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Good article on Accentia/BioVest
http://www.biopharmaceuticalnews.blogspot.com/
Roth Capital & 09/30 Extension
another delay, gee another suprise extension
Biovest International product gets orphan drug status from FDA
http://www.bizjournals.com/stlouis/othercities/tampabay/stories/2010/07/26/daily2.html
Adam Feuerstein at it again and thestreet.com. As we have known and seen this A.F. has an agenda, to flop the stock. I prefer the the writings of James Hill MD, @ gene.md a share holder with an extreme education.
I'm long and still holding since my accumlation.
http://gene.md/2010/05/20/biovest-meets-... Due Dilegence is the name of the game
From thestreet.com and comments by chance56
" http://www.thestreet.com/storycomments/10813622/1/biotech-stock-mailbag-ziopharm.html
Please visit Dr. James Hill's explanation of why the 3 month production time is not the partnership hindrance that Adam has portrayed it to be...
http://seekingalpha.com/article/206258-biovest-meets-skeptic-s-requirements-for-the-next-dendreon-part-1
This is one in a four part series that specifically addresses many of the misrepresentations of BiovaxID's potential. All four parts can be viewed on Seeking Alpha or http://gene.md/
There is a great deal of misunderstanding in regards to BiovaxID's data and the financial status of both Biovest and Accentia. Read Hill's articles, read though the court docs (settlement agreement with Laurus, plans of reorganization and disclosure statements), look at existing blood cancer treatments and also FDA regulatory precendents before taking full acceptance of Adam's opinion on this one.
By chance56 on 7/22/10 12:49 PM"
Disclosure Statements its gonna pop......
DS for emergence,
http://www.srbp.com/accentia/accentia.htm
http://www.srbp.com/biovest/biovest.htm
from Yahoo board by mc_m98
Bankruptcy fails to derail biotech opportunists Accentia, Biovest
Read more: Bankruptcy fails to derail biotech opportunists Accentia, Biovest - Tampa Bay Business Journal
http://tampabay.bizjournals.com/tampabay/stories/2010/07/19/story6.html
"New Cancer Vaccine Kills Lymphoma, Now in Phase III Clinical Trials"
July 17th, 2010 by Drew Halley
http://singularityhub.com/2010/07/17/new...
From the Accentia Yahoo mb:
I agree, I think we will test 1.20 again before Aug 9th date. MM's are really squezzing the faint of heart. The old portfolio looked really good when we were pushing 2.00. now it looks rather depressing. Long in at .55 so I have ways to go before I run.
Biovest's Stock Listing Upgraded to OTCQB(TM) Market
http://www.foxbusiness.com/story/markets/industries/health-care/biovests-stock-listing-upgraded-otcqbtm-market/
Order Scheduling Hearing on Disclosure Statement
Hearing scheduled for 8/9/2010 at 01:30 PM at Tampa, FL
emergence is in view
Extention till Aug for lagard creditors.
looking for emergence July 2010
Disclosure Statement - Joint Disclosure Statement for Joint Plan of Reorganization of Biovest International, Inc., Biovax, Inc., AutovaxID, Inc.,
Biolender, LLC, and Biolender II, LLC under Chapter 11 of Title 11, United
States Code Filed by Charles A. Postler on behalf of Debtors AutovaxID, Inc.,
Biolender II, Inc., Biolender, LLC, Biovax, Inc., Biovest International, Inc..
(Postler, Charles) (Entered: 07/02/2010)
in preparation for emergence from BK.
available @ netdocs or thru Accentia Biopharmaceuticals Forum on Yahoo.
I am long on both companies, and I believe them both to be headed in the right direction. Hopefully this is simply profit being taken off the table while offering others a great entry point into 2 stocks that could take off within the next few months.
It seems to have the stench of a bear raid...
What is going on today with Accentia and Biovest????? I can't find any news to save my life that would justify this ridiculous drop. Anyone know anything?
