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Gliadel, Alimta and Remodulin....
All 3 were approved after missing primary endpoints.
Timing
ching?
Dang...guess I should shut up until I finish buying...DOH!
THLD finally back to $2....still in believe it or not..eom.
Buckle Seat Belts, IMO.
Timing
DORB... PP in April at .27 ... no bad news since...WAKE UP!!!
FRIDAY, JUNE 30, 2006 4:08 PM
- BusinessWire
>>...Michael Sember, President and Chief Executive Officer of DOR commented, "We are very near the end of our NDA assembly and filing program. The delay is due to the complexity and sheer size of the filing process. We remain highly enthusiastic about orBec(R) and its prospects and we are working diligently to file both the NDA and the MAA as soon as possible. Once filed, the NDA will contain additional information specifically requested by the FDA with regard to survival results in a Phase II study of oral beclomethasone (BDP) and our pivotal Phase III orBec(R) study. We have now added positive survival data in support of oral BDP at 200 days post transplant in the Phase II study, and 1 year post randomization and overall survival post randomization from the pivotal Phase III clinical trial. We believe that the additional new survival data will be an important consideration as the regulatory authorities review this dossier."
When approved, we expect that orBec(R) will be indicated for the treatment of GI GVHD associated with allogeneic bone marrow or stem cell transplant (BMT/SCT) procedures. Based on available statistics we estimate that there are approximately 12,000 such procedures annually in the U.S., and a comparable number in Europe. Estimates as to the annual rate of increase in these procedures vary between 2% and 20%. High rates of morbidity and mortality occur in this patient population. The successful treatment of GI GVHD represents an important unmet medical need. The FDA and EMEA have granted orBec(R) an orphan drug designation. Additionally, the FDA has also made a Fast Track Designation. Once submitted, DOR believes that the orBec(R) NDA should qualify for six month priority review from the date of filing.
BMT/SCT is a very costly procedure and requires an intensive use of healthcare resources. Transplant centers are usually reimbursed at a fixed rate of approximately $250,000 per procedure and this is intended to cover all patient follow-up care. Re-hospitalization of these patients places a significant strain on the financial resources of these hospitals. For example, it is estimated that a single re-admission of these patients can cost the institution between $14,000 and $50,000. Under current standard of care, patients have a high rate of re-admission due to relapse of GI GVHD or leukemia. If patients become terminal and enter critical care, the costs mount quickly. In two separate randomized, double-blinded, placebo-controlled trials in GI GVHD, oral BDP and orBec(R) have shown approximately 55% and 67% reductions in mortality at 200 days post transplant.
http://bigcharts.marketwatch.com/news/articles.asp?guid={394980F9-6B61-4917-80F6-846334D4A8C0}&n....
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Can you say, "Life Saver" ?
Timing
Disclaimers:
1) Actually there is only ONE TRUE "Life Saver", and His name is Jesus Christ.
2) orBec could be a flop. It is even possible that the company will NEVER file the NDA (but highly doubtful, IMO).
3) invest at your own risk. don't buy DORB with money that you can't afford to lose.
Buzz...welcome back...nibble some DORB here IMO. -Mr.T
DORB only a phase I trial? LOL.
February 21, 2006
DOR BioPharma Presents Positive New Survival Findings from Phase II and III Clinical Trials of orBec® at Annual Bone Marrow Transplant Conference.
Abstract Selected for Best Abstracts Award .
Miami, FL, February 21, 2006 — DOR BioPharma, Inc. (AMEX: DOR) ("DOR", or the "Company") announced today that survival results for orBec® (or oral beclomethasone dipropionate) from two randomized, double-blinded, placebo-controlled clinical trials for the treatment of patients with gastrointestinal Graft-versus-Host disease (iGVHD), were presented by George B. McDonald, MD, inventor of orBec®, at the annual Tandem Bone Marrow Transplant Meeting of the American Society for Blood and Marrow Transplantation and the International Bone Marrow Transplant Registry in Honolulu on February 18, 2006 in a presentation entitled "Oral beclomethasone dipropionate for gastrointestinal GVHD: a corticosteroid-sparing treatment with improved survival at day-200." An abstract of this presentation has been published (Biology of Blood and Marrow Transplantation 2006; 12 (Supplement 1): 1-2). The abstract was chosen to receive a Best Abstracts Award at the conference.
