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Farmas USA

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Farmas USA
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#67170

Bi Re: Farmas USA

Vale gracias, vaya contestación . No me entiendo ni yo, pero sigo latente en mis inversiones y leyendo el foro, por que hay gente con potencial por aqui.

#67171

Re: Farmas USA

Si,yo la llevo a 4,30 desde hace unas semanas...

IMMU

#67173

Re: Farmas USA

AMRN

FILING DE LA FDA por el tema de la,demanda
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=114850349
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=114850518

por lo que leo a los usanos sus argumentos son un tanto torpes, incluso han utilizado transcripcion de lo sucedido en parte del ADCOM como argumento ... creo que eso es un error porue aquello fue una farsa y los abogados de Amarin van a tener mucho que decir al respecto ...

el tiempo dira, recordemos el 7 de Julio es la vista oral, hoy la entrega de documentacion y argumentos

AMRN

#67175

Re: Farmas USA

Veo que está a punto de liberar datos de su epratuzumab para el lupus (fase 3). Estoy pensando si entrar o no, tengo que mirar más el tema. No obstante, ¿tu como lo ves?

IMMU

#67176

Re: Farmas USA

Las DMPI, qué aburridas que son, moviendo muchos dias unos pocos miles de títulos o incluso ninguno...
Voy a tener paciencia, a ver si empieza a moverse ante la expectativa de resultados en septiembre...
En Yahoo le dan un precio objetivo de 5,27$

Safety Study of VAL-083 in Patients With Recurrent Malignant Glioma
The purpose of this Phase 1/2, open-label, single-arm study is to determine the safety and the maximal tolerated dose (MTD) of VAL-083 in patients with recurrent malignant glioma. Pharmacokinetic (PK) properties will be explored and tumor responses to treatment will be evaluated.

Estimated Enrollment: 55
Study Start Date: October 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)

Detailed Description:
Recurrent glial tumors of the brain continue to be one of the most challenging malignancies to treat. Median survival for patients with recurrent disease is approximately 6 months for glioblastoma multiforme. Bevacizumab is used for treatment of recurrent disease; however patients who fail bevacizumab do not have many treatment options.

Metastases to the brain are the most common intracranial tumors in adults and occur ten times more frequently than primary brain tumors. It is estimated that 8 - 10% of cancer patients may develop symptomatic metastatic tumors in the brain. Systemic therapy is rarely used for primary treatment of brain metastases because many tumors that metastasize to the brain are not chemosensitive or have been already heavily pretreated with potentially effective agents, and poor penetration through the blood brain barrier is an additional concern.

Dianhydrogalactitol (DAG) rapidly penetrates both the cerebrospinal fluid (CSF) and the blood-brain barrier and accumulates in brain tissue. Clinical study of DAG in patients with GBM or with progressive secondary brain tumors is warranted. Patients with secondary brain metastases were allowed to enroll into the current protocol in Cohorts 2 and 3; however, enrollment ceased with Amendment 5 and will not be continued beyond Cohort 3.

This study will utilize a standard 3 + 3 dose escalation design, until the MTD or the maximum specified dose has been reached. In Phase 2, additional patients with GBM will be treated at the MTD (or other selected optimum Phase 2 dose) to measure tumor responses to treatment.

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