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give mom my very best!!!!!!!!
remember me ??????
yes i got burned off that posting
KERX Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX) today announced successful top-line results from the long-term Phase 3 study of Zerenex(TM) (ferric citrate), the Company's ferric iron-based phosphate binder drug candidate, for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with end-stage renal disease (ESRD) on dialysis. In this study, Zerenex met the study's primary endpoint, described below, demonstrating a highly statistically significant change in serum phosphorus versus placebo over the four-week Efficacy Assessment Period of the study. In addition, Zerenex met the key secondary endpoints of increasing ferritin and transferrin saturation (TSAT) and reducing the use of intravenous (IV) iron and erythropoiesis-stimulating agents (ESAs) versus the active control over the 52-week Safety Assessment Period of the study. This long-term study was the final component of the Company's Phase 3 registration program, which was conducted pursuant to a Special Protocol Assessment (SPA) with the Food and Drug Administration (FDA). In April 2011, the Company reported the positive final dataset from the short-term study component of this Phase 3 registration program. The Company expects to submit a New Drug Application (NDA) with the FDA and a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for Zerenex in the second quarter of 2013.
PATH gets approval
NuPathe Inc. (NASDAQ: PATH) today announced that the U.S. Food and Drug Administration (FDA) has approved Zecuity(TM) (sumatriptan iontophoretic transdermal system) for the acute treatment of migraine with or without aura in adults. Zecuity is a single-use, battery-powered patch that actively delivers sumatriptan, the most widely prescribed migraine medication, through the skin. Zecuity provides relief of both migraine headache pain and migraine-related nausea (MRN).
"The approval of Zecuity represents a major milestone for NuPathe and migraine sufferers," said Armando Anido, CEO of NuPathe. "As the first and only FDA-approved migraine patch, we believe Zecuity will be a game-changing treatment option for millions of migraine patients, especially those with migraine-related nausea. We thank the patients and physicians who participated in our clinical trials as well as our employees for their support throughout the development of Zecuity. We now intensify our focus to securing commercial partners and preparing for the launch of Zecuity expected in the fourth quarter of this year."
update report HEB
WASHINGTON--A federal advisory panel said a proposed medicine from Hemispherx Biopharma Inc. (HEB) to treat chronic fatigue syndrome isn't ready for marketing after struggling Thursday to make recommendations about the product.
Hemispherx Biopharma is seeking approval from the U.S. Food and Drug Administration for a drug called Ampligen. The product, which been in development for more than two decades, was reviewed Thursday by the agency's arthritis drugs advisory panel, which is made up of non-FDA medical experts. In an 8-to-5 vote, the panel said the company didn't provide sufficient data to support the marketing of Ampligen. The vote amounts to a recommendation that FDA not approve the drug.
Several panel members said they struggled with their decisions because it appears the drug works in certain patients even if it wasn't strongly shown in the clinical data presented to the panel.
"I think the advisory panel in general hopes there will be an effective drug and hopes this might be the drug" for chronic fatigue syndrome, said Lenore Buckley, the panel's chairwoman and a professor at Yale School of Medicine. "We are interested in seeing more data."
HEB does NOT get approval
for the NDA ampligen--stock plumets after hours
Im either going to heaven or hell tomorrow---but im goin with HEB!!!!!
GERN may be lookin to close the gap????
http://stockcharts.com/h-sc/ui?s=GERN&p=D&yr=0&mn=6&dy=0&id=p37927836717
I know we play bio's here--but EXM might be worth your time and effort
http://stockcharts.com/h-sc/ui?s=EXM&p=D&yr=0&mn=6&dy=0&id=p89898095572
ISR----i hope somebody played it
http://stockcharts.com/h-sc/ui?s=ISR&p=D&yr=0&mn=6&dy=0&id=p47281709180
another beautiful day here in shangrala
NEWS---CHTP
CHARLOTTE, N.C., Dec. 4, 2012 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) today announced positive preliminary results for Study 306B, a Phase III trial evaluating the safety and efficacy of investigational drug Northera(TM) (droxidopa) for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) associated with Parkinson's Disease (PD), including achievement of the study's pre-defined, pre-specified primary endpoint.