The survival data, collected by DOR in response to a specific FDA request as part of its process to submit a New Drug Application ("NDA"), included a comparison of the statistically significant survival benefit demonstrated in favor of orBec® in its pivotal Phase III clinical trial to survival among 60 patients previously studied in a randomized, double-blinded, placebo-controlled, Phase II clinical trial of oral beclomethasone dipropionate for iGVHD. The Phase II clinical trial was conducted at the Fred Hutchinson Cancer Research Center in Seattle, as described in a publication in the journal Gastroenterology. The Phase II clinical trial was similar in design to the pivotal Phase III trial which was completed in late 2004. In the Phase II study, patients with iGVHD were randomized to receive an induction course of conventional prednisone therapy plus either oral beclomethasone dipropionate or placebo. The treatment response at study day-30 was 22 of 31 (71%) vs. 12 of 29 (41%) in the oral beclomethasone and placebo groups, respectively, achieving a statistically significant p-value of 0.02.
The new survival analysis of patients enrolled in this earlier Phase II trial suggests that results were similar to those from the pivotal Phase III multi-center study. In the Phase II trial, there were reductions in the risk of mortality of 55% and 43% at transplant day-200 and one year post-randomization among patients randomized to oral beclomethasone dipropionate, respectively. The comparable survival data from the 129-patient Phase III pivotal trial were 66% and 51% reductions in the risk of mortality at transplant day-200 and one-year post-randomization among patients randomized to orBec®, respectively. In the Phase III pivotal trial, a subgroup analysis revealed that among patients who had received stem cells from unrelated donors, the reduction in the risk of day-200 mortality among patients randomized to orBec® was 94%.
"We believe that these Phase II results significantly strengthen our case that the robust mortality result that we saw in the Phase III pivotal trial was due to the positive effect of orBec®," said Michael T. Sember, President and Chief Executive Officer of DOR. "We have estimated that there is a 1 in 5,000 chance of observing similar odds ratios in the Phase II and Phase III studies if there was no effect of orBec® on day-200 survival. Consequently, we believe that since the mortality results from both clinical trials are so similar, this strongly suggests the hazard of mortality for patients randomized to orBec® was lower than placebo."
George B. McDonald, MD, Head of the Gastroenterology/Hepatology Section at the Fred Hutchinson Cancer Research Center, inventor of orBec® and a consultant to DOR, stated, "Based on all the data we have collected, I believe that orBec® represents the first new therapy for iGVHD that significantly improves survival with no discernable side effects. iGVHD is the most significant and life threatening toxicity associated with allogeneic hematopoietic cell transplants. The fact that two randomized trials show similar reductions in the hazard of mortality at one year post-randomization suggests that use of orBec® will impact outcomes in the majority of patients undergoing allogeneic transplant—particularly in recipients of unrelated donor stem cells, in whom reductions in mortality were highly significant. Over the past 30 years, there has not been a new drug approved that reduces mortality in any form of Graft-versus-Host Disease. orBec®'s topical activity in the gastrointestinal tract results in better survival in patients with intestinal GVHD, probably due to preservation of the intestinal mucosal barrier and the avoidance of prolonged immune suppression with prednisone, resulting in fewer fatal infections."
