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NSTR Northstar Neuro
Is anyone familiar with this company and/or the field of cortical stimulation for depression and stroke?
The company has almost $78 million (enough to fund research well into 2011) and an enterprise value of about - $30 million.
There has been massive and consistent insider buying.
DSCO: If there is to be a delay, would you expect the FDA to announce it before the PDUFA date?
Also, is the requirement for stability six months or longer?
ZGEN
Briefing.com has a rating reiteration of "Buy" from Brean Murray for today, February 14. I guess that's a mistake.
ZGEN: Brean Murray reiterated a buy, not a sell, on ZGEN today according to the report I saw. Isn't that the case?
DSCO:<the only real hold up has been stabilization issues in the manufacturing, which they seem to have gotten a handle on lately...>
What evidence is there for saying they have gotten a handle on manufacturing lately?
I do feel that the insider buying is a positive sign.
<The other possible explanation for the insider buying is that bad news of some sort is imminent.>
What is the rationale for that statement? Why would there be buying if bad news was imminent?
Competing methods: After having reviewed the read-me first I am uncertain about the competitive threat to GTCB posed by improved mammalian cell anti-body production methods and plant based production of therapeutic proteins. I know that the topic has been discussed, probably extensively, in the past, but I would appreciate some current guidance as it is the one factor that is giving me some hesitation about investing in GTCB.
MCU/drbio45
drbio, I noticed you were on the MCU conference back in August following the acquisition of the Aggrastat line in the US from Merck. I value your insights and wonder if you are still following MCU and might share your opinion of the company.
MCU/Increase in institutional holdings. Interesting....
Holdings Summary
MCU MCU
MEDICURE INC Amex
Institutional Holdings Description | Hide Summary
Company Details
Total Shares Out Standing (millions): 96
Market Capitalization ($ millions): $136
Institutional Ownership: 17.1%
Price (as of 9/14/2006) 1.42
Ownership Analysis # Of Holders Shares
Total Shares Held: 22 16,414,467
New Positions: 10 7,470,350
Increased Positions: 14 8,087,667
Decreased Positions: 7 756,500
Holders With Activity: 21 8,844,167
Sold Out Positions: 3 340,700
MCU/rfj1862
rfj1862, do you still follow MCU? I think the stock looks attractive with MC-1 about to go into a Phase 3 with a partner likely. The acquisition of Aggrastat from Merck and the development of a small sales force seems a promising step as well.
Any thoughts?
Iloperidone/poorgrad
<a pointless "diversification" into TTP back when iloperidone still seemed to matter.>
Why do you think iloperidone no longer matters? JP Morgan et al raised closed to 60M earlier this year for Vanda largely on the strength of prospects for iloperidone. Vanda, moreover, was founded by former Novartis executives involved with development of iloperidone.
What biotechs are likely to benefit from the following news?
Scientists Use Gene Therapy
To Shrink Malignant Tumors
By MARK SCHOOFS
August 31, 2006 2:00 p.m.
For the first time in the history of treating cancer, gene therapy has apparently succeeded in shrinking and even eradicating large, metastatic tumors.
The therapy worked in only two of 17 patients who were treated. But many researchers are hailing the study, which was published Thursday in the online edition of Science, as groundbreaking because it provides compelling evidence in human patients that gene therapy can be effective against one of the toughest challenges in medicine: terminal cancer.
Moreover, the technique used in this pilot study -- genetically altering immune-system cells so that they target tumors -- could eventually apply to many different kinds of cancers, not just the cancer that afflicted patients in this trial, which was melanoma.
"It's very impressive," said David Baltimore, the Nobel laureate who is himself conducting similar research. Dr. Baltimore noted key caveats: Only a small number of patients responded to the treatment, and the study's lack of a control group means there is no way to be absolutely sure that the treatment was responsible for their improvement. Given the fact that those patients had late-stage melanoma that almost never goes into remission on its own, had failed all conventional treatment, and responded as soon as they were given the experimental treatment means "it's likely" that gene therapy is what worked against their cancer, said Dr. Baltimore. "But likely and proven are two different things," he cautioned.
Still, Dr. Baltimore called the study "a significant step forward that tells me about directions to go in" with further research.
[gene_therapy.jpg]
These three CAT scans, taken at different times over 10 months, show the liver of Mark Origer, a patient treated with experimental gene therapy. The dark round spot on the left is a tumor, a metastasis caused by melanoma. The first scan shows the tumor just before Mr. Origer was given billions of genetically engineered T-cells. In the second scan, taken one month after the treatment, the tumor has shrunk in volume by about 2/3. The third scan, taken 10 months after the treatment, shows the tumor has shrunk by almost 90% from its pre-treatment size.
The findings arrive on the heels of some positive developments for gene therapy, which involves inserting genes into a patient's cells to compensate for an inherited genetic defect or to enable the body to fight a disease on its own, without taking medicine. Many scientists believe it is the future of medicine, but the field has suffered from maximal hype, minimal success, and even a few disastrous side effects, including therapy-induced leukemia and death.
