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Farmas USA

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#100113

Re: Farmas USA

Pues más subidas para el viernes. Si es que da igual, todo es un catalizador del verde!

Yo ya he abrazado la fe siemprealcista! :D

 

#100114

Re: Farmas USA

EDIT

Offering 4M 

De las pocas en rojo intenso durante la sesión. Algo tenía que suceder

#100116

Re: Farmas USA

Ayer me salio en el scanner de busqueda de stocks ... ACAD.  Pase del tema por ser farma pero me vuelve a salir, por si te interesa lo comento. No se si las llevas, no las llevas ... pero indicadores que insinuan brinco, todos. Hasta Vigia dice COMPRA.  Aun MACD le queda un par de dias para llegar al verde pero igual mañana se anima la cosa y se adelanta el impulso. Cada vez que el MACD se ha puesto bullish, sube el asunto 5 o 6 pavos  ( ultimas 2 subidas al menos )

Pero oye, si mañana diluye y se calza un -25% yo negare este post, eh?? :)))

edito: hay algo que se espere proximamente o incluso podria considerar un mete-saca sin eventos ?

#100117

Re: Farmas USA

ACAD

pues pa dentro! jaja

No, no la llevo, estoy un poco desconectado, a ver si investigo un poco, interesante opción! ;-)

 

#100118

Re: Farmas USA

ACAD
Que yo sepa no hay nada a corto plazo. Tienen que ampliar los datos de la fase 2 positiva de final del año pasado pero me suena que dentro de unos meses...

#100119

Re: Farmas USA

Amarin Reaches the Onset of Approximately 80% of the Target Aggregate Number of Primary Major Adverse Cardiovascular Events Within the REDUCE-IT Study

REDUCE-IT Cardiovascular Outcomes Study Remains on Schedule to Reach Onset of Target Final Primary Major Adverse Cardiovascular Event Near the End of 2017

 

BEDMINSTER, N.J., and DUBLIN, Ireland, March 16, 2017 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today the onset of approximately 80% of the target aggregate number of primary cardiovascular events within the REDUCE-IT study. This milestone has triggered preparation for a pre-specified interim efficacy and safety analysis by the study's independent Data Monitoring Committee (DMC). Amarin currently expects the independent interim analysis to be conducted before the end of the third calendar quarter of this year.

Interim Analysis Expected in Q3

The REDUCE-IT study's event rate continues to track consistently with Amarin's existing public guidance for the timing of the interim analysis and study completion. A pre-specified interim efficacy and safety analysis is designed to be conducted upon achieving approximately 80% of the target 1,612 aggregate primary major adverse cardiovascular events within the study. REDUCE-IT patients are in the process of completing a study visit over the coming months, after which additional time is required by the contract research organizations to finish collecting and preparing data for transfer to and analysis by the DMC. This data preparation and transfer process is expected to take several months as is typical for large-scale, multi-national studies, and consistent with the process for the first pre-specified interim analysis of the REDUCE-IT study, regardless of the strength of the study results. The DMC's analysis is anticipated to occur before the end of the third calendar quarter of 2017.

Amarin will remain blinded to the interim and ongoing results of the REDUCE-IT study until after the study is ready to be stopped either at the interim analysis or at the final analysis. Guidelines for the independent DMC to recommend stopping the study for overwhelming efficacy require that the study achieve statistical significance on the primary endpoint and generate robust findings on certain, pre-specified secondary outcome measures. Given the high thresholds of overwhelming efficacy required prior to a DMC recommending an early stop to a cardiovascular outcomes trial like REDUCE-IT, Amarin continues to expect that the DMC's interim analysis will result in a recommendation to continue the REDUCE-IT study as planned to completion of 100% of the target events. The efficacy requirements detailed to the DMC for early study stoppage after the 80% interim assessment are high and include robustness thresholds for underlying data that go beyond the assessment for statistical significance on the analysis of the primary endpoint after the expected completion of the study at 100% of planned events.

First Multinational Outcomes Study to Evaluate Cardiovascular Benefit of High-Dose EPA Therapy as an Add-on to Statin Therapy

Heart disease remains the number one cause of death in the United States. REDUCE-IT is the first multinational outcomes study being conducted to evaluate the cardiovascular benefits of treating patients with high cardiovascular risk who, despite having their LCL-cholesterol controlled with statin therapy, have elevated triglyceride levels. The study is designed to examine whether the demonstrated clinical effects and postulated pleiotropic cardioprotective benefits of high-dose EPA-only Vascepa therapy, when added to statin therapy, will offer improved cardiovascular outcomes for patients. The results of this important trial, if successful, could lead to improved medical care for tens of millions of patients.  

The design of the REDUCE-IT cardiovascular outcomes study was published in March 2017 in Clinical Cardiology. A copy of this publication is available at:  http://onlinelibrary.wiley.com/doi/10.1002/clc.22692/full.

Amarin believes that the REDUCE-IT study is designed for success based on extensive review of data from clinical, epidemiologic and genetic studies. Amarin estimates that results of the trial will become available to Amarin and be publicly communicated in mid-2018. This estimated timing reflects our assumptions of the time necessary to collect vital data from all patients in the study, compile the results, and subject the results to scrutiny of the independent review committees and the REDUCE-IT operational team after reaching the onset of the target final aggregate cardiovascular event in this study. The onset of the target final aggregate cardiovascular event in this study is estimated to occur near the end of 2017.

The primary endpoint of this global, double-blind study is the time to the first occurrence of a composite of major adverse cardiovascular events (MACE). Results will be compared between the Vascepa and placebo groups. The study is being conducted under a special protocol assessment (SPA) agreement with the FDA.

#100120

Re: Farmas USA

Creo que ya lo había preguntado anteriormente, y diría que alguien me respondió, pero no encuentro la respuesta...

¿Conocéis alguna web que recoja las investigaciones en marcha a partir del tipo de patología?

Por ejemplo, investigaciones sobre el alzheimer y la fase de ensayos clínicos en la que se encuentran.

 

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