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moved in on the low today
savor this, the only one coming;
i2.26 ---> o2.66 ... xx,xxx. or better explained XX,xxx .
One tense day and its almost like last fall never even happened. Amazing.
Meanwhile back at the kilns,
0.069900, +0.0049. + 7.54% !!! A great come story back hurrah.
Breaking out the bubbly.
good luck longs. Nice to read some old faces
RGDX management - common ancestry with CBMX
sorry for the hodge podge, was distilling info from Co website,
but CEO has a great CV. Solid surrounding players too.
Thomas A. Bologna CEO 12/11 to current.
prior experience;
P, CEO Orchid Cellmark, Inc. 4/06 - 12/11
"Dec 16, 2011 - LabCorp secures >90% of Orchid Cellmark shares, clearing a speedy close to the $85 million short-form merger acquisition…after waiting eight months for US FTC blessings. Orchid traded from 1.39 to 1.99 in the year before the offer/acquisition for ~2.80/share.
P CEO BOD of venture-backed Quorex Pharmaceuticals, Inc., where he orchestrated a successful sale to Pfizer Inc.
COB, P, CEO of Ostex International, oversaw the sale of Ostex to Alere Inc. (formally Inverness Medical Innovations).
P, CEO of Scriptgen Pharmaceuticals, Inc
COB, P, CEO Gen-Probe, Inc (global leader in the development, manufacture and marketing of molecular diagnostic products), leading Gen-Probe through IPO on NASDAQ to sale to Chugai Pharma.
Mr. Bologna held senior-level positions with Becton Dickinson & Company and Warner-Lambert Company (Pfizer)
Mr. Bologna served as President of the Becton Dickinson Diagnostic Instrument Systems Division and as a Vice President of the Warner-Lambert Company.
Stephanie H. Astrow, PhD, VP R&D
Scientific Director for Oncology at Quest Diagnostics
Vice President and Director of Oncology at Pathway Diagnostics, and Vice President, Scientific Director of Impath, Inc.
Mark Balsano: VP Sales 4/13- present
Prior
VP Sales at Poplar Healthcare, leading the Oncology and Women’s Healthcare Divisions.
VP Sales and Marketing at Consultants in Radiology.
Alan Cheeks, M.A.: Sr Dir Laboratory Operations July, 2012,
13 years of laboratory and operations management experience i
Prior
Peregrine Pharmaceuticals, managed clinical trial operations for the oncology pipeline.
Quest Diagnostics managed the clinical studies team
IMPATH Dir Clinical Trials at Pathway Diagnostics
Director of Cellular Oncology at IMPATH.
other
http://www.responsegenetics.com/about-us/management-and-board/
BOD
Kirk K. Calhoun Ernst & Young LLP1965 (1975 partner) 2002 ret.
Served on BOD and Audit of 5 pharma Cos … up to their respective sales (Abraxis Biosci, Myogen, Aspreva Pharma., Replidyne, Adams Respiratory Therapeutics,)
Sam Chawla
Portfolio Manager of Perceptive Advisors LLC, Credit Opportunities Fund
Managing Director at UBS Securities
Director, VP in the Healthcare Investment Banking Group of Credit Suisse LLC
David R. Schreiber
25 years executive in diagnostics.
more
note, long RGDX
I dont care whether you are long, short, taller or better looking than me.
Read again the letter you posted, it mainly addresses the daily FINRA long/short data, which of course is nearly useless as an indication of shorting (it's bookkeeping) for the reasons listed in your letter (MM executing trades risk-less regarding their inventory). That daily data is accessible here and elsewhere http://www.shortvolume.com/
The Failure to Deliver data is more an indicator of how many shares were counterfeited (sold but not actually provided to buyer in due time...) in a certain period. If you are long & OK with that, what ever, but I am not. Its a fraudulent sale and it causes downward price pressure.
Available here http://failstodeliver.com/default2.aspx
and related to here http://www.nasdaqtrader.com/Trader.aspx?id=RegSHOThreshold
GEVO is hard to borrow because it "excessively" shorted, but that didn't stop crook shorts from selling non existant stock anyway, putting additional pressure on the stock and forcing extra dilution to raise the necessary funds.
