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I agree with you about that Gary. not unusual behavior from bundle.
I see another testing starting around 2:00-2:30.
Will try to break .90 and if it does $1 is next.
I would like to hear what p4p has to say though as well.
I agree Bernie. 1.075-1.125 close
COME ON!!! 86 AND ITS OVER FOR SHORTS!!!
@Smitter - 9/16 Shares Owned My Calculations: 140,412,145
Raymond P. Warrell, Jr..................48,184,785
Cat Trail Private Equity Fund LLC...17,754,451
--667-1,2, 14159,
--Baker Brothers Life Sciences, L.P..16,968,279
BAM Opportunity Fund LP..............13,476,214
Loretta M. Itri...................................12,315,425
Tang Capital Partners, LP..............11,766,912
Arcus Ventures Fund.......................10,503,366
W. Lloyd Sanders..............................4,413,365
Gary Siegel.......................................2,942,134
Douglas G. Watson...............................695,858
Christopher Parios...............................695,698
Daniel D. Von Hoff...............................695,658
Boxer Capital LLC (Tavistock)..................??????
Rodman and Renshaw LLC.......................??????
Rockmore Investment Master Fund Ltd........??????
Cranshire Capital LP.................................??????
RRC Biofund LP........................................??????
Total Shares......................................140,412,145
Shares Outstanding 9/15/09...............169,684,485
Percent of Outstanding Shares...............82.75%
My calculations from the SEC fillings are at around 140M owned out of the 170M outstanding.
Ray and Loretta alone have like 50M~ combined.
If genasense is approved, IMHO it is $20+
Testing .73 Again. Power Hour Won't Fail IMHO.
This looks good. We are above the 200...and the 20 is now on its way back up. I think we can do it. I didn't think so an hour ago.
I do not subscribe I cannot private reply. What's up?
I too agree with .59 having a lot of resistance there. Would be nice to see a little HOD spike and catch the MMs off guard.
@Bernie. Golden cross with what, the 50 and the 200?
By the end of next week we can sustain price above the 200ma for sure imho
Thanks Bernie. Yeah I'm not much of a chart guy myself either. Thanks for the info though. Let's hope the end of the day treats us well!
Oblimersen is Genasense, yes, a Genta Drug. You can see ITRI LM at the top there, that's Loretta. Ray's wife.
Bernie I agree i think we could see .70 during the end of power hour. I would LOVE for this thing to close at HOD...higher than the current .625/.63 High that we are at right now.
imho $5-8 after AGENDA data and then after partnership $12-17 and big resistance at 20 until actual approvals
My Calculations: 72.75% of Outstanding Shares Accounted For
OK. I got these numbers from the most recent 13G's and 4's. My first thread that i made on the other boards was wrong. Before I had said more like 60% and now its 72.75% of shares accounted for. We actually know almost 75% of the shares and where they are. And, thanks to the list of financers in an earlier SEC filling for the $13M dollar tranche, we know that there is still more to come.
Wow?
Raymond P. Warrell, Jr..................48,184,785
Cat Trail Private Equity Fund LLC...17,754,451
BAM Opportunity Fund LP..............13,476,214
Loretta M. Itri...................................12,315,425
Tang Capital Partners, LP..............11,766,912
Arcus Ventures Fund.......................10,503,366
W. Lloyd Sanders..............................4,413,365
Gary Siegel.......................................2,942,134
Douglas G. Watson...............................695,858
Christopher Parios...............................695,698
Daniel D. Von Hoff...............................695,658
667-2 (Baker)..........................................??????
667-1 (Baker)..........................................??????
14159, L.P. (Baker)..................................??????
Baker Brothers Life Sciences, L.P.............??????
Boxer Capital LLC (Tavistock)..................??????
Rodman and Renshaw LLC.......................??????
Rockmore Investment Master Fund Ltd........??????
Cranshire Capital LP.................................??????
RRC Biofund LP........................................??????
Total Shares......................................123,443,866
Shares Outstanding 9/15/09...............169,684,485
Percent of Outstanding Shares...............72.75%
How long from now?
