Sentences with phrase «pivotal trial»
The phrase "pivotal trial" refers to a very important and influential study or experiment. It is a crucial test that can determine the success or failure of a new product, treatment, or idea. The results of a pivotal trial have a significant impact on whether something will be approved, implemented, or widely accepted. Full definition
Strong results from the other arm of CoreValve's U.S. Pivotal Trial with patients at extreme risk for standard aortic valve - replacement surgery were reported in October and led to Food and Drug Administration approval for the device in this population.
sciencedaily.com
«The first year results from the CoreValve US Pivotal Trial support the safety and efficacy of this therapy in patients unsuitable for surgical aortic valve replacement,» said lead investigator Steven Yakubov, MD..
If Endocyte can get this candidate to produce pivotal trial results that fall in line with previous observations, the $ 12 million it paid to license Lu - PSMA - 617 last year could go down as the greatest biopharma investment of the century.
Once data from ongoing pivotal trials start rolling in, BeiGene stock could soar much further.
Damiano and Russell are working with Xeris Pharmaceuticals to get approval for a version of glucagon that can last for months, and it will be tested for FDA approval in their upcoming pivotal trial.
In January 2014, Medtronic announced that it was halting its U.S. pivotal trial on renal denervation because the study had failed to reach its primary efficacy endpoint, though it did meet its primary safety endpoint.
«Off Topic: ABA Chronicles 10 Pivotal Trials Main Quantum Meruit: Discharged Contingency Attorneys Entitled To Quantum Meruit Recovery, Not Pro Rata Distribution Where Contingency Award Could Satisfy All Fee Claims»
An expert witness in a pivotal trial in Vancouver told the court that...
Revenue from selling Celgene's therapies will fund the company's late - stage pipeline, which boasts three new cancer therapy candidates in pivotal trials.
2018 will see data readouts on eight phase 3 trials, initiation of eight other phase 3 or pivotal trials, and several New Drug Application submissions.
Endocyte will begin a pivotal trial in the second quarter, and the outcome is far from certain.
In an interview in the spring of 2015, Damiano confidently predicted: «We're going to be running a pivotal trial by the end of the year,» referring to the type of clinical trial designed specifically to meet the FDA's standards for getting a device approved.
Mazlish and Brewer fully understand they will need to complete a pivotal trial involving hundreds of people with Type 1 to gain FDA approval for their device.
Rather than beginning his pivotal trial by the end of last year, he now predicts it won't start until spring 2017 and won't be completed until that year's end.
Like Damiano and Russell, Bigfoot has been pushing back the projected date for its pivotal trial.
«We're the only ones in a pivotal trial.
The pivotal trial for US regulatory approval is ongoing and is set to enroll around 150 patients in the US and Europe.
They analyzed the association between body mass index (weight divided by height) and progression - free survival (PFS) and overall survival (OS) in six independent cohorts of patients treated with targeted therapy, immunotherapy or chemotherapy in pivotal trials that led to FDA approval of these drugs.
This pivotal trial is the largest study conducted of renal artery denervation as a treatment for resistant hypertension and the most rigorously designed, including blinding and a sham treatment in the control arm.
Findings of reduced drinking, relapse, and improved mood and sleep with gabapentin in recently abstinent alcoholics by the Mason lab has lead to a pivotal trial in support of FDA approval for a long acting form of gabapentin (gabapentin enacarbil, Horizont) as a new treatment for alcohol use disorder.
A Pivotal Trial of ARQ 087 in Subjects with FGFR2 Gene Fusion Positive Inoperable or Advanced Intrahepatic Cholangiocarcinoma
Results of this trial is a big deal, because it is a pivotal trial, data from which will be used for BLA submission to FDA and market approval.
With good clinical results in treatment of genetic eye diseases (inherited retinal dystrophies) and Breakthrough Therapy Designation by FDA, the company rapidly progressed to Phase 3 pivotal trial.
We are currently completing preclinical work required by regulators and plan to begin the pivotal trials in the U.S. and Europe in the first quarter of 2018.
Ross» research indicates that a typical «pivotal trial» on which the FDA bases its drug approval decisions includes an average of 760 patients.
As part of his clinical work, Tony has served as investigator on oncology clinical trials including 2 pivotal trials.