Not sure; at least they were at one time. The news links they reference are old. However, BVTI's senior creditor is Laurus, with whom they just agreed to new terms and this was part of the reorg plan filed with the bankruptcy court recently.
Accentia and Biovest should emerge from bankruptcy soon. Hopefully, they will have a run like Dendreon.
Are these guys still involved,
http://www.hopkinscap.com/index.php
just doing dd after reading about another one of their companies
http://seekingalpha.com/article/204752-biodelivery-sciences-international-why-i-believe-patience-will-reward-investors
I think in the short - medium term the better play is BVTI. When it files the BLA and when(if) the FDA approves the headlines will reference BVTI first and foremost. Although, the gap in pps between the two may narrow over the next 3 months.
ABPIQ may be better long term. We shall see.
agreed. tons of crap in sewage land...lots of potential here...give it time, people will be hoarding here, and buyers at these levels and lower will gladly sell then
It is interesting how dog shit stocks with limited potential can attract a huge following on these message boards, yet a quality company ( like BVTI ) with massive potential and regular public reporting barely gets anyone excited. Strange.
Great news!!! Initial $1.5 mil contract with DOD. The AutovaxId bioreactor provides opportunities for revenues independent of the lymphoma vaccine. The military, universities, WHO, and other companies trying to develope different vaccines. Looks like a very profitable business model.
With the recent DNDN approval there was a story( I will find the link) that mentioned BVTI at teh bottom of the article. With the orphan drug status with eh FDA and now the approval of DNDN, BVTI could just be a home-run.
Here it is.
next DNDN must read pipeline and chart:
Devil in the Details
Provenge Nod Bodes Well, but No Free Pass for Cancer Vaccines
Published: May 3, 2010
By Trista Morrison
Staff Writer
Dendreon Corp. made history last week by securing approval for Provenge (sipuleucel-T), the first therapeutic cancer vaccine ever cleared by the FDA.
The news - and Dendreon's announcement of higher-than-expected pricing - boosted the Seattle-based biotech's stock 27 percent on Thursday and another 8 percent on Friday, capping a run-up of more than 1,800 percent in just over a year. Shares (NASDAQ:DNDN) closed Friday at 54.06, up $3.88. (See BioWorld Today, April 30, 2010.)
And Dendreon wasn't the only one to gain. Cancer vaccine companies basking in the reflected glow included AVAX Technologies Inc., ImmunoCellular Therapeutics Ltd., Biovest International Inc., Antigenics Inc., Celldex Therapeutics Inc., Oncothyreon Inc., Vical Inc., Cel-Sci Corp., Northwest Biotherapeutics Inc. and others - some of which saw their shares rocket up nearly 50 percent Thursday.
But what does Provenge's approval actually mean for all of those companies?
On the one hand, it proves that a therapeutic vaccine can work in cancer and establishes a regulatory precedent. Jeffrey Abbey, president and CEO of Argos Therapeutics Inc., said the approval "validates the field," and he predicted many companies in the space may benefit from the increased attention.
It certainly has been a long time coming.
The idea of using a vaccine to harness the immune system and fight cancer has captivated scientists since the early 1900s, but putting the theory into practice proved no easy task. Among the biotechs to face failure in late-stage trials were Antigenics Inc., CancerVax Corp., Cell Genesys Inc., Favrille Inc., Genitope Corp., Progenics Pharmaceuticals
Inc., Therion Biologics Corp. and many more. Even Dendreon missed the primary endpoint in its first two Phase III trials. The situation got so bad that the entire field re-branded itself as "active immunotherapy" because the term "cancer vaccine" had become unpalatable to both investors and partners.
The importance of Dendreon's win with Provenge cannot be overstated. President and CEO Mitchell Gold certainly was warranted in using phrases like "the dawn of an entirely new era in medicine" and "the Holy Grail of oncology."
But at the same time, Vical Inc. president and CEO Vijay Samant noted that "just because Provenge got approval doesn't mean everyone is going to get a free ride."
