Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
If we see a thumbs up from the meeting scheduled for May. Did not say when on todays PR. In my opinion it should be a lock for one of the approval agencies, due to the fact it is a confirmatory trial for both. To confirm as the EMEA put it in a release, Positive results (confirmation of what they stated was a positive result).
Well just off of some BS math. Not that everything else is equal but if our float is at 2 billion 20 x DNDN. Just off BS nothing else factored in would put us in at a target of 1.50 I think it would be easy for us to hit .50 current float if something big happens in the next month. That is extremely wishful thinking though.
Yes absolutely. A month away, piece of cake.
Found it thx. That would put us around a June / July time frame from the Agenda start for first in patients to this trial, interesting. It would be nice if they do advise for immediate action. Just not planning on it, thinking it is more likely to get a well leveraged financial deal after the review though.
So the way I understand their working formula for the Hazard Ratio is:
1 currently equals 100% chance in advanced disease progression
Genasense lowers this to .64 or a 64 % death rate
Which means we have a survival rate of 36%
What is the time frame they are using to reach 36%?
I will look it up but was just wondering if you already know.
I am guessing it is speculation buying and holding for the meetings. Hopefully we get a good response and this thing takes off % wise like DNDN. Plus we should see movement off of this meeting alone once word has spread. JMHO
At .068 that is a 71000 dollar buy.
Got it will take a look. THX
Just read the last ten posts and you will see. Ok sorry. read 20834
Not only fast tracked but previously turned down and wanting this confirmatory trial. I say again confirmatory. Bio's opinion could be right on.
Hey Bio,
I did extensive research on the EMEA and Agenda. If I am not mistaken it was the EMEA who originally wanted Agenda as a confirmation trial. Do you know what the number of patients they needed to have enrolled in the trial? I believe it was lower than the FDA requirement.
This is correct. :) I did not say this meeting was out of the ordinary.
Sorry let me clarify why would they have a safety and futility meeting (not preliminary results per say) and push back the below?
Why did they move the meeting about R/S till the end of May?
Conflict of the meeting times or something else.
Everyone will have to guess for themselves.
Read previous post this morning sorry was editing it.
Is anyone still confused by why the meeting was pushed back? Nothing new Holder.
As shown in the table below, preliminary information on patient characteristics and safety findings in the patients accrued to AGENDA are similar to those in the biomarker-defined population that was accrued in the previous Phase 3 trial of Genasense, known as GM301.
"The statistical assumptions in AGENDA were derived from a large sample that comprised 274 patients from our completed trial, GM301
People for your own good read more carefully. These are just two short clips but they are telling you they have projected and are seeing this again.
In my opinion only. This is what I have been saying along with others on the board. Why would they do a preliminary results meeting? I believe that they are working on a partnership.
The Data Monitoring Board will convene in May 2009 for its final review of safety and futility analysis, and we look forward to that meeting.
Sorry, but I am going to reply.
Genta if they do get a partner probably would not put out anything till it was finalized. These companies can always go into skeleton mode to save costs so cost burn analysis is not always accurate like in other sectors. They would be smart to wait till finalization before making anything public on a partnership as this can open them up to legal issues if the deal falls through.
I WILL RESPOND IN CAPS SO YOU CAN TELL MY WORK FROM MR. HOLDERS, NOT YELLING.
Dude, ryan, seriously...
...you don't want any piece of me as it relates to Genta and its history. In fact, Genta has never unblinded a clinical study. But, let me give it a shot:
YOUR JOKING RIGHT?
Well ok :)
1) Several companies including Genta have historically kept investors up to date on the current progress of clinical trials. Just do a search of information for companies over the last week. Or you can just look at this forum.
Response:
You can see that Genta clearly has a history of electing NOT to unblind studies, here's a snippet from a 2004 Downgrade of Genta...it still very much applies today:
-Uncertainty Around Two Remaining Genasense Trials. Genta has also conducted two other Phase III trials for Genasense, one in chronic lymphocytic leukemia (CLL), and another in multiple myeloma (MM). Genta elected not to unblind either of these trials ahead of the regulatory outcome for Genasense in
melanoma. We expect that, if the panel indeed recommends against approval,Genta will switch gears and unblind one of these two trials. Given the highly competitive nature of the MM market (Thalomid, Velcade), Genta may decide to
release the CLL trial first, although the company has refrained from issuing any specific guidance. While there was some single agent activity noted in a small, uncontrolled CLL study, the uncertain outcome of both trials increases the risk
profile of Genta.