Ok, So, What is up with this stock? I'm still holding. But anyone, someone, wtf is going on here haha
I've got a link to the Overall Survival slides that people on yahoo have been requesting so I am posting it here as well.
http://i29.tinypic.com/3339v87.jpg
It really, really, makes you feel better about your investment when you can see EORTC's data. Imagine that! 0.0009 Overall Survival compared to GM301's 0.077!!! AGENDA will surely pass the p=0.05 for both PFS and Overall Survival.
I'm glad they made this slideshow.
EORTC Overall Survival Data Passed By A Mile
Smitter...anyway I can get this ONE POST PER DAY BAN off of my account?
Overall survival from the FDA for AGENDA requested that it be less than 0.05. EORTC is the european "agenda" trial that finished in July 2009.
GM301 (last phase III trial)
Overall Survival = 0.077
PFS = 0.0007
EORTC
Overall Survival = 0.0009
PFS = < 0.0001
AGENDA
??? We must wait. But MAN 0.0009 OVERALL SURVIVAL FOR SOMETHING COMPLETELY SIMILAR TO AGENDA! THAT CRUSHES 0.05!!!!!
I got this information from slide number 7 and 11 from the Rodman Renshaw conference yesterday.
Ray said on the conference call that "MOST" of the notes were locked up (he meant all but the august/september tranches) and he even went as far as to state "these are forward looking statements" when talking about shares outstanding and convertible debt.
he is in no violation of anything he played it perfectly well, and he obeyed all the rules.
Well, it could be just because there was 125 million shares traded around 1pm and the average 10 day volume is 2 million. they could be dumping shares onto the market. I'm still holding right now with 73333
Brick - NWTT Opinion going into power hour???
Turning over the float is a bad thing though, isn't it?
Scottrade made me call them to place order. It is halted from retail online trading i guess. i mean the spike in volume explains it.
they could be dumping shares or they could be going up, who knows?
I took at gamble at 0.0003 73000 shares
NWTT - I took a gamble at 0.0003 bought 73000
The first 45 out of 50 trades were BUYS back when it was at .0085. This dip is not the end. I'd buy if I had more money to put in it.
Why did you say all morning that PM would bring another pop..and now you are all like..."I HATE THIS STOCK IT WONT MOVE EVER
Is it moving because Israel might attack Iran this week?
Stock Should Be $10 By Xmas Here's Why
This is why the stock should be trading at $10:
Ray said in the conference call: "Parenthetically, it has hardly escaped our notice that during the past quarter, Bristol Myers has paid $2.1 billion dollars for the HALF, that would be HALF, of the melanoma drug from Medarax that they did not already own, a drug known as Ipilimumab, also a compound that is pre-data."
He made sure that he noted, TWICE, that Bristol Myers paid a whopping $2.1 BILLION for only HALF of a drug...that DID NOT EVEN HAVE DATA!!! ... WE ARE GOING TO HAVE DATA BY VETERANS DAY, and Ray said that they have suspended Genasense talks until the data is out!!
He WOULDN'T have hinted at this if it meant nothing...
$2.1 Billion dollar market cap at 133.7 million shares = $15.70
(even if you thought the dilution would make it DOUBLE the outstanding shares, its still an $8 stock based on the potential sale price of Genasense alone)
If you don't get it, I'm implying that a WORSE drug that LACKED the data that we have, was purchased for 2.1 Billion$...and that was only HALF of what it was worth.
So if Genasense get's purchased...even only have...it should be LARGER than 2.1 Billion in CASH...and that ALONE would propel us over 15$ at this many outstanding shares....
So Ray was implying that our BETTER Genasense drug would sell for MORE than 2.1 Billion for half....
So if you factor NO OTHER INFORMATION from the company, and just the cash that they would get in a BAD deal for Genasense...that's 2.1 Billion dollar market cap.
This thing is going to explode, eventually. Basically Ray just said bidding starts at $2.1 Billion dollars once the data comes out. And that SEC filing said that the financial decision for the company would be out 14 days after the public announcement of AGENDA results.
In reply to vawedo and 2.1 Billion Dollars...
Ray said, direct quote: "Parenthetically, it has hardly escaped our notice that during the past quarter, Bristol Myers has paid $2.1 billion dollars for the HALF, that would be HALF, of the melanoma drug from Medarax that they did not already own, a drug known as Ipilimumab, also a compound that is pre-data."