The fact is, while cancer vaccines get lumped into a single category, they involve a variety of technologies that are often more different than similar. And those that have failed have done so for very different reasons.
Sometimes it comes down to vaccine design. Some experts favor the autologous (personalized) approach like Provenge, while others prefer an allogeneic (off-the-shelf) product. And almost every vaccine in the clinic has its own mechanism, be it single-antigen, multiple-antigen, DNA, RNAi, whole cell, dendritic cell or something else entirely.
The choice of tumor also can impact the success or failure of a program: Patients with aggressive cancers might not live long enough to show an immune response. Trial design is important, too, and trials differ in their use of adjuvants, their administration schedule, their endpoints, their use of concomitant treatments and other factors.
All of which indicates that while Dendreon's Provenge approval is indeed a success for the entire cancer vaccine field, it is no guarantee of individual success for anyone else.
There are some, however, who may be more entitled to ride Dendreon's coattails. Argos is in a Phase IIa kidney cancer trial with cancer vaccine AGS-003, which is somewhat similar to Provenge in that it is personalized and uses dendritic cells. But CEO Abbey said that Argos has built on Dendreon's approach by using only dendritic cells rather than an antigen-presenting cell mixture. Additionally, while Dendreon uses personalized cells with an off-the-shelf antigen, Argos uses personalized cells and RNAi extracted from each patient's tumor.
Vical's Allovectin-7, on the other hand, is an off-the-shelf plasmid/lipid complex containing the DNA sequences encoding HLA-B7 and beta-2 microglobulin, which Samant explained is designed to teach the immune system to recognize all of the antigens associated with the tumor. The approach has similarities to Merial Ltd.'s Oncept, which was approved earlier this year for melanoma in dogs.
Data from Vical's Phase III trial of Allovectin-7 are expected in the second half of 2011.
Other cancer vaccines in late-stage development include AVAX's MVax for melanoma, Bioniche Life Sciences Inc.'s Urocidin for bladder cancer, Oncothyreon and Merck KGaA's Stimuvax for lung and breast cancer, GlaxoSmithKline plc's MAGE-A3 for lung cancer, Apthera Inc.'s NeuVax for breast cancer, Transgene SA's TG4010 for lung cancer, Celldex Therapeutics Inc.'s CDX-110 for glioblastoma and GlobeImmune Inc.'s GI-4000 for pancreatic cancer.
Biovest Announces Upcoming Conference Calendar to Present on Personalized Cancer Vaccine Targeting B-cell Lymphomas
(ABPIQ) Accentia Biopharmaceuticals:
12:19p ET March 17, 2010 (Business Wire)
Biovest International, Inc. (Other OTC:BVTI) today announced that the company is confirmed to present its personalized cancer vaccine, BiovaxID(R), at the following upcoming conferences:
-- World Vaccine Congress 2010, April 19-22, Washington D.C.
-- BIO International Convention, May 3-6, Chicago
-- Active Immunotherapeutics Forum 2010, June 21-23, Barcelona, Spain
At these events, Biovest plans to review positive Phase II and Phase III data for BiovaxID and discuss the potential market opportunity including regulatory and manufacturing strategies. The company will make further announcements related to the specifics for each presentation prior to each conference.
In addition, Biovest will be attending the American Society of Oncology's (ASCO) Annual Meeting, June 4-8 in Chicago, intending to meet with corporate partnering candidates, key opinion leaders treating lymphomas and patient advocacy groups.
Biovest's President, Mr. Samuel S. Duffey, stated, "As Biovest and its parent, Accentia Biopharmaceuticals, Inc., prepare to exit from reorganization, it is a priority for us to attend and present at key industry and investor events to communicate the vital role that we envision for BiovaxID in potentially enhancing existing regimens for the treatment of indolent follicular non-Hodgkin's lymphoma and other B-cell blood cancers."
About Biovest International, Inc.