Of course the actual FTD is probably far higher than reported too, because crooks use new FTD shares to settle old FTD shares, rolling the scam forward.
thanks for the opportunity to teach something.
RE: daily report useless for monitoring Short / Long activity;
"Often, to carry out that function, broker- dealers will handle such investor orders on a riskless principal basis. A riskless sale is one in which a broker-dealer, after having received an order to sell a security, sells the security as principal, at the same price, to satisfy that order. Regulations require broker-dealers to mark their proprietary riskless sell order as short if they don't own the security, even if the customer order to sell the security is long."
If you're Long, complain to SEC about this chart
http://failstodeliver.com/default.aspx
FTD skyrocket for GEVO.
and this data
http://www.nasdaqtrader.com/trader.aspx?id=regshothreshold
GEVO on threshold for nearly a month.
Retrofitting Ethanol Plants for Isobutanol powerpoint
June 12, 2013
http://www.fuelethanolworkshop.com/files/docs/2013/Lund_Brett.pdf
done
transcript, ENDOCRINOLOGIC AND METABOLIC DRUGS ADVISORY COMMITTEE, 10/16/2013:
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM376102.pdf
posted to INTRO too
Coke definitely still involved with GEVO
Gevo, Coke, Toray Partner on Renewable PET Technology August 27, 2013
...The Coca-Cola Company’s Scott Vitters, general manager, PlantBottle packaging innovation platform, says while the technology to make bio-based materials in a lab has been around for several years, Coke believes Gevo’s technologies have the potential to create it on a global commercial level within the next few years.
Gevo’s Silsbee facility is “an important milestone” toward Coke’s vision of making all of its PET plastic packaging from responsibly-sourced plant materials, Vitters says."
...Toray has also signed an offtake agreement for paraxylene produced at the Silsbee facility
Coke attended ribbon cutting of Silsbee
http://www.beaumontenterprise.com/news/article/Silsbee-based-company-teams-with-Coca-Cola-to-4782792.php
Mike Schultheis, Principal Engineer Sustainable Packaging Global R&D of The Coca-Cola Company, spoke Aug. 26 at Gevo's bio-paraxylene and bio-jet plant at South Hampton Resources in Silsbee. (pix 18)"
"The majority of the world's PET production is for synthetic fibers (in excess of 60%), with bottle production accounting for around 30% of global demand. "
Today or next year?
Coke Ford Gevo. google it
Another 25,000 shares bought at market for Sol Barer.
http://www.sec.gov/Archives/edgar/data/1138776/000114420413060657/xslF345X03/v360190_4.xml
72,000 owned by public purchase.
Nov 11 2013
MDGN Medgenics, Inc. Barer Sol J Director 25,000 Purchase at $6.80 $170,123
Sep 20 2013
MDGN Medgenics, Inc. Barer Sol J Director 20,000 Purchase at $6.50 $129,996
Sep 19 2013
MDGN Medgenics, Inc. Barer Sol J Director 20,000 Purchase at $5.57 $111,478
TYall. Clarification; kanazawayoshi(ymb)/Takiko(sa) is author.
An excellent document to send to your reps.
https://docs.google.com/file/d/0B8QAeiZHmD6hZ0RJTXFzdHd2U0U/edit?usp=sharing
His entire stream is worth reviewing, paste the following after the home URL for those
sa; user/11023011/comments
y; /mbview/userview/;_ylt=Avoc0Dn.BZAY1iYVfPgJ58zeAohG;_ylu=X3oDMTB2bmdscmVoBHBvcwM2MQRzZWMDTWVkaWFNc2dCb2FyZHNYSFJVbHQ-;_ylg=X3oDMTBhYWM1a2sxBGxhbmcDZW4tVVM-;_ylv=3?&u=kanazawayoshi&bn=9ab0d884-3173-3957-a618-d4a469a0d4c3
Dear Member of Congress letter. kanazawayoshi
https://docs.google.com/file/d/0B8QAeiZHmD6hZ0RJTXFzdHd2U0U/edit?usp=sharing
zuman! you made sticky. way overdue.
Great post on phenomenal presentations
Did it again today. When life hands out lemons, order the lobster.
