SAN RAMON, Calif., June 29, 2016 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc. (GALE), a biopharmaceutical company committed to the development and commercialization of targeted oncology therapeutics that address major unmet medical needs, today announced the recommendation from the Independent Data Monitoring Committee (IDMC) on the interim analysis for Galena’s NeuVax™ (nelipepimut-S) Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) clinical trial. On June 27, 2016, the IDMC recommended that the PRESENT trial be stopped due to futility. The letter is attached to the Form 8-K filed today and available on the Company’s website. This planned safety and futility interim analysis was triggered after 70 qualifying disease free survival (DFS) events were reached, and a total of 71 events were reviewed by the IDMC.
“We are extremely disappointed with the outcome of the PRESENT futility analysis,” said Mark W. Schwartz, Ph.D., President and Chief Executive Officer. “On behalf of our entire company, I would like to thank all of the courageous patients and their families, investigators, study staff and independent committees who participated in the PRESENT study. To date, the trial has not been un-blinded other than by the IDMC, and we need to evaluate the data. We expect to host a conference call next week to provide a preliminary review of the PRESENT trial and an update on all of our immunotherapy and hematology clinical development
You are so wrong. They make them all the time. Here is a decision that was made today on Titan
In both phase 3 studies (Study-00, 1346 patients; Study-03, 1337 patients), plecanatide treatment showed statistically significant improvement from baseline in Bristol Stool Form Scale (BSFS) scores compared to placebo, bringing mean stool consistency scores to a normal physiological value (BSFS = 4).
Synergy Pharmaceuticals Inc. (SGYP) today announced additional data from two pivotal phase 3 clinical trials (Study-00 and Study-03) evaluating the efficacy and safety of plecanatide, a once-daily oral tablet, in treating patients with chronic idiopathic constipation (CIC). Data were presented at Digestive Disease Week (DDW) in San Diego.
The primary endpoint for both pivotal trials was the durable overall complete spontaneous bowel movement (CSBM) responder endpoint, as defined by the U.S. Food and Drug Administration (FDA). As previously disclosed, both plecanatide 3 mg and 6 mg doses met the primary endpoint and demonstrated statistical significance in the proportion of patients in the intention-to-treat population who were durable overall CSBM responders compared to placebo during the 12-week treatment period (21.0% in 3 mg and 19.5% in 6 mg dose groups compared to 10.2% in the placebo group; p
Here was my reply back from them but I did not use all the great questions posted here.
Dear Mr. Ritz,
Thank you for writing to the Division of Drug Information in the FDA's Center for Drug Evaluation and Research.
FDA cannot comment on drugs or indications in development, in the FDA review process, or that have been denied approval by FDA. FDA is empowered to approve drug products that have been shown to be safe and effective for their labeled use, and we can provide releasable information on products approved for use only in the United States. Please understand that information about unapproved drugs/drugs in development is confidential according to 21 CFR 314.430, and belongs to the manufacturer/sponsor developing the drug, so we cannot provide it to the public.
Listed below are some Internet sites that may be useful to you. Some are other government agencies, while others are private. Please be aware that the FDA does not endorse any of the information contained on the non-government sites:
Clinical Trials Information:
Drug Information Specialist
Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration
Reconstitution of the Board
As previously reported on a Form 8-K filed by ARIAD Pharmaceuticals, Inc. (the "Company") with the SEC on March 14, 2016, in order to facilitate the Company's evaluation of its Board of Directors (the "Board"), each of the Company's directors tendered conditional resignations from the Board. On May 19, 2016, the Board accepted the resignations of Jay R. LaMarche, Thanassis Lavidas, Massimo Radaelli and Wayne Wilson, to become effective immediately prior to the Company's 2016 annual stockholders meeting to be held on July 21, 2016 (the "2016 Annual Meeting").
The information set forth in Item 5.03 of this Current Report on Form 8-K is incorporated by reference into this Item 5.02.
As stated by ME777, Paid Prescriptions UP by More than 31 % - Hospital Prescriptions Up by More than 43% - Only Free Prescriptions are down by less than 5% - Overall the numbers are trending UP.
This is no big deal. Even I own 33k shares. Now if he was like Dr Frost from OPK buying 12 million shares over the last year that would be a great sign of things to come. This is a $14 stock at best.