genta fans, today I am going to run through what kind of statistics I think Genta needs to produce to garner approval from the FDA in the upcoming release of the AGENDA trial results.
First a quick backgrounder on Genasense
Genasense, as most of you already know is in a Phase III trial named AGENDA for patients with normal LDH levels that have melanoma. The drug is designed to be used in patients with cancer that are resistant to certain types of treatment, in this case dacarbazine. It is believed that these patients are resistant to standard cancer treatments because their cancer has a gene called Bcl-2 that resides in the mitochondrial membrane of the cancer cells that blocks the standard therapy’s ability to kill cancer cells. That gene is specifically targeted by Genasense to be inhibited from performing its function which then allow the dacarbazine to kill the cancer. Genta believes that the drug works best in patients with a normal LDH level (LDH is is often used as a marker of tissue breakdown).
So what kind of results will we need to see out of the AGENDA trial for approval. I am going to be bluntly honest with you, they need some pretty startling results, because Genasense has twice previously been in front of the FDA for approval with this drug and in both instances has been shot down. So let’s run through some quick stats that I think will be important indicators for approval.
The Primary Endpoint: Overall Survival or Progression Free Survival?(of course this is always the most important!!!)
Previously, Genta ran a clinical trial in melanoma patients called the GM301 trial, the trial however did not even come close to meeting the primary endpoint of statistical significance in Overal Survival (OS). Genasense only increased overall survival by an average of 1.2 months over dacarbazine with a statistical significance level of only p-0.077, keep in mind when they met with the FDA the p statistic was at p- 0.18. Not surprisingly the FDA’s ODAC shot them out of the water with these kind of numbers and voted for non-approval. However, Genasense has identified a patient subgroup that responds well and released those figures recently. So let’s take a look at them, from the previous trial Genta extracted a subset of patients with a normal LDH level that appeared to respond much better. In fact these patients overall survival (OS) Genta claims is 12.3 months (here slide 14/15) which would put it at 2.4 months longer than dacarbazine’s 9.9 months. See here is the thing that investors should be aware of, there are other studies out there that show that a cocktail that contains cisplatin, vinblastine, dacarbazine, interferon alfa, and interleukin-2 had an overall survival of 11.8-11.9 months (journal here). And these are the studies used in the NCNN melanoma practice guidelines (page 17/41), however it doesn’t seem to be known why these combo therapies work. And they don’t always work the with the same results. So maybe Genta has found the holy grail in that normal LDH patients respond better with their drug. One thing is for sure, THEY NEED TO REPLICATE AT LEAST an 11.8 and up Overall Survival rate in their patient group to garner approval from the FDA. Otherwise the FDA will simply say, “hey why don’t we just give the patients this cocktail, that appears to work better some of the time?”
Next let’s talk about the Progression Free Survival Statistics, because Genta is claiming that the PFS should increase to 3.6 months on Genasense, while patients taking dacarbazine will last 1.6 months. Again a great number, but there are other therapies (paclitaxel plus carboplatin) out there that produce up to 4+ months of PFS in patients with advanced melanoma (journal here), also note this therapy has a ORR of 11% too).
What about the Overall Response Rate
In the GM301 study (here) Genasense actually met this goal, in fact, they completely destroyed dacarbazine by itself. Genasense’s overall response rate (ORR) was 6% higher than dacarbazine’s alone at 13.5% of patients achieving an ORR. It is my belief that this should have been enough to get the go ahead from the FDA’s advisory board, but they voted against it. Why? Recall that previous study I showed you, well read the results again (here). In that study patients have a WHOPPING 64% ORR, I mean seriously that is some tough potatoes to contend with. So keep that number in mind, because even in the normal LDH population Genta only achieves a 20.8% ORR. The other study with the 64% ORR is probably why Genta did not include ORR as one of the endpoints in the AGENDA trial.
What about approval?
So which is the better indicator of approval, OS or PFS? Alright, I’ll just be as quick to the point as I can here. The MOST important thing that matters here is the Overall Survival (OS) rate. You see Genta has already tried the PFS arguement before in melanoma and it blew up in their face. Remember they were rejected by the FDA’s advisory board for a melanoma indication and they were trying to use the PFS as a reason for approval. Add to that, that the other competitor treatments have a PFS of 4+ months and you are really pushing the issue here. We already know that Genasense works to improve the PFS and the FDA rebuffed that, so investors should treat that number as a by-product of the AGENDA trial.
What is really important here though is the OS rate. I know I said earlier that they should have an OS of at least 11.8 months, but to gain approval I think Genasense is going to have to blow the tops off of this one. So if I was investing in this company I would want at least an OS rate of 12.5+ months in the AGENDA trial. Anything less and I would immediately sell the stock. Why? Genta has already tried going in front of the FDA with other endpoints with good data and been shot down. They are not as important, that is why Genta has choosen the OS as their primary endpoint. You see, Genta knows that with the other combo therapies out there showing great ORR (64% in combo sequential therapy) and PFS rates (4+ in some therapies) it will be hard to argue that their drug is better than just plain old dacarbazine. Because in reality patients are going to be attempting the other therapies with the better PFS and ORR rates. I mean who can argue with the 64% ORR that the cocktail data revealed. So for a sure play on the stock, be looking at the primary endpoint to completely smash expectations.
How to read their Press Release when the time comes
Ok, the morning of the press release if you read it and they are only focusing on the ORR and PFS and barely happen to mention the OS rate, then you know the gig is up. The Press Release out of this company should highlight the fact that the OS rate met and beat expectations, anything else will be hogwash. OS rate, remember that is all that matters here.
Wait hold on a minute, what about safety and efficacy?
Ah, you thought I would forget about this, huh? Nope, this is where I am highly critical of Genta, because they aren’t being very forthcoming with the toxicity data in the LDH patients. I have seen snippets here and snippets there, but not enough data to draw conclusions. If you remember correctly in the original GM301 trial (FDA slides 28-30/41 here) you will notice that Genasense increases neutropenia, thrombocytopenia and discontinuation of treatment, none of this bodes well for approval. However, the sequential/cocktail treatment that I have been discussing is actually as rough or even rougher on patients. So what would I be worried about? Safety and Efficacy will not be a concern if Genta smashes the OS rate, it is that simple, these symptoms, while not great, are not enough for a non-approval if the OS rate completely destroys expectations.
Source Geccowire.com