Quiting time
AMRN briefing doc has 32hits searching terms "inflammation/inflammatory" http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/endocrinologicandmetabolicdrugsadvisorycommittee/ucm370987.pdf
How Often Does FDA Agree With Panels?
http://www.pharmalive.com/how-often-does-fda-agree-its-panels
Posted Thu, 10/14/2010 - 8:34am by Ed Silverman
After most FDA advisory committee meetings, the standard reaction to any vote is the FDA does not have to follow the advice of its panels, but often does. But is that really true? Well, it turns out the agency does follow recommendations from its advisory committees most of the time - 74 percent, to be exact, according to Prevision Policy.
Another issue closely tracked is whether the agency makes its decisions on time. And the answer is...60 percent are, indeed, delivered on time. Of course, this means 40 percent are not. On time, by the way, was defined as making a decision by the user fee deadline, while a delayed decision meant the agency missed or took action that allowed a formal extension.
To reach this conclusion, Prevision Policy analyzed Center for Drug Evaluation & Research advisory committee decision from 2007 through 2010.
All new molecular entities and new indications for existing marketed drugs were reviewed, which amounted to more than 120 cases in the last four years, the firm indicates.
And for those of you curious to know how each committee fared, please keep reading...
Anesthetic &Life Support 50% are on time 78% are consistent
Anti-Infectives 56% are on time 63% are consistent
Anti-Viral 40% are on time 80% are consistent
Arthritis 100% are on time 71% are consistent
Cardio-Renal 64% are on time 62% are consistent
Dermatologic and Ophthalmic 71% are on time 71% are consistent
Endocrinologic & Metabolic 33% are on time 75% are consistent
Gastrointestinal 50% are on time 100% are consistent
Oncologic 68% are on time 82% are consistent
Peripheral & CNS 25% are on time 100% are consistent
Psychopharm 42% are on time 75% are consistent
Pulmonary-Allergy 75% are on time 63% are consistent
Reproductive Health 89% are on time 67% are consistent
Errata to the FDA Briefing Information for the October 16, 2013 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (PDF - 77KB)
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM370986.pdf
from
Briefing Information for the October 16, 2013 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/ucm370984.htm
TEMP MEMBERS(VOTING) Peter W.F. Wilson, MD
Professor of Medicine Emory University School of Medicine Department of Cardiology Atlanta, Georgia
7. OPERA and FORWARD Death knell for fish oil in atrial fibrillation Results: Short-term administration of fish oil to patients undergoing heart surgery did not reduce the incidence of postoperative atrial fibrillation (AF) according to the results of the OPERA trial. There was no difference between the active- treatment and placebo groups in terms of preventing postoperative AF, despite the fact that patients in this study were given fairly high doses of fish oil in the form of a prescription product. This assertion was borne out in a second trial, Fish Oil Research with Omega-3 for Atrial Fibrillation Recurrence Delay (FORWARD), performed in people with previous AF, to see whether 1 g per day of fish oil would prevent recurrences. It did not. "Every time weve had a major trial using omega-3s that was conducted as a primary purpose of the trial, weve come up short. Its very discouraging for the omega-3 story," said invited panel member Dr Peter Wilson (Emory University, Atlanta). See: OPERA does not sing praises for fish oil in AF
http://www.slideshare.net/theheartorg/aha-2012-research-highlights
http://mobile.reuters.com/article/healthNews/idUSBRE8A413J20121105?irpc=962
kay - Hiatts pubs https://profiles.ucdenver.edu/display/224140
#1 & 3 look interesting, have not been able to open yet
Found he co-authored a paper with GSK person but I lost track of it since yesterday
http://www.foxnews.com/health/2013/06/07/fda-panel-votes-to-relax-avandia-restrictions/
FDA panel votes to relax Avandia (GSK) restrictions
Avandia was once the world's best-selling treatment for type 2 diabetes, with annual sales of $3.2 billion.
"In general, this drug doesn't look any different than any other diabetes drug," said Dr. William Hiatt, a cardiologist from the University of Colorado, who was among seven experts who backed lifting restrictions altogether.
In 2010 its use in the United States was heavily restricted and it was withdrawn from the market in Europe because of the possibility of increased risk of heart attack and stroke. Only 3,000 people in the United States take it today, down from about 120,000 just before the restrictions were put in place.
