Staging ::: VER CORREOS
Acceder

Farmas USA

136K respuestas
Farmas USA
86 suscriptores
Farmas USA
Página
6.336 / 17.039
#50681

Re: Farmas USA

Parecen que quieren parar la caída. Aunque más ensayos es igual a mas pasta, por lo tanto más dilución!

#50682

Re: Farmas USA

TENIAIS RAZON

Amarin Provides Update on ANCHOR Trial SPA Agreement Rescission Appeal

BEDMINSTER, NJ and DUBLIN, IRELAND -- (Marketwired) -- 09/12/14 -- Amarin Corporation plc (NASDAQ: AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today that the Office of New Drugs (OND) within the U.S. Food and Drug Administration (FDA) has denied Amarin's appeal of FDA's rescission of the ANCHOR clinical trial Special Protocol Assessment (SPA) agreement. Amarin had previously expressed that while it believes strongly in its legal, scientific and regulatory appeal arguments that it would be an uphill battle to achieve an SPA agreement reinstatement. Amarin continues to believe that reinstatement of this SPA agreement and approval of an indication based on the ANCHOR clinical trial results is in the best interest of patient care and is evaluating OND's response and potential next steps. Amarin has not yet received a determination from FDA on the pending ANCHOR supplemental new drug application (sNDA).

Vascepa remains FDA approved and marketed for use as an adjunct to diet to reduce triglyceride levels in adult patients with severe ( > 500 mg/dL) hypertriglyceridemia.

About Vascepa ® (icosapent ethyl) capsules

Vascepa® (icosapent ethyl) capsules, known in scientific literature as AMR101, is a highly-pure EPA omega-3 prescription product in a 1 gram capsule.

Indications and Usage

Vascepa (icosapent ethyl) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.
The effect of Vascepa on the risk for pancreatitis and cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined.
Important Safety Information for Vascepa

Vascepa is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to Vascepa or any of its components and should be used with caution in patients with known hypersensitivity to fish and/or shellfish.
The most common reported adverse reaction (incidence > 2% and greater than placebo) was arthralgia (2.3% for Vascepa, 1.0% for placebo).
FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM

Vascepa is under various stages of development for potential use in indications that have not been approved by the FDA. Nothing in this press release should be construed as promoting the use of Vascepa in any indication that has not been approved by the FDA.

About Amarin

Amarin Corporation plc is a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health. Amarin's product development program leverages its extensive experience in lipid science and the potential therapeutic benefits of polyunsaturated fatty acids. Vascepa® (icosapent ethyl), Amarin's first FDA approved product, is a highly -pure, EPA-only, omega-3 fatty acid product available by prescription. For more information about Vascepa visit www.vascepa.com. For more information about Amarin visit www.amarincorp.com.

Availability of other information about Amarin

Investors and others should note that we communicate with our investors and the public using our company website (www.amarincorp.com), our investor relations website (http://www.amarincorp.com/investor-splash.html), including but not limited to investor presentations and investor FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that we post on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in Amarin to review the information that we post on these channels, including our investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

Amarin contact information

Mike Farrell
Investor Relations and Corporate Communications
Amarin Corporation
In U.S.: +1 (908) 719-1315
[email protected]

Graham Morrell
Trout Group
In U.S.: +1 (646) 378-2954
[email protected]

Source: Amarin Corp. Plc

You are subscribed to Amarin Corporation plc Investor Relations' e-mail alerts as [email protected].

To update your e-mail and alert preferences, please click here.
To unsubscribe, please click here.

Amarin Corporation plc
7 Curzon St. , London, AL W1J 5HG
Service provided by Shareholder.com

#50683

Re: Farmas USA

:( Lo siento por los afectados, foreros y enfermos.

Ahora de vuelta a los 1,30 y en cuanto necesiten pasta para el Reduce-it, dilución. Yo intentaré meterme entonces.

Edito: o igual es buena idea entrar a 1,30 y confiar en que le dan el NDA. Para un metesaca bueno supongo que dará.

«Después de nada, o después de todo/ supe que todo no era más que nada.»

#50684

Re: Farmas USA

posibles entradas en 7$ 6.2x y 5$

#50685

Re: Farmas USA

Y bien que lo siento,ya vamos pillando un poco el modus operandi de estos bucaneros.
En fin,sigamos pensando en el buen hacer de la compañia,que controlen el quemado de caja y acabemos el reduce-it como se pueda,y ahi veremos que pasa,si llegamos.

Putas todas...

#50686

Re: Farmas USA

Pues no va a levantar cabeza en tiempo me temo.....habrá q ir a muy largoooo!!!
AMRN

#50687

Re: Farmas USA

Y ayer nadie sabia nada, no? Con el volumen que se negocio.... en esta mierda de accion, se filtran SIEMPRE todas noticias importantes, es de traca....

#50688

Re: Farmas USA

ALXA

-6% soy un crack! :-(