GENTA DOES HAVE A HISTORY OF KEEPING INVESTORS UP TO DATE. PEOPLE JUST NEED TO RESEARCH PRNEWSWIRE, COMPANY WEB SITE ETC.
Now Mr. Holder since you are so critical of people who actually have some knowledge, here is my challenge.
Why is the short IV infusion program for Genasense important?
Answer:
Genta realizes that the administration schedule of current Oblimersen injections is terrible at best and has been a major roadblock in regulatory approval. It has to be administered for hours and hours (I believe 8 hours straight via IV) and causes injection site reactions, not to mention overhead in the form of hospital care. The new infusion program is looking at a new way to administer the drug to improve all of the above.
WRONG. THE NEW ADMINISTRATION PROVES THAT THE DRUG CAN BE ADMINISTERED IN SHORT MASS INFUSIONS WITH NO TOXICITY REACTIONS IN SUBJECTS. IT IS BACKING UP PREVIOUS DATA STUMBLED ON DUE TO ERRORS IN ADMINISTRATION IN A PORTION OF PREVIOUS TRIALS. THE IMPORTANT NOTE IS THE LACK OF ANY TOXIC REACTION IN PATIENTS WITH STILL THERAPEUTIC GAIN.
Why is Agenda so important to Genta? Not from a business standpoint but a developmental one? (hint: Indication for use.)
Answer:
The Agenda Trial is important for several reasons. TRUE
Number one, it's their last shot at getting their leading compound to market.
I WOULD CERTAINLY DISAGREE.
Number 2, being able to replicate the previous phase III study results in the low to normal LDH responders would be a major step in getting the drug approved for the treatment in of melanoma patients with that biomarker.
ALTHOUGH THAT IS TRUE, WRONG ANSWER. IT IS SIGNIFICANT IN THAT THEY WILL BE ABLE TO NARROW TREATMENT TO A SPECIFIC GROUP OF PATIENTS. IN TODAYS CANCER TREATMENT REGIMENS ARE TAILORED TO SPECIFIC PATIENTS, AND EVEN THEN THIS DOES NOT WORK FOR ALL. THIS IS WHY CANCER TREATMENT IS NOW CONSIDERED ON A PATIENT BY PATIENT BASIS AND THUS THE BIG PUSH FOR MORE DRUGS IN THE TOOL BOX. IT WILL IF PROVEN CORRECT ALLOW TREATMENT OF PATIENTS WITH LDH ANOTHER DRUG IN THE TOOL BOX.
Number 3, if it isn't successful, the company will be out of business and in debt at an amount that their childrens, childrens, childrens, children will never be able to pay back. Finally, regulatory approval will open the door to the treatment of other types of cancer.
WRONG. YOU NEED TO DO SOME BUSINESS RESEARCH OR RUN YOUR OWN. GENTA IS A CORPORATION AND THUS IS CONSIDERED ITS OWN INDIVIDUAL. IF GENTA GOES OUT OF BUSINESS THAT IS IT NOBODY WILL OWE EXCEPT THE COMPANY ITSELF. WHICH WILL BE SOLD OFF FOR PENNIES ON THE DOLLAR.
Who were the the individuals at the NDA for Genasense in CLL from the MD Anderson Cancer Center? Why is this significant? And what was the final vote?
Answer:
What are you talking about NDA? Are you talking about where the oncologists were removed from the panel and replaced with other non-oncology experts? The final vote was 7-3 or something like that not in favor of approval. But we all know what the outcome was...why are you asking this?
YES THE VOTE WAS 3 FOR AND 7 AGAINST. NEW DRUG APPLICATION. LOOK UP THE DOCTOR THAT WAS THERE FROM MD ANDERSON AND DO SOME READING. IF HE IS SUPPORTING IT THAT IS A BIG DEAL. ALSO THERE WERE SURVIVORS AND NUMEROUS OTHER INTEREST THERE ON GENTAS BEHALF.
You seem to think I don't believe in the drugs or their applications and you couldn't be more wrong. The problem is in their finances. They're out of money and under the current financing agreement, will have to reverse split by June in order to obtain the remaining 6MM to stay in business and see the Agenda Trial through end-to-end.
YOUR STATEMENT ABOUT THE CORPORATION AND HOW MUCH WOULD BE OWED CONFIRMS YOUR KNOWLEDGE IN CORPORATE MATTERS.
Well ok :)
Several companies including Genta have historically kept investors up to date on the current progress of clinical trials. Just do a search of information for companies over the last week. Or you can just look at this forum.