BIVN. Does anyone have an opinion about their Hep C drug, Suvus? The stock seems to be gathering strength.
TIA
Rstor, do you still follow Inovio? Now that they have raised money, what is your view on the stock?
Tia.
iwfal/PCYC.
Thanks very much iwfal. I'm also in the pondering phase at this point.
Pharmacyclics/iwfal: Did you ever complete your dd on PCYC?
The main thing that bothers me is the narrowness of the margin of success (p = .048) for the nsclc/brain mets sub-group that was prespecified and stratified in the previous Phase 3. The current trial is, of course, limited to nsclc/brain mets patients, they have enrolled more than twice as many as in the first trial and have apparently refined their method of determining time to neurological progression.
I think the reward side of the risk/reward equation is quite sizable particularly considering the very large short interest.
Any comments?
SPPI/PCYC If I remember correctly Dew posted a while back that the first scheduled look at the data for satraplatin (in first quarter '06 I believe) has a very stringent P value requirement that he thought it is unlikely to meet. I believe he said that for that reason he was holding off on GPCB.
Anyone care to venture an opinion on prospects for Pharmacyclics NSCLC/brain mets tial???
Pharmacyclics (PCYC)Results from their second Phase 3 trial are supposed to be released before year end. The first Phase 3 failed to meet its primary endpoint, time to neurological progression (brain metastases), but a pre-specified, stratified subgroup consisting of lung cancer patients (60% of the overall population)did meet its primary endpoint with P value of .048 and HR of 61. Very large market potential if successful.
Does anyone have any comment on the second Phase 3 trial's likelihood of success?
I agree. GNVC is undervalued. Their current decline of almost 25% seems to have been precipitated by their announcement that they were stopping myoblast development, a program that clearly was of very minor importance to them and that was employing resources much better spent on their very promising other programs - particularly their oncology work with TNFerade and their cardiac Biobypass program.
GNVC
GAITHERSBURG, Md.--(Business Wire)--Oct 05, 2005--
GenVec, Inc. (Nasdaq:GNVC.Q) announced today that it has
received a $9.9 million increase in funding for its HIV vaccine
development work with the Vaccine Research Center (VRC) of the
National Institute of Allergy and Infectious Diseases (NIAID),
National Institutes of Health. The VRC will utilize GenVec's
proprietary technologies for vaccine development, including its
production cell line, 293-ORF6, to design and test next-generation
vaccines to optimize the body's immune response to HIV. GenVec is
working under a subcontract, issued and managed by SAIC-Frederick,
which now totals approximately $50 million and extends through 2008.
GenVec, working with the VRC, has already developed and produced
an adenovector-based vaccine containing DNA segments from the three
major HIV subtypes, or "clades," responsible for 90 percent of HIV
infections worldwide. In clinical trials being conducted by the VRC,
this adenovector-based vaccine has been administered to more than 140
volunteers either alone or in combination with a plasmid DNA vaccine
as a "boost" in 6 ongoing or completed Phase I studies. In addition,
this adenovector-based vaccine will be used in upcoming Phase II
clinical testing anticipated to enroll volunteers in the U.S., Haiti,
Brazil, Trinidad, South Africa and Botswana.
GenVec is a publicly held clinical-stage biopharmaceutical company
focused on the development and commercialization of novel therapies
that improve patient care in the areas of cancer and cardiac disease,
and to prevent vision loss. GenVec's vaccine program applies the
Company's unique delivery technology and 293-ORF6 cell line to develop
vaccines against a variety of diseases, including HIV, malaria, and
foot and mouth disease. The vaccine candidate discussed in this
release has not been approved by the U.S. Food and Drug Administration
or any other regulatory agency. GenVec is not responsible for the
design or conduct of the clinicaltrials discussed in this release.
Additional information on GenVec is available at www.genvec.com and in
the Company's various filings with the Securities and Exchange
Commission.
Statements herein relating to future financial or business
performance, conditions or strategies and other financial and business
matters, including expectations regarding future programs and studies,
are forward-looking statements within the meaning of the Private
Securities Litigation Reform Act. GenVec cautions that these
forward-looking statements are subject to numerous assumptions, risks
and uncertainties, which change over time. Factors that may cause
actual results to differ materially from the results discussed in the
forward-looking statements or historical experience include risks
relating to the early stage of GenVec's product candidates under
development; uncertainties relating to clinical trials; the timing and
content of future U.S. Food and Drug Administration regulatory actions
with respect to GenVec, its product candidates, or collaborators,
risks relating to the commercialization, if any, of GenVec's proposed
product candidates (such as marketing, regulatory, patent, product
liability, supply, competition and other risks); dependence on the
efforts of third parties; dependence on intellectual property; and
risks that we may lack the financial resources and access to capital
to fund our operations. Further information on the factors and risks
that could affect GenVec's business, financial conditions and results
of operations, are contained in GenVec's filings with the U.S.
