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Are you going to sticky this info so the whole board can read it?
$PSDV $3.50 pSivida (PSDV) Notes Alimera (ALIM) Entering ILUVIEN Labeling Discussions with FDA
pSivida Corp. (Nasdaq: PSDV) announced that its licensee Alimera Sciences (Nasdaq: ALIM) has entered into labeling discussions with the U.S. Food and Drug Administration (FDA) for ILUVIEN® for Diabetic Macular Edema (DME) and, as a result, reported its agreement with the FDA that the January 2014 Dermatologic and Ophthalmic Advisory Committee meeting to discuss ILUVIEN for DME was no longer necessary.
Alimera reported that it plans to respond to the FDA’s October 2013 Complete Response Letter (CRL) in the first quarter of 2014 and intends to address the concerns raised regarding the facility at which ILUVIEN for DME is manufactured and to provide recent safety data from patients in the United Kingdom and Germany. Alimera reported that the FDA has indicated that new clinical trials will not be required in connection with the FDA’s review of ILUVIEN for DME prior to approval.
“We are very pleased with Alimera’s discussion with the FDA with respect to appropriate labeling for ILUVIEN for DME and next steps required to move it closer to an FDA approval,” said Paul Ashton, Ph.D., President and CEO of pSivida. “We look forward to a first quarter resubmission and, hopefully, approval of this product. If approved, we will be entitled to a $25 million milestone payment from Alimera and 20% of net profits (as defined) on sales of ILUVIEN for DME by Alimera in the U.S.”
ILUVIEN is approved and commercially available in the United Kingdom and Germany and slated to launch in France early next year. ILUVIEN is also approved in Austria, Portugal and Spain and pending approval in Italy. In addition, Alimera has filed with the Medicines and Healthcare Products Regulatory Agency in the United Kingdom as the Reference Member State for ten additional European Union country approvals through the Mutual Recognition Procedure. pSivida will be entitled to 20% of net profits (as defined) on sales of ILUVIEN for DME by Alimera in the EU on a country-by-country basis.
http://bit.ly/1dP6jvv
$ATHX Athersys' MultiStem stem cell therapy receives orphan drug designation in Europe for prevention of graft-versus-host disease
Co announced that the Committee for Orphan Medicinal Products of the European Medicines Agency (:EMA) has issued a positive opinion (EMA/OD/146/13) for the Company's allogeneic, multipotent adult progenitor cell, or MultiStem therapy, for the prevention of graft-versus-host disease (GvHD). The Company is developing its MultiStem cell therapy as a GvHD prophylaxis in patients undergoing allogeneic hematopoietic stem cell transplant and is currently preparing for a Phase II/III clinical study in the area. The MultiStem therapy for the prevention of GvHD has also previously been granted orphan drug designation by the FDA.
http://yhoo.it/19aq4R8
$CYTR Thanks Kei. GLTY
Thanks again $heff for another great pick.
$CYTR wow I sold WAY too early. Oh well........
$DARA just did an offering @ .50
http://yhoo.it/1dm7Itt
Navidea Biopharma (NAVB) Lymphoseek Granted FDA 'Fast Track' Designation
Navidea Biopharmaceuticals (AMEX: NAVB) announced that the US Food and Drug Administration (FDA) has granted Fast Track designation to Lymphoseek® (technetium 99m tilmanocept) Injection for sentinel lymph node detection in patients with head and neck cancer. Under the FDA Modernization Act of 1997, the Fast Track program was designed to facilitate the development and expedite the review of drug candidates intended to treat serious or life-threatening conditions, and that demonstrate the potential to address unmet medical needs. Navidea intends to file the supplemental New Drug Application (sNDA) for Lymphoseek before year-end. Lymphoseek was approved by the FDA in March 2013 for use in lymphatic mapping procedures that are performed to help in the diagnostic evaluation of potential cancer spread for patients with breast cancer and melanoma.
“The Fast Track designation Navidea has received for Lymphoseek recognizes the significant unmet need that exists in the treatment of head and neck cancers and the important role that Lymphoseek can play in reducing or eliminating the need for debilitating elective neck dissection surgery,” said William J Regan, Navidea Senior Vice President for Global Regulatory Strategy. “After filing the sNDA, we look forward to working closely with the FDA to bring to market as quickly as possible an expanded label for Lymphoseek and what will be the first agent indicated in sentinel lymph node detection."