Genasense is going to have data. And we have a better drug.
@smitter I only have one post left..any way to lift this from me?? i appreciate you sticky-ing that post earlier but if you are going to sticky one of them, sticky my conference call transcription :)
Written Transcription of Ray's Prepared Statement from Conference Call
Took me two hours...I'll tried to do the Q & A later...that had good partnership information in there. FYI doing this has allowed me to learn that there is no conference call on august 26th. enjoy this, its great when you can read it, and i know 90%+ of you didn't listen to the call. This was transcribed to the best of my, ryjo8831's, ability and is obviously unofficial.
At 5 minutes and 27 seconds into the conference call, CEO Dr. Raymond Warrell speaks:
Thanks, Gary. I’m going to focus my remarks primarily on clinical developments, and then provide some comments on our financial status.
As most of you know we completed enrollment into our Phase III trial of Genasense in patients with advanced melanoma known as AGENDA. A total of 315 patients were ultimately accrued in this trial, these patients derived from sites in the U.S., Western Europe, Canada, and Australia. The goal of this study was to replicate findings observed in our previous trial, using a biomarker to define a potentially chemotherapy sensitive population. Our prior trial, known as GM301, achieved all of its secondary endpoints, including Overall Response and Progression Free Survival (PFS), and it narrowly missed its primary endpoint of Overall Survival, which was numerically superior, but with a p-value of 0.077 for the entire population. Our subsequent analyses show that low LDH, a readily available blood test that we used for stratification in the last study, was significantly associated with improved survival. Moreover, this outcome was observed in a population comprised of more than 500 individual patients. The importance of LDH as a powerful prognostic factor had already been well established.
This past quarter the EORTC, which is Europe’s largest oncology cooperative group, published their findings that validated the impact of low LDH in a completely independent group of study patients who had received completely different types of chemotherapy. Thus, all of these factors and the robust sizes of the populations on which these observations were based combined to increase both the importance of our findings, and also to make it unlikely that our observations were due to chance or to post hoc analyses of patient subsets. It is these analyses that form the basis of the projections that were developed for the AGENDA trial. AGENDA was double blind, and entry was restricted to patients whose baseline LDH did not exceed 80% of the upper limit of normal. This latter change in particular represents our major effort to hyper-enrich the study for patients who are maximally likely to benefit. With closure of enrollment, our blinded and blended update indicates that patients accrued into AGENDA were very similar to patients with low-normal LDH in the preceding study. Moreover, during the past quarter, the independent Data Monitoring Board for this trial conducted an important post-accrual analysis for safety and futility. Those of you who follow recent developments in melanoma will recall that during 2009 two similar futility reviews sunk the most recent Phase III drugs in melanoma, namely Elesclomol from Synta, and Nexavar from Onyx and Bayer. Thus we were very pleased that the Genasense analysis passed this key review point, and that the committee recommended that the trial continue to completion. Parenthetically, it has hardly escaped our notice that during the past quarter, Bristol Myers has paid $2.1 billion dollars for the HALF, that would be HALF, of the melanoma drug from Medarax that they did not already own, a drug known as Ipilimumab, also a compound that is pre-data.