Webcast Information; Meeting of Endocrinologic/Metabolic Drugs Advisory Committee (EMDAC) October 16, 2013
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM370983.pdf
The meeting webcast can be accessed at the following web address:
https://collaboration.fda.gov/emdac2013/
Note: At the access page, please sign in as a guest. No password is required.
so after "6-8week leadin period for dietary instruction, washout of non-statin lipid- modulating drugs, and stabilization of statin therapy,"
participants go back to their same old habits and the statins become less effective ? The charted effects ARE due to V even in the face of normal human behavior.
15 of 15 here, see ya around !
Have the briefing documents been published for the October 16, 2013, FDA Advisory Committee Meeting to consider Amarin's proposed Vascepa labeling expansion to include patients studied in the ANCHOR trial?
http://investor.amarincorp.com/faq.cfm
Yes. The FDA published both the FDA and Amarin briefing documents on October 11, 2013. The briefing documents and related information are available on the FDA’s website at:
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs
/EndocrinologicandMetabolicDrugsAdvisoryCommittee/ucm331504.htm
Amarin looks forward to the Advisory Committee Meeting to discuss the approval rationale for Vascepa in the ANCHOR population.
FDA discussion point and question are consistent with those typically presented at advisory committee meetings and provide perspective on the feedback FDA will seek from its outside advisors at the meeting. The meeting will provide Amarin the opportunity to present the ANCHOR data, its clinical significance and Amarin’s degree of confidence that lipid changes exhibited in the ANCHOR trial will translate into a meaningful reduction in cardiovascular risk among the target population.
Amarin will hold a conference call on October 16th at 7:00 pm Eastern time to discuss the results of the Advisory Committee Meeting. The meeting is scheduled to take place from 8:00 am to 5:00 pm Eastern time. Amarin is currently in a quiet period, and thus has no plans to comment on the briefing documents or the Advisory Committee Meeting until the planned conference call.
The FDA discussion point and question for the meeting are repeated below:
1. DISCUSSION:
In ANCHOR, 12 weeks of treatment with Vascepa 4 g/day led to an estimated median -21.5% (95% CI, -26.7% to -16.2%; P<0.0001) change in fasting triglycerides, compared with the mineral oil placebo, among statin-treated patients with mixed dyslipidemia at high cardiovascular risk. Changes in other lipid/lipoprotein parameters (selected secondary and exploratory endpoints) are summarized in the table below.
Please discuss the efficacy results from the ANCHOR trial, including the clinical significance of the observed changes in lipid/lipoprotein parameters and your level of confidence that these changes will translate into a meaningful reduction in cardiovascular risk among the target population.
2. VOTE:
Taking into account the described efficacy and safety data for Vascepa, do you believe that its effects on the described lipid/lipoprotein parameters are sufficient to grant approval for co-administration with statin therapy for the treatment of patients with mixed dyslipidemia and CHD or CHD risk equivalent prior to the completion of REDUCE-IT? Please provide the rationale underlying your recommendation.
The FDA and Amarin briefing documents also explore the following topics:
ANCHOR Rationale and Design/Conduct
ANCHOR Study Population
Unmet Medical Need in Mixed Dyslipidemia
ANCHOR Efficacy Results
Vascepa Safety
Benefit/Risk Assessment
Benefit/Risk Evaluation in Context of Current Scientific Knowledge
if only one was. B.N.Greedy time
corn oil placebo
lol pit stop, in
I thought you were going to tie this back to MIA CONtributors jheer
Join in filing a complaint to the SEC with this information about manipulative desks leaping outside the NBB to steal stop loss shares. I am aware of fines and corrective action resulting from such complaints in other cases.
bulk shares print OUTSIDE the National Best Bid
despite huge available bids at the moment.
time
vol bid price ask
9:19:52
150K 5.76 / 5.75 / 5.77
9:19:58
10K 5.80 / 5.76 / 5.81
9:21:52
50K 5.95 /5.75/ 5.96
Fudging Hedge tricks.