The results showed that treatment with Northera provided clinically meaningful and statistically significant improvements compared to placebo in dizziness/lightheadedness at week 1 (1.0 unit change; p=0.018), the primary endpoint. In addition, compared to placebo, a statistically significantly greater number of patients were observed to experience 2, 3 or 4 unit improvements at week 1 compared to baseline (all p-values200mmHg. Seven percent of patients treated with Northera vs. 5% receiving placebo had measurements of supine SBP of >180mmHg. Four Northera-treated patients (4.5%) and 5 placebo-treated patients (6.1%) discontinued treatment due to hypertension.
"Data from Study 306B are consistent with the findings of 306A and other Northera clinical studies. They demonstrate an improvement in dizziness and lightheadedness and suggest a reduction in falls for patients taking Northera. In addition, Northera was well tolerated, with a relatively low incidence of supine hypertension," commented Dr. Robert A. Hauser, Professor of Neurology, Molecular Pharmacology, and Physiology, and Director of the Parkinson's Disease Movement Disorders Center, University of South Florida and principal investigator for the trial. "There is an urgent need for new therapies that help alleviate the potentially disabling symptoms of NOH and keep patients safer."
ISR---hope peeps were paying attention
INO--chart below---having a nice morning--but its gonna have to bust out some major volumn to get past resistence--we will see
http://stockcharts.com/h-sc/ui?s=INO&p=D&yr=0&mn=6&dy=0&id=p09163799209
INO--chart below---having a nice morning--but its gonna have to bust out some major volumn to get passed resistence--we will see
http://stockcharts.com/h-sc/ui?s=INO&p=D&yr=0&mn=6&dy=0&id=p09163799209
ISR----dont say you wasnt told---15% and rising
ISR chart---slow steady swing
http://stockcharts.com/h-sc/ui?s=ISR&p=D&yr=0&mn=6&dy=0&id=p97041645108
your numbers wont work--theres only 500 million in the pot--500 million people would win $1
just another beautiful day here in shangrala
CORT chart---watch out
http://stockcharts.com/h-sc/ui?s=CORT&p=D&yr=0&mn=6&dy=0&id=p63975453991
OCLR---TAKE NOTICE PEOPLE
http://stockcharts.com/h-sc/ui?s=OCLR&p=D&yr=0&mn=6&dy=0&id=p00036860150
PGNX---lookin like a winner
http://stockcharts.com/h-sc/ui?s=PGNX&p=D&yr=0&mn=6&dy=0&id=p83929895294
this one also DCTH chart below
http://stockcharts.com/h-sc/ui?s=DCTH&p=D&yr=0&mn=6&dy=0&id=p20078730381
Possible reversal ?????????? chart below
http://stockcharts.com/h-sc/ui?s=VTUS&p=D&yr=0&mn=6&dy=0&id=p93554536881
SOMX off a double bottom here
http://stockcharts.com/h-sc/ui?s=SOMX&p=D&yr=0&mn=6&dy=0&id=p48911422277
do you have a name other than this on skype??????
DIVA----
go check your Skype--if your so inclined
PS
my hair is already 2 different colors---mostly grey--what you gonna "mark " me for now???????? lol
nice to see your smiling face again !!!!!
KERX TOOK A HIT TODAY
http://stockcharts.com/h-sc/ui?s=KERX&p=D&yr=0&mn=6&dy=1&id=p32832611877
THRX---very nice news play
nice to finally find you again kiddo!!!!!!!
MDW---here it goes!!!!!!!!
http://stockcharts.com/h-sc/ui?s=MDW&p=D&yr=0&mn=6&dy=0&id=p04840146298
been trying for the last 3 hrs---guess the servers know barniy is back in town---lol
mr chipper---SKZW might be worthy of some of your attention
welcome home brother!!
http://stockcharts.com/h-sc/ui?s=SKZW&p=D&yr=0&mn=6&dy=0&id=p69903660206
Sorry for your loss---My condolences to you and yours
is the room having problems?