About Intestinal Graft-versus-Host Disease (iGVHD)
iGVHD is a life threatening condition that is one of the most common causes for the failure of bone marrow transplant procedures. These procedures are being increasingly utilized to treat leukemia and other cancer patients with the prospect of eliminating residual disease and reducing the likelihood of relapse. orBec® represents a first-of-its-kind oral, locally acting therapy tailored to treat the gastrointestinal manifestation of GVHD, the organ system where GVHD is most frequently encountered and highly problematic. orBec® is intended to reduce the need for systemic immunosuppressives to treat iGVHD. Currently approved systemic immunosuppressives utilized to control iGVHD substantially inhibit the highly desirable graft-versus-leukemia (GVL) effect of bone marrow transplants, leading to high rates of aggressive forms of relapse, as well as substantial rates of mortality due to opportunistic infection.
About DOR BioPharma, Inc.
DDOR BioPharma, Inc. is a biopharmaceutical company addressing life-threatening side effects of cancer and cancer treatments, serious gastrointestinal diseases and disorders, and biomedical countermeasures. Our lead product, orBec® (oral beclomethasone dipropionate), is a potent, locally-acting corticosteroid being developed for the treatment of intestinal Graft-versus-Host disease (iGVHD), a common serious complication of bone marrow transplantation for cancer, as well as other GI disorders characterized by severe inflammation. We plan to file a new drug application (NDA) with the FDA for orBec® for the treatment of iGVHD in the first quarter of 2006.
Through our BioDefense Division, we are developing biomedical countermeasures pursuant to the paradigm established by the recently enacted Project BioShield Act of 2004. Our biodefense products in development are bioengineered vaccines designed to protect against the deadly effects of ricin toxin and botulinum toxin, both of which are considered serious bioterrorism threats. Our ricin toxin vaccine, RiVaxTM, has completed the clinical portion of its Phase I clinical trial in normal volunteers. We have also announced the initiation of a new botulinum toxin therapeutic development program based on rational drug design.
For further information regarding DOR BioPharma, please visit the Company's website located at www.dorbiopharma.com.
This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, that reflect DOR BioPharma's current expectations about its future results, performance, prospects and opportunities, including statements regarding the potential use of orBec® for the treatment of iGVHD and the prospects for regulatory filings for orBec®. Where possible, DOR BioPharma has tried to identify these forward-looking statements by using words such as "anticipates", "believes", "intends", or similar expressions. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. DOR BioPharma cannot assure you that it will be able to successfully develop or commercialize products based on its technology, including orBec®, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats, manufacturing and conducting preclinical and clinical trials of vaccines, and obtaining regulatory approvals, that its technologies will prove to be safe and effective, that its cash expenditures will not exceed projected levels, that it will be able to obtain future financing or funds when needed, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further grants and awards, maintain its existing grants which are subject to performance, enter into any biodefense procurement contracts with the U.S. Government or other countries, that it will be able to patent, register or protect its technology from challenge and products from competition or maintain or expand its license agreements with its current licensors, that it will be able to maintain its listing on the American Stock Exchange ("AMEX") by completing a transaction which will provide it with shareholders' equity of at least $6 million, or that its business strategy will be successful. Important factors which may affect the future use of orBec® for iGVHD include the risks that: because orBec® did not achieve statistical significance in its primary endpoint in the pivotal Phase III clinical study (i.e. a p-value of less than or equal to 0.05), the FDA may not consider orBec® approvable based upon existing studies, orBec® may not show therapeutic effect or an acceptable safety profile in future clinical trials, if required, or could take a significantly longer time to gain regulatory approval than DOR BioPharma expects or may never gain approval; DOR BioPharma is dependent on the expertise, effort, priorities and contractual obligations of third parties in the clinical trials, manufacturing, marketing, sales and distribution of its products; or orBec® may not gain market acceptance; and others may develop technologies or products superior to orBec®. DOR BioPharma presently is involved in financing negotiations which could result in the issuance of a significant number of shares of its equity securities, thereby diluting the equity interests of present stockholders. These and other factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, DOR BioPharma's most recent reports on Form 10-QSB and Form 10-KSB. DOR BioPharma assumes no obligation to update or revise any forward-looking statements as a result of new information, future events, and changes in circumstances or for any other reason.
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No brainer under $.30... Watch!
Timing
A little more DD on DORB...