Biovest International, Inc. is an emerging leader in the field of personalized immunotherapies targeting life-threatening cancers of the blood system. Developed in collaboration with the National Cancer Institute, BiovaxID(R) is a patient-specific, anti-lymphoma cancer vaccine, demonstrating statistically significant Phase III clinical benefit by prolonging disease-free survival in patients suffering from indolent follicular non-Hodgkin's lymphoma. BiovaxID has been granted Orphan Drug Designation by both the U.S. FDA and the European EMEA. Biovest has also developed and markets a proprietary line of automated hollow fiber bioreactor systems, including the innovative AutovaxID(TM) which is a production platform for the scalable manufacture of difficult-to-produce biologics including personalized medicines, monoclonal antibodies, cell culture vaccines and therapeutics targeting highly infectious agents. Since 1981, Biovest has been offering its clients a wide range of instrumentation and cell culture contract manufacturing services. Headquartered in Tampa, Florida with its bio-manufacturing facility based in Minneapolis, Minnesota, Biovest is publicly-traded on the Over-the-Counter (OTC) market with the stock-ticker symbol "BVTI", and is a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (Other OTC:ABPIQ).
For further information, please visit: http://www.biovest.com
Forward-Looking Statements: Statements in this release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to statements about BiovaxID(R), AutovaxID(TM), events occurring after dates hereof, and any other statements relating to products, product candidates, product development programs, the FDA or clinical study process including the commencement, process, or completion of clinical trials or the regulatory process. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, expectations and intentions, and other statements identified by words such as "may," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause the actual results of Biovest to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors include, but are not limited to, risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval for product candidates; competition from other pharmaceutical or biotechnology companies; and the additional risks discussed in filings with the Securities and Exchange Commission. All forward-looking statements are qualified in their entirety by this cautionary statement, and Biovest undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. The product names used in this statement are for identification purposes only. All trademarks and registered trademarks are the property of their respective owners.
SOURCE: Biovest International, Inc.
Biovest International, Inc.
Corporate Contact:
Douglas Calder, Director of Investor Relations & Public Relations
813-864-2558
dwcalder@biovest.com
http://www.shortsqueeze.com/?symbol=bvti
Biovest Intl Inc $ 1.70
BVTI 0.15
Short Interest (Shares Short) 132,500
Days To Cover (Short Interest Ratio) 1.2
Short Percent of Float 0.92 %
Short Interest - Prior 82,300
Short % Increase / Decrease 61.00 %
Short Squeeze Ranking™ 6
% From 52-Wk High ($ 2.11 ) -24.12 %
% From 52-Wk Low ($ 0.11 ) 93.53 %
% From 200-Day MA ($ 0.70 ) 58.82 %
% From 50-Day MA ($ 1.45 ) 14.71 %
Price % Change (52-Week) 532.70 %
Shares Float 14,328,740
Total Shares Outstanding 96,451,503
% Owned by Insiders 85.10 %
% Owned by Institutions %
Market Cap. $ 163,967,555
Trading Volume - Today 202,303
Trading Volume - Average 109,000
Trading Volume - Today vs. Average 185.60 %
Earnings Per Share -0.16
PE Ratio
Record Date 2010-AprB
Sector
Industry
Exchange NBB
8K filing 4/26/2010
http://ih.advfn.com/p.php?pid=nmona&article=42536631&symbol=NO%5EBVTI
Biovest Announces Settlement with Largest Creditor
Biovest International, Inc. (Other OTC: BVTI) today announced that the Company and its largest creditor, Laurus Master Fund, Ltd., including Laurus’ affiliates and assignees, have reached a settlement to restructure the Company’s debt and address the business issues described below, representing a major step toward Biovest filing a Plan of Reorganization to emerge from Chapter 11. As required by the settlement, Biovest filed a motion seeking approval of the settlement terms with the U.S. Bankruptcy Court, Middle District of Florida.