Is the SEC shut down too ?
ok, just quick scanning some notepad info, feel free to add to or ignore
JP Morgan note."Upside/Downside". With an upcoming FDA AdCom meeting on V to treat TG fast approaching....we wanted to share our
thoughts on the risk/reward on AMRN shares into the event. Overall, we believe a positive panel is highly likely and view the ANCHOR
indication for high TG as the primary value driver of the stock, targeting a potential market 10X the size of V's current label.
While we see fairly equal upside/downside cases for the stock ($2-3),we believe the probability of a positive recommendation (>80%)
far ouweighs that of a negative one (<20%). Amarin is operating under a SPA with the FDA and has highly positive data from its ANCHOR
and MARINE studies as well as a very clean safety profile with V. While we believe the commercial potential of V will remain a source
of controversy in the story, a positive panel woudl help de-risk the pathway to aproval for an indication that accounts for 70%+ of
our DCF. Although we see the prob of a neg panel as low we believe the possibility exists for the FDA to ask AMRN to finish its
REDUCE IT outcomes studies (expected by 2018) before approving its label expansion. While the 4+ year delay would clearly negatively
impact our DCF we believe the label expansion would ultimately be approved and we see clear value in AMRN's Irish corporate structure which
we think would help set a floor on the stock
thx http://stocktwits.com/homebuilder_watcher
William R. Hiatt,, M.D. Endocrinologic/Metabolic Advisory Committee Member
some dd
CURRICULUM VITAE (2012)
William R. Hiatt, MD, FACP, FAHA
Novartis Foundation Professor for Cardiovascular Research Section of Vascular Medicine Division of Cardiology University of Colorado School of Medicine President, CPC Clinical Research
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM354664.pdf
108. Sommerfield T, Hiatt WR. Omega-3 fatty acids for intermittent claudication. Cochrane Database Syst Rev 2004;3:CD003833.
Omega-3 fatty acids for intermittent claudication.
http://www.ncbi.nlm.nih.gov/pubmed/17943801
Abstract
BACKGROUND:
Omega-3 fatty acids are established as being effective in the treatment and prevention of coronary artery disease. It is possible that they may also benefit people with peripheral arterial disease, since the pathogenesis of the two conditions is similar.
MAIN RESULTS:
Six studies were included representing 313 participants. All studies compared omega-3 fatty acid supplementation with placebo lasting from 4 weeks to 2 years. Two studies with long treatment periods administered additional substances, making any observed effects impossible to attribute to omega-3 fatty acids and were therefore excluded from the statistical analyses. No significant differences between intervention and control groups were observed in ankle brachial pressure index (ABPI) (weighted mean difference (WMD) -0.02; 95% CI -0.09 to 0.05), systolic blood pressure (WMD 5.00 mmHg; 95% CI -11.59 to 21.59), plasma viscosity (WMD 0.03 mPa/s; 95% CI -0.02 to 0.08), pain-free walking distance (PFWD) (WMD 7.46 m; 95% CI -25.47 to 40.39), or maximal walking distance (MWD) (WMD 0.27 m; 95% CI -39.59 to 40.13). Blood viscosity levels decreased. Gastrointestinal side effects were observed in two studies. Omega-3 fatty acid supplementation increased (low-density lipoprotein) LDL cholesterol levels (WMD 0.80 mmol/litre; 95% CI 0.34 to 1.26) and total cholesterol levels (WMD 0.64 mmol/litre; 95% CI 0.08 to 1.20).
AUTHORS' CONCLUSIONS:
Omega-3 fatty acids appear to have limited haematological benefits in people with intermittent claudication but there is no evidence of consistent improved clinical outcomes which are the primary outcomes of this review (quality of life, PFWD, MWD, ABPI, angiographic findings). Supplementation may also cause adverse effects such as increased total and LDL cholesterol levels. Further research is needed in this area, to evaluate short- and long-term effects on more clinically relevant outcomes.
~~~~~~~
https://profiles.ucdenver.edu/display/202142
Fatty Acids, Omega-6
This graph shows the total number of publications written about "Fatty Acids, Omega-6" by people in Colorado PROFILES by year, and whether "Fatty Acids, Omega-6" was a major or minor topic of these publication.
William R Hiatt
https://profiles.ucdenver.edu/display/224140
Smith RJ, Hiatt WR. Two new drugs for homozygous familial hypercholesterolemia: managing benefits and risks in a rare disorder. JAMA Intern Med. 2013 Sep 9; 173(16):1491-2.