I want to provide our expected timeline of events. AGENDA has co-primary endpoints that are hierarchically ranked. The first is Progression Free Survival, or PFS. The second is Overall Survival. We currently expect to conduct the PFS analysis approximately six months after the last patient was enrolled. We are completely on track to have a sufficient number of progression events that will generate this primary analysis, and we will not be conducting any interim analysis for PFS. We expect to release the top line PFS data in the early Fall, along with complete and quantitative data at a subsequent scientific meeting. Assuming the PFS result is significant, we plan to file for approval of Genasense in patients with advanced melanoma, on the basis of PFS, combined with various secondary endpoints, and of course, safety. We believe that the demonstration of increased Progression Free Survival not in one, but now two randomized control trials will suffice for worldwide regulatory approval. Our preliminary consultations with regulators in the major European countries have affirmed this strategy. We have formally submitted our intent-to-file notice for the marketing authorization application, or MAA, in Europe, and at their meeting in June the EMEA assigned Spain and France as Rapporteur, co-Rapporteur countries respectively. We note that these were both Rapporteur countries for our prior application, so those reviewers should be very familiar with melanoma as a disease, and our findings in particular. We will undertake similar discussions with the FDA after our primary data become available. We’ve also reported positive news using Genasense combined with an entirely different chemotherapy program. While our Phase III studies have all used Dacarbazine chemotherapy, investigators at NYU have been studying Genasense in combination with temozolomide, which is a derivative of DTIC, or Dacarbazine, and Abraxane for treatment of certain patients with advanced melanoma. At ASCO this past June they reported that this combination was also associated with both high response rates as well as potentially increased survival when compared with the Genasense Dacarbazine program. Thus, as we have anticipated, it appears that Genasense can be successfully combined with and can enhance the activity of a number of other chemotherapy drugs. We have also sought to develop treatment regimens that are easier for physicians and patients, and toward that end we have completed early studies using high dose Genasense given as a one hour IV infusion twice per week. I am pleased to note that this new infusion program is now open to patients with melanoma and we anticipate preliminary efficacy {transcriber note: recording cut out – maybe he said “data to be released”?} in the fall of this year as well.
Tesetaxel
For the other products in our portfolio, we will complete all enrollment later this quarter in the dose ranging study of Tesetaxel given once every three weeks. Tesetaxel is an oral form of the taxane drug class, which is the most widely used class in cancer medicine, including such drugs and well known brands Taxol, Taxotere, and Abraxane. All of these prototype agents are given IV, and most are associated with quite severe side effects including nerve damage if given for prolonged periods. We believe Tesetaxel may avoid many of these serious side effects while retaining high anticancer activity. From a development standpoint, Tesetaxel has now opened a substantial lead over all other competitors. As a consequence we believe that Tesetaxel can be the first oral taxane that receives regulatory approval. The drug has now completed three Phase I and five Phase II studies in more than 275 patients. Distinct anticancer activity has been shown in the Phase II studies of gastric cancer and breast cancer. In our ongoing dose ranging study we ourselves have observed objective responses in patients with nasopharyngeal cancer, GI Stromal Tumors or GISTs, and colorectal cancer. In the final phase of the current study we have converted all final patients to a so-called “flat dose”, specifically to a prescribed single dose of 50mg rather than a weight-based dose, that will also improve patient convenience. We are keenly interested in evaluating at least one alternative schedule for Tesetaxel, in particular the schedule that is once weekly for three weeks. For Taxol, but not for Taxotere, this schedule has proved significantly superior in patients with breast cancer to the once every three week schedule that we have tested to date. Therefore before we begin the expensive and extended studies for registration, we believe its excentral to evaluate this alternative schedule and to prospectively evaluate which of these schedules is going to be therapeutically superior.
Finances
Let me now turn and discuss our current and projected financial circumstances. The last few quarters have proved exceptionally challenging to many small companies. Those that have not been able to secure financing have not survived. In April as Gary pointed out, Genta {transcriber note: taping cut out…} convertible debt transaction, we followed that up in July by closing on the first $3 million dollars of a combined debt and equity raise. As Gary noted we have negotiated with the investors in that round, to increase the size of that round, from $10 million dollars to a total of $13 million dollars. For this improved and additional $10 million dollars in capital, and with that increase, we should have sufficient cash to get into December, and certainly sufficient cash to get the data in our Phase III AGENDA trial. Fundraising this environment has been exceptionally difficult, but we are fortunate in having some exceptional late stage products, whose near term value has been recognized. After a searing string of failures from melanoma patients, we are the next company to report data, and with positive results this fall, Genta stands as the company that may have the first new drug approved for melanoma in more than 40 years. The Genta management team is highly experienced, and has successfully registered a number of oncology products. If our pending trial is positive, we can submit our regulatory applications in less than 9 months. We look forward to seeing you at the upcoming stockholders meeting on August 26, but our next scheduled call with shareholders will be to discuss the AGENDA results with you. We hope you will be all tuning in for what we hope will be very positive news. That concludes my prepared remarks and I’ll be pleased to take any of your questions.