Select key elements of the settlement with Laurus are as follows:
Restructure approximately $30.2 million of pre-petition indebtedness, consisting primarily of short-term obligations, into two notes aggregating to $29.1 million with the commencement of scheduled payments of principal and interest deferred until two years after Biovest emerges from Chapter 11
Reduce royalties to Laurus and other parties based on sales of Biovest’s personalized cancer vaccine, BiovaxID®, from 35.0% to 6.25%
Eliminate all royalties based on the sales of Biovest’s automated bio-manufacturing system for personalized medicines and cell-based products, AutovaxID™, including the remaining $7.5 million balance of a previously guaranteed minimum royalty payment
Cancel all warrants issued to Laurus, including approximately 23.4 million warrants to purchase Biovest common shares at an exercise price of $0.01 per share
Laurus will receive a 9.99% equity stake in Biovest, subject to resale restrictions and will support and vote for acceptance for Biovest’s Plan of Reorganization
Biovest’s President, Mr. Samuel S. Duffey, stated, “This settlement represents an extremely positive development for Biovest, and I am appreciative that Laurus, as our largest senior secured creditor, has placed such a strong vote of confidence in the Company and its management. With this settlement, we have restructured the significant business arrangements necessary to pave the way for the commercialization and licensing potential of BiovaxID. Additionally, by delaying for two years all principal and interest payments, this settlement significantly enhances our financial position and supports our goal of obtaining marketing approval for BiovaxID.”
In other news, Biovest announced that BiovaxID has been highlighted as a promising new lymphoma vaccine therapy in articles recently published in Cure Magazine and Coping with Cancer Magazine. In order to access these articles, please visit the links below:
Cure Magazine, “Getting Personal” by Katy Human: http://www.curetoday.com/
Coping with Cancer Magazine, “Emerging Therapies in Non-Hodgkin Lymphoma”: http://copingmag.com/cwc/index.php/cancerType/lymphoma/
About Biovest International, Inc.
Biovest International, Inc. is an emerging leader in the field of personalized immunotherapies targeting life-threatening cancers of the blood system. Developed in collaboration with the National Cancer Institute, BiovaxID® is a patient-specific, anti-lymphoma cancer vaccine, demonstrating statistically significant Phase III clinical benefit by prolonging disease-free survival in patients suffering from indolent follicular non-Hodgkin’s lymphoma. BiovaxID has been granted Orphan Drug Designation by both the U.S. FDA and the European EMEA. Biovest has also developed and markets a proprietary line of automated hollow fiber bioreactor systems, including the innovative AutovaxID™ which is a production platform for the scalable manufacture of difficult-to-produce biologics including personalized medicines, monoclonal antibodies, cell culture vaccines and therapeutics targeting highly infectious agents. Since 1981, Biovest has been offering its clients a wide range of instrumentation and cell culture contract manufacturing services. Headquartered in Tampa, Florida with its bio-manufacturing facility based in Minneapolis, Minnesota, Biovest is publicly-traded on the Over-the-Counter (OTC) market with the stock-ticker symbol “BVTI”, and is a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (Other OTC: ABPIQ).
For further information, please visit: http://www.biovest.com
Recent Biovest Intl BVTI News
Date Time Headline More BVTI news
04/26/2010 4:47PM Current report filing (8-K)
04/20/2010 6:45AM Biovest to Present at World Vaccine Congress 2010
04/19/2010 8:53AM Current report filing (8-K)
04/19/2010 6:45AM Biovest Announces Settlement with Largest Creditor
03/23/2010 5:04PM Current report filing (8-K)
03/17/2010 12:19PM Biovest Announces Upcoming Conference Calendar to Present on Personalized Cancer Vaccine Targeting B-cell Lymphomas
link to open and read news:
http://ih.advfn.com/p.php?pid=squote&symbol=NO%5eBVTI
Posted by: klinkoo Date: Tuesday, March 09, 2010 9:42:36 PM
In reply to: RunnersDad who wrote msg# 159 Post # of 183
we are not at all that far, BLA for BiovaxID will be submitted in June this year for a fast approval before end of 2010. out of BK with a great improved balance sheet, shares intact, hopefully no dilution or very light and a major contract for AutovaxID in Q1 2010, and do you think this is a price manipulation?? this is going to 3$ with no time and 5$ before june.