Now Mr. Holder since you are so critical of people who actually have some knowledge, here is my challenge.
Why is the short IV infusion program for Genasense important?
Why is Agenda so important to Genta? Not from a business standpoint but a developmental one? (hint: Indication for use.)
Who were the the individuals at the NDA for Genasense in CLL from the MD Anderson Cancer Center? Why is this significant? And what was the final vote?
I look foward to your DD so everyone can read.
Thank-you
LOL Dude you really need to do some research on clinical trials.
And remember also that MD Anderson Cancer Centers doctors have supported this drug from the beginning. I think now that they are narrowing the patient field it works on it will be getting approve. JMHO
Narrowing it to who it works on is extremely important. It allows doctors to customize a patients treatment regimen. Which in the doctors opinions from what I have read and listen to on their radio cast is huge.
Just my opinions
Well since entering at .003 I have made alot more, do the math. If you have made 400% you would be happy. Oh yeah, so when are they going into BK. Please refresh us. I am done with you today.
Thank you for proving my point. You made a bad investment while other people made a good one and now you are pissed.
Learn from it and move on.
Yeah I know. I have been watching him for awhile. I find his posts funny.
What is even funnier is the talk of how much DD he brings to the board.
I encourage everyone to look back at his past posts and you can see for yourselves.
Good news. Why would you waste money on a patent if it did not work. Pay attention people.
Something tells me that you at some point lost your butt on this stock. That is bad planning and investing, move on and learn.
I keep hearing separate the company and the stock. What? The stock and company are tied together. If the company is successful the stock rises and if it does not the stock also goes down. This is investing 101.
LOL
Wrong about what? The company can and will update whenever they feel it is responsible to do so. Just like any company out there.
We know it was a 28k block that was bought, however we do not know if it was a single sale at that amount, a larger one or multiple smaller ones.
Found a discussion on melanoma and advances in care from MD Anderson. About an hour long and I think around a year ago. Still listening to it. Thought you all might want to check it out.
http://www.mdanderson.org/about_mda/patientpower/display.cfm?id=36ad1bad-1685-4e59-aded8513deadd60e&method=displayfull
Unless I am wrong I thought naked short selling was illegal on all US exchanges. This is because you are selling the purchaser something you do not have (fraud). This is why if they did it they would do it in Germany where they do not have to worry at all.
Actually if they are naked shorting it they would do it in Germany. We are listed in Berlin. SEC can't touch them and they give a B/S story when the numbers do not match up till they cover.
Dan,
That is pretty funny. Why would you go through 15-20 reverse splits. I think you would have learned along time before then if they all worked out bad and dumped your position.
Your story has more holes in it than swiss cheese.
Gary I believe we will have a partnership.
If we do not have a partnership I am expecting a share repurchase from revenue in the future to reduce the float. I would not anticipate the float be kept at 6 billion even after revenues from the drugs come in.
The second would require me to hold my position for a long time. That is ok with me, free shares at this point.
I don't think people are seeing the big picture, they only see the now.
I do not know why people would call this bad news. The fact that the CEO wants to wait till the end of Agenda before even trying a rs. This will give them time to get everything in order. And if they do not have the best relationship with the FDA that is ok, things change people come and go. This would give them more reasoning to bring in a partner, just would give them more leverage in my opinion. Also seeing is how the FDA says they want a confirmatory trial, this indicates along with Bio's conversation that the FDA is feeling the heat on this now.
Long story short person conflicts are part of life. The FDA has been dirty for a long time and in the past months it has been under the microscope. So to me this makes for the perfect storm for Genta.
Between that, the dates being pushed back and the PR. Coupled with several patents filed in the last couple months. I think we do indeed have big news around the corner.
I think that is a good guess. We are through the 200 ema figured at 5 minutes. With some good volume.
Holder,
Although you may think so, the market thinks different. I know I do not have to tell you don't fight the trend.
I am agreeing with you I am just presenting the far extremes on both the right and the left.
They are silly, I agree. But no more silly than some of the negative posts with outlandish tales of .002
No offense to anyone. You all can trade how you want. But why would I day trade on little moves like this. When I can short term trade the real movers over the last two weeks and make over 100% return. And still keep a long position in GNTA.
Or I could day trade GNTA and make far less in two weeks.
Lets just say he has hit the mark in the past. None of the nay sayers have yet. Don't get me wrong they have come somewhat close but overshot their estimates pretty large.