Lymphoseek NEO3-06 Clinical Trial Results
Navidea’s Phase 3 clinical trial (NEO3-06) of Lymphoseek was a prospective, open-label, multicenter, within-patient study of Lymphoseek® (technetium Tc 99m tilmanocept) Injection. It was designed to identify sentinel lymph nodes (SLNs) and determine the false negative rate (FNR) associated with Lymphoseek-identified SLNs relative to the pathological status of non-SLNs in head and neck and intraoral squamous cell carcinoma. The primary endpoint for the NEO3-06 trial was based on the number of subjects with pathology-positive lymph nodes (lymph nodes found to harbor cancer) following a multiple level lymph node dissection and required a minimum of 38 subjects whose lymph nodes contained pathology-confirmed disease. Of the more than 80 subjects enrolled in the NEO3-06 trial, 39 subjects were determined to have pathology-positive lymph nodes. Results demonstrated that Lymphoseek correctly identified 38 of these 39 patients, for an overall False Negative Rate (FNR) of 2.56%. This was statistically significant (p=0.0205) against the statistical threshold for success. These findings indicate that Lymphoseek accurately identified SLNs in these trial subjects, and is likely to be predictive of overall node pathology status. FNR is the rate of occurrence of negative test results in subjects known to have the disease for which the individual is being tested. Moreover, multiple level nodal dissection of patients in the trial with cancer-positive lymph nodes led to an average removal of 38 lymph nodes per patient, whereas Lymphoseek on average led to the removal of approximately 4 lymph nodes, representing a substantial reduction in potential morbidity for patients with head and neck cancer undergoing single lymph node biopsy. The study also reported no differences were observed in the ability of Lymphoseek to detect SLNs between same-day or subsequent-day surgery following Lymphoseek injection, and also evaluated the use of Lymphoseek in lymph node imaging, or lymphoscintigraphy.
http://bit.ly/1bt2ito
$PGNX Yeah I saw that pr on Schwab. Thx. GLTY
$SGLB short interest, here's the link....http://bit.ly/IM3VMf
Yeah I just got home and saw the pr on Schwab. OT... wedding anniversary, took the wife out for prime rib. Yummy.
Short data is on the $SGLB extended quotes in Ihub.
$SGLB .2395, took out .239. Next up .2689 then .276
.239 is resistance,12/3/13 it was a down day with high volume....11.6 mil
$APPY 1.99.....2.03 hod, finally moving.
$PGNX....I'm in, small position.
POZEN Inc. (POZN), a pharmaceutical company committed to transforming medicine that transforms lives, today announced that the Board of Directors has declared a special cash distribution of $1.75 per share to all stockholders of record as of the close of business on December 11, 2013, with an expected payment date of December 30, 2013.
The pr clearly states ownership as of 12/11/2013 not the price on day of pr. But at today's closing price its just 22%. The stock price would have to be $7 or less for this to apply.
http://yhoo.it/IsZrKO
POZN
A Holiday Cash-Back Bonus
On November 21, 2013, Pozen, Inc. (POZN) announced it would issue a special cash distribution of $1.75 per share to all stockholders of record as of the close of business on December 11, 2013, with an expected payment date of December 30, 2013. This distribution represents a surplus of corporate cash and is expected to be treated as a return of capital to stockholders. In the simplest terms, shareholders on December 11, 2013 will see a reduced costs basis of $1.75 per share and receive the $1.75 per share in cash on the 30th. Pozen issued the payment as a special return of capital and not a dividend so that the payment is tax free to shareholders. We expect Pozen's stock drop by roughly $1.75 per share on the record date. The payout is analogous to a stock split, only instead of getting more shares at a lower price, investors will keep their Pozen stock with a new lower costs basis and receive $1.75 per share in cash.
Based on 30.5 million shares outstanding as of October 24, 2013 (Form-10Q), the special cash distribution equates to roughly $53.4 million being returned to shareholders. As of September 30, 2013, Pozen held cash and equivalents of $89.7 million. If we forecast an operating burn in the fourth quarter of around $3.0 million, the company will still exit 2013 with approximately $31.5 million in cash. We remind investors that Pozen is entitled to $20 million in pre-commercialization milestones on PA from Sanofi-Aventis (SNY). Therefore, following PA approval - should it come in January 2014 - Pozen could be back sitting with nearly $50 million on the books by the middle of 2014. And as Pozen reduces operating burn post PA approval, we believe the company can reach cash flow positive operations based on the royalties from Vimovo and PA alone. In fact, assuming PA approval in 2014, total operating burn at Pozen, the $20 million pre-commercialization payments from Sanofi notwithstanding, should only total around $6 million. Therefore, we think Pozen can potentially look to distribute more cash to shareholders at the end of 2014.