yes..this chart looks promising, even the subsidiary stock that owns...
an overview of other immunotherapy companies out there that i am following. i really like ADXS, IMUC, and DVAX.
http://chasingthealpha.blogspot.com/2010/04/immunotherapeutics-what-dndns-provenge.html
( ad clicks appreciated )
This keeps rising. Something might be brewing for a PR on the up listing.
BLA approval is very likely, given the facts that it is approved on a "named patient" basis in Europe and the FDA granted "Orphan Drug status". However, you never know for sure until it is a done deal.
Check out Dendreon DNDN. They are in the same vaccine space but for prostate cancer. IIRC, about a year ago they were at 2.50 and now they trade around $35.00.
The first step is emerging from bankruptcy. That should happen by June and it may be eminent. As soon as they are out of bankruptcy re-org the stock will really move.
Thanks. I am really going to be doing more DD in June/July.
What is your feeling with the BLA approval?
They expect to file the "BLA" by the end of June. From there it may take another 3 - 6 months for approval.
I find this company very interesting with excellent potential. what is the FDA time line? can you put the in the ibox?
put this in the search engine:
BIOVEST & ACCENTIA : BROTHER & SISTER BIOTECHS TO EXIT BANKRUPTCY
Exactly !!!! 10.00 will look cheap in about five months.
No we will spike on the reorg. news!! we are looking at $5-10 on that news. which will come out by the end of the month according to the CEO... than a slow steady climb until they submit the BLA, than another spike to the high 20s on approval. imo
Does anyone think that this is officially the beginning of the long slow run up to huge gains? Or do you think that it is going to hover between a 1.50 and 2.00 until they officially submit BiovaxID for FDA approval?
Anymore prognosticatons ????
The FDA approval by the end of this year will determine the future pps. If approved this will run well over 10.00 if not then it will tank. This is not your average OTC:BB stock. They were a Nasdaq ( parent co) company before reorg.
We should see 1.50 today.
It is called profit taking. This PPS was in the .30's a few months ago. When they announce they are out of bankruptcy reorg. this will run again. Then more profit taking and then a steady rise to 10.00. Just like Dendreon. Last year they were 2.50 now 35.00.
This stock has run up so much in a short period of time . Just a little consolidation. This will go back up.
Why the sell off ?
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http://www.biovest.com
Biovest International Inc, is a majority-owned subsidiary of Accentia Biopharmaceuticals Inc., a vertically-integrated specialty biopharmaceutical company with services to commercialize targeted therapeutics. Accentia is a publicly traded company (NASDAQ: ABPI) that has a product portfolio featuring targeted therapeutics, specialty sales and marketing, pharmacoeconomic services, product development, and specialty distribution.
Biovest has a deep foundation in the manufacture of biological drugs from small research scale quantities to large volumes for Phase I and Phase II clinical material. In addition, Biovest International develops, manufactures, and markets patented cell culture systems and equipment to pharmaceutical, diagnostic and biotechnology companies, as well as leading research institutions worldwide. For over 10 years the company has operated the National Cell Culture Center (NCCC) under a grant from the National Institutes of Health.
Biovest is the holder of a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute for the commercialization of BiovaxID, a personalized biologic therapeutic cancer vaccine for the treatment of non-Hodgkin's lymphoma. This therapy, referred to as BiovaxID, is currently in a phase 3 pivotal trial at 24 major medical institutions in the US.
SEC FILINGS
http://phx.corporate-ir.net/phoenix.zhtml?c=154286&p=irol-sec
RECENT NEWS
http://finance.yahoo.com/q?s=BVTI.OB
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