View in: PubMed
JAMA Intern Med. 2013 Sep 9;173(16):1491-2. doi: 10.1001/jamainternmed.2013.6624.
Two new drugs for homozygous familial hypercholesterolemia: managing benefits and risks in a rare disorder.
Smith RJ, Hiatt WR.
Source
Department of Medicine, Alpert Medical School of Brown University, Providence, Rhode Island2Ocean State Research Institute,
Berger JS, Hiatt WR. Medical therapy in peripheral artery disease. Circulation. 2012 Jul 24; 126(4):491-500.
View in: PubMed ( wont open)
http://circ.ahajournals.org/content/126/4/491.extract
Pg1 pdf
Ellen W. Seely, M.D. Endocrinologic/Metabolic Advisory Committee Member
Ellen W. Seely, M.D.
Expertise: Endocrinology, Metabolism, Diabetes
Term: 04/25/2011 – 06/30/2014
Professor of Medicine
Harvard Medical School
Division of Endocrinology, Diabetes and Hypertension
Brigham and Women’s Hospital
221 Longwood Avenue
Boston, Massachusetts 02115
Curriculum Vitae
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/ucm271255.pdf
searchmedica.com
http://www.searchmedica.com/search.html?q=ellen%20seely,%20m.d.%20omega&c=pc&ss=defLink&fr=true
search terms; ellen seely, omega, epa, dha
no germane hits
http://www.searchmedica.com/search.html?q=ellen%20seely,%20%20omega&c=pc&ss=defLink&fr=true
or, they hedged their long shares ( possible even recent follow on shares) against the not-impossible (not probable).
.15 ~ .18 insurance against a buck loss, and if AdCom rocks, the gain will dwarf the expired puts.
Endocrinologic and Metabolic Drugs Advisory Committee Roster;
http://www.fda.gov/advisorycommittees/committeesmeetingmaterials/drugs/endocrinologicandmetabolicdrugsadvisorycommittee/ucm096416.htm
Committee Member
Erica H. Brittain, Ph.D.
Expertise: Biostatistics
Term: 05/31/2011 – 06/30/2014
Mathematical Statistician
Biostatistics Research Branch
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health (NIH)
6700A Rockledge Drive (Room 5132) Bethesda, Maryland 20817
http://www.diabetesincontrol.com/articles/diabetes-news/11242-diabetes-drug-dapagliflozin-rejected-by-fda-panel&action=1&action=1
Diabetes Drug Dapagliflozin Rejected by FDA Panel
A federal advisory committee voted 9 to 6 on July 19 that a first-of-its-kind diabetes drug should not be approved for use because of safety concerns, including a possible increased risk of breast and bladder cancers....
Several committee members said they could have voted either way.
"I changed my mind about four times in the last 10 seconds," said Erica H. Brittain, a statistician at the National Institutes of Health who voted 'no.'
wtf?!?!
About 0.4 percent of women taking the drug got breast cancer, compared with 0.1 percent of the women in the control groups. About 0.3 percent of men getting the drug got bladder cancer, compared with about 0.05 percent of men in the control groups.
The numbers were very small, however, making it hard to draw definitive conclusions. Bristol-Myers and AstraZeneca argued that many of the cancers occurred too soon to have been caused by the drugs. Still, some committee members said the imbalance could not be overlooked. "The breast and bladder cancers, I can't dismiss as being irrelevant or minor," said Dr. Doris B. Strader of the University of Vermont.
FDA Rejects Dapagliflozin for Type 2 Diabetes - MedPage Today
www.medpagetoday.com/Endocrinology/Diabetes/30747?
Jan 19, 2012 - WASHINGTON -- The FDA said it would not approve the novel diabetes drug dapagliflozin until drugmakers Bristol-Myers Squibb and ...
FDA Accepts NDA Resubmission of Diabetes Drug Dapagliflozin
www.medscape.com/viewarticle/808480?
Jul 26, 2013 - If eventually approved in the United States, dapagliflozin will not be the first SGLT -2 inhibitor on the market. Earlier this year, the FDA cleared ...