http://bit.ly/1bhybtj
$ONTX 15.71 Onconova Therapeutics, Inc. to Present at the 25th Annual Piper Jaffray Healthcare Conference
NEWTOWN, Pa., Nov. 27, 2013 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (ONTX) a clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, today announced that Ramesh Kumar, Ph.D., President and CEO, will present at the 25th Annual Piper Jaffray Healthcare Conference in New York, NY. The presentation will take place on Wednesday, December 4th at 3:30 p.m. ET.
http://yhoo.it/18D0mEq
$ONTX 15.71 Onconova Therapeutics, Inc. to Present at the 25th Annual Piper Jaffray Healthcare Conference
NEWTOWN, Pa., Nov. 27, 2013 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (ONTX) a clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, today announced that Ramesh Kumar, Ph.D., President and CEO, will present at the 25th Annual Piper Jaffray Healthcare Conference in New York, NY. The presentation will take place on Wednesday, December 4th at 3:30 p.m. ET.
http://yhoo.it/18D0mEq
Good question.
$ETRM 1.52
EnteroMedics Announces 18 Month ReCharge Study Results
VBLOC Therapy Continues to Demonstrate Durable and Safe Weight Loss
ST. PAUL, MN--(Marketwired - Dec 3, 2013) - EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced 18 month efficacy and safety results from its 5 year ReCharge Pivotal Trial of VBLOC® vagal blocking therapy for the treatment of obesity.
Patients in the VBLOC group (n=117), achieved excess weight loss (EWL) of 25%, or 10% total body weight loss (TBL), compared to 12% EWL, or 4% TBL for sham control group patients (n=42). The 13% difference in EWL demonstrated statistical superiority over sham control (p < 0.001). In total, 54% of patients in the VBLOC group achieved at least 20% EWL and 41% achieved at least 25% EWL, compared to 26% and 17%, respectively, for the sham control group at the 18-month interval. Significantly, approximately 78% of the patients who reported for their 18-month visit remained under the clinical trial's randomized blind.
The rate of device-related serious adverse events at 18 months was 4.3% for the VBLOC group, meaningfully lower than the 12 month threshold of 15% (p < 0.0001). The safety results continued to confirm VBLOC Therapy had no adverse cardiovascular effects. Overall, a reduction in blood pressure and heart rate was observed.
"Durable weight loss over time is a critical, if challenging, goal in bariatric medicine, one that plays a significant role in achieving long-term health benefits," said Mark B. Knudson, Ph.D., EnteroMedics' President and Chief Executive Officer. "These study results, along with multi-year data from our earlier clinical trials, demonstrate durability of effect and a superior record of safety, underscoring the attractive benefit risk profile of VBLOC Therapy. If approved, VBLOC may help to address the lifelong challenges associated with obesity by offering a treatment option that supports safe, long-term weight loss and a healthy lifestyle."
http://yhoo.it/1jgkMF8
$SGLB first support was @ .247
$SGLB next support @ .215
?????????
Argyll you are correct. Some people who refuse to see this have their own agendas.
Definition of 'Private Placement'
The sale of securities to a relatively small number of select investors as a way of raising capital. Investors involved in private placements are usually large banks, mutual funds, insurance companies and pension funds. Private placement is the opposite of a public issue, in which securities are made available for sale on the open market.
7:09AM 3D Systems announces availability of its ProJet 4500 3D printer and ProJet 5500X (DDD) 75.16 : Co anniounces the immediate availability of its ProJet 4500 3D printer, the first and only continuous-tone, full-color plastic 3D printer available on the market. This category-defining 3D printer delivers ready-to-use, full-color durable plastic parts straight out of the printer for a wide range of modeling, functional prototyping and real-use products. The co also announces the immediate availability of its ProJet 5500X, a composite materials 3D printer that is based on its latest MultiJet Printing technology.
http://yhoo.it/1aqjkbs
$ACRX....buy the rumor sell the news.
UNBOOM!!!!!!
BOOM??????? LOL
"The big news to come. I read somewhere that they report the big news this year. To ensure agreement yet. Therefore, no release yet. Was Gary's interview, or to some where..?"
Do you have a link for this?
Have a Happy Thanksgiving all.
$SGLB The chart is leaning that way? Are you looking at it upside down?