The did a PP in April....13million shares at $.275 and 13 million warrants exercisable for 3 years at $.45
>>As of May 24, 2006, there were 68,463,997 shares outstanding, including the 16,168,147 shares of our common stock offered by the Selling Stockholders pursuant to this prospectus.<< (that does not include the 13 million warrants at $.45)
http://secfilings.nasdaq.com/filingFrameset.asp?FileName=0000812796%2D06%2D000038%2Etxt&FilePath...
>>When approved, we expect that orBec® will be indicated for the treatment of GI GVHD associated with allogeneic bone marrow or stem cell transplant (BMT/SCT) procedures. Based on available statistics we estimate that there are approximately 12,000 such procedures annually in the U.S., and a comparable number in Europe. Estimates as to the annual rate of increase in these procedures vary between 2% and 20%. High rates of morbidity and mortality occur in this patient population. The successful treatment of GI GVHD represents an important unmet medical need. The FDA and EMEA have granted orBec® an orphan drug designation. Additionally, the FDA has also made a Fast Track Designation. Once submitted, DOR believes that the orBec® NDA should qualify for six month priority review from the date of filing. << (12,000 is not many, but since there is a high rate of morbidity, most of them might take the drug.)
http://www.dorbiopharma.com/press/2006/2006JUN30.htm
The following is a scientific explanation of the disease from google (no connection to company in this study):
Acute upper gastrointestinal graft-versus-host disease: clinical significance and response to immunosuppressive th
Insiders: http://finance.yahoo.com/q/it?s=DORB.OB
I have orders in at .26
Timing
Been loading DORB today....
http://finance.yahoo.com/q?s=dorb.ob
"We are now in the final stages of the assembly and filing of our NDA for orBec® which is expected by the end of this month (AUGUST)," stated Michael Sember, President and Chief Executive Officer of DOR.
http://biz.yahoo.com/bw/060814/20060814005932.html?.v=1
NDA filing this month? That means they are DONE with all trials for this drug....granted, not huge drug, but definately worth a rally IMO.
The stock was delisted from AMEX in April....probably one reason why it is hated today.
http://biz.yahoo.com/e/060420/dorb.ob8-k.html
Debt is teensy weensy- $3.2Mn... 50-70 cent stock on NDA filing....$1.50 - $2.50 if approved, imo.
http://www.dorbiopharma.com/index.html
THLD...finally! Holding actually. Timing.
fwiw...Tang still loading THLD...over 10% so far....
http://secfilings.nasdaq.com/filingFrameset.asp?FileName=0001104659%2D06%2D055853%2Etxt&FilePath...
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Are the bears leaving?
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AAGH could go to point 4. eom
Just got back from long weekend...AAGH...Weeeeeeeee! eom
A couple good Shorts...
http://www.funlol.com/funpages/dancing-midgets.html
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quite pleased with THLD report...
Gobs of cash (about 2 years worth) and significant milestones this year.
Hold it. Buy if it falls.
Timing
PXT short interest a/o Jul.14 4,514,956 DtC: 16.27 eom
Up to 4k of Raw's PXT...
No hurricanes between now and next Tues. = CHING, imo.
http://finance.yahoo.com/q/bc?s=PXT&t=1y
me thinks all the bad news is out...not a lot of holders eager to dump this dog.
Timing
Man its HOT outside today..ching for HDSN...LOL. Timing
Don't chase it though...wait for retrace IMO. Timing
THLD..up 6% on 200k? Imagine when 2Mn shorts start covering.
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Don't forget to get some THLD. eom.
Finally bought HDSN. eom
swamp...
You get any THLD yet? Looks like your type of stock if I recall.
Timing
Incredible story about an elephant's memory
UPI July 3, 2006
A young man was on holiday in Kenya after graduating from college. While he was walking through the bush, he came across a young bull elephant standing with one leg raised in the air. The elephant seemed distressed so the man approached it very carefully. He got down on one knee and inspected the elephant's foot. There was a large thorn deeply embedded in the bottom of the foot.