Securities and Exchange Commission (SEC), which are available at
www.sec.gov. These forward-looking statements speak only as of the
date of this press release, and GenVec assumes no duty to update
forward-looking statements.
CONTACT: GenVec, Inc.
Rena Cohen, 240-632-5501
rcohen@genvec.com
KEYWORD: 'UNITED STATES' 'NORTH AMERICA' 'MARYLAND'
INDUSTRY KEYWORD:'HEALTH' 'AIDS' 'BIOTECHNOLOGY'
'INFECTIOUS DISEASES' 'OTHER HEALTH'
SOURCE: GenVec, Inc.
Copyright Business Wire 2005
Re GTCB
From the YMB:
<EMEA approval
by: byrn02
Long-Term Sentiment: Strong Buy 09/14/05 02:22 pm
Msg: 22719 of 22725
Until this moment:
Approval periode 1998 - 2004 96%
Approval periode 2005 100%>
Does anyone know if these statistics are accurate? If not, does anyone know what the actual approval percentages are?
Dew: Do you mean to have us believe that they raised wholesale prices by about 6.6% and gave it all back in the form of rebates and discounts?
Telik. Thanks poorgrad for a very thoughtful reply. I was impressed with the data the company released in July concerning two NSCLC trials. The objective response and disease stabilization rates were quite high (58% and 92% respectively in one trial and 32% and 88% in the other). What do you think of that data?
Thanks again.
Canadian Health Care. What do you expect the WSJ to say on the subject? Any well financed news organization with an axe to grind can collect oddball quotes from physicians and so called "institutes" to paint a drastically biased view. That is not to say that the Canadian system doesn't have drawbacks, but it has virtues as well, particularly universal coverage.
Telik/ Poorgradstudent, I know that you have commented favorably on Telik in the past, but note that you have not said anything recently. I would be interested in your current opinion of the company and particularly of the prospects for Telcyta.
Tia
<even worse for the lack of confidence it shows in the ATryn review.>
Dew, do you still stand behind that viewpoint?
CATG/Humira: You may be right after all drbio. While the royalty with respect to Abbott/CATG is either a little over 5% or 2% depending upon who prevails in the litigation, CATG has an obligation to pay approximately one-third of the amount to an entity called MRC (Medical Resource Corp. I believe) bringing the net to CATG to slightly above 3% or slightly above 1 %. Still will amount to a nice piece of change for a drug with multi-billion dollar potential.
rstor we need you.
CATG/Humira
Dew, do you think that given the "monster" status of Humira, and the other things CATG has going for it, the stock might be grossly undervalued?
CATG - Extremely undervalued on basis of Humira royalties alone.
A few facts about CATG: Enterprise value of 314M (345M cash, 51.46M shares). In litigation with Abbott over percentage of royalties it gets on Humira. Abbott says 2%, CATG says over 5%. CATG won the first legal round. Abbott is appealing.
Abbott just reported 2d quarter sales for Humira of 321M, up 58.4% (603M for first half, up 71.5%). Said earlier in the year it expects Humira sales to be over 2 Billion shortly.
Additional major indications expected: S&P expects approval of Humira in psoriatic arthritis setting in 2d half '05, believes it could be approved for Crohns and psoriasis in '07.
On 6/27/05 EMEA recommended approval as first line treatment of moderate to severe early rheumatoid arthritis as well as psoriatic arthritis. Expected European Commission authorization decision expected at end of September.
If he knew he couldn't sell after exercising, and his purpose in exercising was to sell, he would not have exercised. Make sense? I'm not entirely sure myself.
Can you say what led BTM to the conclusion that there was "a slightly higher risk than what they previously believed"?
Has anyone come across any upcoming AACR abstracts with likely market impact, no matter how slight or transitory?
Bob, I agree that the Insmed manufacturing patent situation looks strong and that, on the other hand, the DNA use patent for catabolic processes creates a far less clear situation. However, the willingness of investors to loan Insmed 35M$ surely must be based on the clear conviction, after careful legal counsel, that the IP situation will not prevent Insmed from operating. Do you agree?
Of course, I originally thought that the ability of Tercica to raise 80M$ (I believe) in its IPO in the face of the existence of Insmed meant that it and its backers were convinced that they had the upper hand in the patent situation. A truly amazing sequence of events.
Bob, what is your assessment of the patent challenge to INSM?
TIA
drbio, what do you think of DOR currently? Do you think Orbec will be approved?
There is a fascinating panel discussion webcast on "Gene Therapy. Are we there yet?" from the BioCeo Conference held yesterday. The webcast is currently available at a number of different sites, including www.genvec.com. I would particularly recommend the comments of Paul Fischer, CEO of Genvec. He is about the fifth or sixth speaker on the webcast. I think he puts gene therapy in a new light.
Amazing that someone would want to brag about that.
Did anyone see the Acuity Pharmaceutical (private) gene silencing for AMD segment on the CBS Evening News with Dan Rather?
Mea culpa.
I didn't realize Ilex has a merger agreement with Genzyme. Makes my previous post largely irrelevant.