La parte superior de las Bandas Bollinger en diario esta en 5,76 ... ya sabemos que fuera de dichas bandas no hay oxigeno para una cotizacion. Tiene que bajar a respirar.
Bueno, velas 30 min. Preparando el grafico. Hasta los 5,52 anda que no hay trecho ...
Donde esta la esperada actualizacion del programa de la gripe?????
NVAX
Bueno, yo también prefiero que la FDA les de estas "etiquetas" que supuestamente les garantiza una relación más cercana y de colaboracióncon la FDA pero a veces me pregunto que relevancia real tienen esos fast track, breackthough therapy, y otros, títulos similares. Fíjate en CPRX hace solo unas semanas. Resulta que van presentar la NDA del Fidarpse (que además ya está aprobado en europa) y la FDA les manda un "refusal to file" porque les faltan datos (que se ha traducido en hacer un nuevo fase III). Entiendo que no sirve de mucho esa supuesta mayor interacción con la FDA para presentar una NDA decente.
Catalyst Pharmaceuticals receives a "Refusal to File" letter from the FDA regarding its New Drug Application (NDA) seeking clearance of lead product candidate, Breakthrough Therapy- and Orphan Drug-tagged Firdapse (amifampridine phosphate), for the treatment of ultra-rare diseases Lambert-Eaton syndrome and congenital myasthenic syndromes. The company completed its rolling submission in mid-December.A "Refusal to File" letter means that, after a preliminary review, the FDA has determined that the filing is incomplete and requires additional supporting information. The document does not provide comment on the acceptability of the clinical data.
no entiendo, que tiene que ver lo que estamos hablando con que una farma presente en USA algo que tiene aprobado en Europa?
he mirado sus news de un año para aca y solo veo un Orphan Drug Designation. Se me escapa algo seguro
CPRX
CPRX
Firdapse tiene breakthrough status desde agosto de 2013. Lo de comentar que está aprobado en europa es porque sabemos que por lo menos el fármaco funciona y que tienen un dossier con info a presentar ante la FDA que ha sido por lo menos suficiente para aprobar el fco en Europa...y ni por esas
Catalyst Pharmaceutical Partners Receives Breakthrough Therapy Designation From FDA for Firdapse(TM) for the Treatment of LEMS
CORAL GABLES, Fla., Aug. 27, 2013 (GLOBE NEWSWIRE) -- Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX), a specialty pharmaceutical company focused on the development and commercialization of novel prescription drugs targeting rare (orphan) neuromuscular and neurological diseases, today announced that its investigational product Firdapse™ (amifampridine phosphate) has received "Breakthrough Therapy Designation" by the U.S. Food and Drug Administration (FDA) for the symptomatic treatment of patients with Lambert-Eaton Myasthenic Syndrome (LEMS). Firdapse™ is Catalyst's investigational therapy that is being evaluated for the treatment of the debilitating symptoms associated with LEMS, including muscle weakness.
"We are very pleased to have received Breakthrough Therapy Designation for Firdapse™ and we are excited by the FDA's decision to place our product in a category that may enable expedited development and review for patients with LEMS," said Patrick McEnany, President and Chief Executive Officer of Catalyst. "With no approved or effective symptomatic treatment currently available for LEMS, Firdapse™ has the potential to be the first-line treatment option for patients with this rare condition."
Breakthrough Therapy Designation for Firdapse™ was based on clinical data from several previously published clinical trials of amifampridine (3,4-DAP) in patients with LEMS. Firdapse™ has the potential to provide significant relief of the often debilitating symptoms of the disease, including muscle weakness (e.g. difficulty walking), difficulty swallowing and talking, drooping of eyelids and facial weakness.
About Breakthrough Therapy Designation
Breakthrough Therapy Designation was enacted as part of the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA). FDASIA defines breakthrough therapy as a drug that is "intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development."
A breakthrough therapy designation conveys all of the fast track program features, as well as more intensive FDA guidance on an efficient drug development program. The FDA also has an organizational commitment to involve senior management in such guidance. The Breakthrough Therapy Designation is a distinct status from both accelerated approval and priority review, which can also be granted to the same drug if relevant criteria are met.
NVAX
Sí, la volatilidad en el mercado de opciones suele ser mayor que en el de acciones. Algo influye el hecho de que es un mercado mucho menos líquido (al menos fuera de los grandes valores).
Ok, gracias, no me remonté tanto tiempo atras.
CPRX
hice hoy lo que no ayer.
Venta en apertura a 5,78 el paquete mete-saca que lleva en 4,30 de hace unos dias . +800 pavos
DERECHOS A CERRAR EL HUECO EN 5,52 ?
NVAX
edito: eso si, la venta tambien incluia el otro paquete mete-saca que llevaba a 5,39 pero ni dios hay querido comprarmelo asi que me lo quedo por bemoles :(
Parece que va a ser así, como ha sido casi siempre, cierre de gap y luego esperemos que rebote sobre los 5,50$.
Los fast track normalmente son así, como mínimo los que yo he seguido para entrar, el gap se cierra en los días siguientes tras la euforia momentanea.
NVAX