As carefully and as gently as he could he worked the thorn out with his hunting knife, after which the elephant gingerly put down its foot. The elephant turned to face the man and with a rather stern look on its face, stared at him. For a good ten minutes the man stood frozen thinking of nothing else but being trampled. Eventually the elephant trumpeted loudly, turned and walked away. The man never forgot that elephant or the events of that day.
Twenty years later the man was walking through the zoo with his teenaged son. As they approached the elephant enclosure, one of the creatures turned and walked over to where they are standing at the rail. The large bull elephant stared at him and lifted its front foot off the ground, then put it down. The elephant did that several times, all the while staring at the man. The man couldn't help wondering if this was the same elephant.
After a while it trumpeted loudly; then it continued to stare at him. The man summoned up his courage, climbed over the railing and made his way into the enclosure. He walked right up to the elephant and stared back in wonder. Suddenly the elephant trumpeted again, wrapped its trunk around one of the man's legs and swung him wildly back and forth along the railing, killing him.
Probably wasn't the same elephant.
True or false I don't know, but funny I know!
Timing
*Yawn*...wake me up when things get exciting. Timing
fhal TANKING...surprised it wasn't halted. eom
Brave.
FWIW re: THLD.....
Kevin C. Tang of Tang Capital Management bought 2,150,000 shares of THLD on the 17th, or 5.77% of the company. From what I here he is a biotech guru...just google him and you will see.
http://secfilings.nasdaq.com/filingFrameset.asp?FileName=0001104659%2D06%2D049301%2Etxt&FilePath...
Timing
Timing is pounding the table...
THLD!!!!
Get a little and hold it for a couple weeks..add dips.
R.W.Baird Focus On Oncology Healthcare Conference
Wednesday, August 2, 2006
9:35 AM ET
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Timing baby! eom.
Hogsgeteaten...
Since I just posted that I am wondering why I only have about 30% of my liquid assetts in THLD. I think I will make it more like 50-60% tomorrow.
Timing
hogsgeteaten...
nothing has chaged...here is the last sentence from your post:
>>"We will continue to seek additional product candidates with which to broaden our portfolio and look forward to the results from our ongoing Phase 2 and Phase 3 trials of Glufosfamide for the treatment of pancreatic cancer by year-end."<<
TH-070 is done for. But Glufosfamide is a completely different program and is actually further along than TH-070 was. It has fast track status and, as I said before, is projected to have $200,000,000 in annual sales. That for what is currently a $60Mn dollar company that has $80Mn in cash and TOTAL LIABILITIES OF $12 MILLION? Puleeeeeez! In other words, the market is saying that their most advanced drug is worth nothing? Hmmmmmmm!
Timing
It's official.
I have been considering THLD more and more.
Decided to load heavy.
THLD is not the only stock I own.
A dime to the underside is about as much risk as I see in near-term.
Up-side potential huge.
>>The American Cancer Society estimates that 32,180 patients were diagnosed with pancreatic cancer in the United States in 2005, and approximately 31,800 patients would die from the disease.<<
If half of those took the drug at an estimated $1000 per month, you're looking at almost a $200,000,000 drug, and it was just cleared to finish phase 3 trials:
http://biz.yahoo.com/prnews/060601/sfth088.html?.v=45
http://bigcharts.marketwatch.com/quickchart/quickchart.asp?symb=thld&sid=0&o_symb=thld&f...
If you are buying any stocks right now, THLD should be one of them, imo.
Timing
THLD info...
http://finance.yahoo.com/q/bc?s=THLD&t=3m
Their most advanced drug, in phase 3 trials was not affected at all during this crisis, and is said to be a $200mil drug
2 mill shares short and 2 bux cash
$2 by next week imo.
$5 by year end imo.
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THLD ready to run IMO. Timing
GoingUp...you in? Moon shoot!
If the company actually makes it into phase 3 trials....
BOOM! $.30 imo.
Timing
To da moooooooon! eom