España
Winner, un %? pides mucho, compañero. Esto es muy complejo.
Lee todo lo que te sea posible de lo que hemos ido subiendo. Te formara una opinion.
:)
edito: 10 panelistas, 2 cardiologos con elevadas probabilidades de decir que no. 5 endocrinos con elevadas probabilidades de decir que si. El resto a saber.
Oye Will! Que planes tienes para el Miercoles?
pues nada, me levantare, me tomare unas tostadas y un coffee y luego me pasare por el adcom a leer a la FDA unas cuantas cosillas que he preparado para que no las pasen por alto ... luego quizas me tome una cañita con los de Amarin ...
LO FLIPO.
Grande Ana!
Cappello está ocupado con los twitts.
Joer chicos que nivelazo, codeandose con los grandes. .....salga como salga la acción mucha gente os estará agradecida, moscas cojoneras a parte.pedazo de hilo. Saludos.
Reglamento del SPA
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080571.pdf
Página 9, apartado B
( hago traduccion no literal )
CAMBIOS EN LA DOCUMENTACION DEL SPA
Tal y como se establece en el acuerdo SPA, habiendo acordado el diseño, ejecucion y analisis propuestos en los protocolos revisados bajo este proceso [....], la Agencia no alterara posteriormente su perspectiva sobre los temas de diseño, ejecucion o analisis a menos que sean evidentes preocupaciones sobre la salud publica que no fueron reconocidas en la fecha de valoracion del protocolo.
Las valoraciones documentadas de este protocolo especial deben ser de obligado cumplimiento por la division de revision y no deberian ser modificadas en ningun momento, salvo que:
1.- el sponsor (Amarin) no siguiera el protocolo acordado y la division de revision no se vera ya obligada a cumplirlo.
2.- si el sponsor suministrara datos relevantes que posteriormente fueran encontrados falsos, erroneos o no hubieran sido suministrados datos para omitir hechos relevantes.
3.- el documento del SPA puede ser modificado si el sponsor tambien esta de acuerdo y dicha modificacion se realiza con el objeto de mejorar el estudio.
Un protocolo especial modificado de este modo sera considerado de obligado cumplimiento por la division revisora salvo en el caso que :
4.- el director de la division revisora determine que aspectos cientificos substanciales esenciales para determinar la seguridad o eficacia del farmaco han sido identificados despues de haberse iniciado el estudio . Si esto fuera asi la administracion documentaria el caso y se lo comunicaria al sponsor y el sponsor dispondria de la oportunidad de una reunion en la que se discutira el asunto cientifico con el director de la division revisora . Esta reunion sera de Tipo A bajo los objetivos de la PDUFA en la gestion de reuniones.
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Ahora vosotros me direis qué de todo esto es aplicable al caso que nos ocupa y por lo que la FDA, independientemente del ADCOM, no debiera hacer honor al acuerdo SPA. Yo aqui no veo que sea aplicable ninguno de los supuestos 1,2,3,4.
Y sobre la salud publica,
Acaso se han descubierto nuevas preocupaciones sobre la salud publica que no estuvieran ya contempladas cuando se diseño el trial Anchor?
Ahi lo dejo, ya direis ...
Bueno, bueno ... los cracks andan ya con humor frikki .... modo desvario on :))))
Interesante artículo d Redacre investments. Recomendación d opciones puts para los q vamos largos.
http://www.redacre.com/weekly-review#.UltO52uHVIs.twitter
AMRN
Cellceutix Drug Brilacidin™ May Be The Key Antibiotic on the Horizon for Serious Skin Infections; Plans to Start Phase 2b Study in January 2014
Antimicrobial resistance is one of our most serious health threats states Centers for Disease Control. Declares Urgency for New Antibiotic Drugs.
Beverly, MA -- 10/14/13 -- Cellceutix Corporation (OTCQB: CTIX) (the "Company"), a clinical stage biopharmaceutical company focused on discovering, developing and commercializing drugs to treat unmet medical conditions, is pleased to announce that the Company is completing the required documentation to begin a Phase 2b clinical trial of Brilacidin as a new drug candidate for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI.
Based upon what Cellceutix can only describe as exceptional results in a completed Phase 2a trial and building upon guidance from prior meetings regarding Brilacidin with the Division of Anti-Infective Products of the U.S. Food and Drug Administration, Cellceutix is planning to advance the clinical development of Brilacidin in a Phase 2b dose-optimization clinical trial. The trial will include a single-dose regimen as well as a three-day dosing regimen using Brilacidin for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by Staphylococcus aureus (including MRSA) and Streptococcus pyogenes. Cellceutix believes that, based upon consultation, the trial will begin in January 2014.
In September, the Centers for Disease Control and Prevention (“CDC”) released a report, entitled, “Antibiotic Resistance Threats in the United States, 2013.” Specifically, the report stated “Antimicrobial resistance is one of our most serious health threats” as part of an analysis of the “potentially catastrophic consequences of inaction” in a growing epidemic where resistance to current antibiotics is leaving few options that are generally less effective and more expensive. Cellceutix is diligently working to commence the Brilacidin Phase 2b trial as well as exploring accelerated approval programs available with the FDA to meeting this area of great unmet medical need.
“More than two million Americans acquire serious bacterial infections annually. The CDC has made it clear as to how critical it is to develop new therapies to address this fact, which has recently been highlighted by news of National Football League and NFL Players Association acknowledging a problem with MRSA infections.” said Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. “Brilacidin is the first of an entirely new class of antibiotics, known as defensin-mimetics. It can rapidly kill the bacteria that cause ABBBSI, including resistant strains of Staph aureus, such as MRSA. Also, unlike most antibiotics, Brilacidin has minimal potential to promote the further development of resistant strains. This is because of its unique mechanism of action, as well as its ability to be given as a short course regimen, perhaps as a single dose. Both single and 3-day dosing regimens will be explored in the upcoming phase 2b study. Single-dose therapy removes patient non-adherence as a driver of antimicrobial resistance, and it allows for reduced health care costs, as patients do not need to return to the clinic or hospital for additional doses.”
Dr. Menon added, “Brilacidin could be the key antibiotic on the horizon for serious skin infections. Based on sales of antibiotic compounds and recent billion-dollar acquisitions that reflect the value of new antibiotics, we are very excited and believe that an FDA approved Brilacidin would capture a significant share of the ABSSSI market, due to its unique attributes, including short-course therapy. With ABSSSI as the lead indication, followed by other possible uses for infected wounds, bone, joint and blood stream infections, Brilacidin could fill a large void in the dwindling global portfolio of effective antibiotics. Our strategy includes capitalizing on the Generating Antibiotics Incentives Now (GAIN) Act, which, combined with other government efforts, is positively changing the regulatory climate in the developmental of drugs like Brilacidin.”
About Cellceutix
Headquartered in Beverly, Massachusetts, Cellceutix is a publicly traded company under the symbol "CTIX". Cellceutix is a clinical stage biopharmaceutical company focused on developing and commercializing its pipeline of compounds for novel therapies in areas of serious unmet medical need, including cancer, psoriasis and antibiotic applications. More information is available on the Cellceutix web site at www.cellceutix.com.
Safe Harbor Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, including statements as to revenue projections, business strategy, outlook, objectives, future milestones, plans, intentions, goals, future financial conditions, future collaboration agreements, the success of the Company's development, events conditioned on stockholder or other approval, or otherwise as to future events, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements contained in this release are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Factors that may impact Cellceutix's success are more fully disclosed in Cellceutix's most recent public filings with the U.S. Securities and Exchange Commission.
