Farmas USA

CELG 1h

vaya velon ... rango -4% ,,, casi nada ... pffff :(

CELG

Fuera. Me han robado la mitad. Me salgo con el 3%

CELG -10,91% las tengo ahora ...y mira que pintaba bien viéndola por debajo del -10%...para salir esta semana en even ...🤔...veremos cómo cierran , que lo mismo se gira y aquí no pasa nada ...

CELG

Celgene down 4% on extended timeline for ozanimod resubmission in U.S.

https://seekingalpha.com/news/3350279-celgene-4-percent-extended-timeline-ozanimod-resubmission-u-s

Celgene Earnings Preview

https://seekingalpha.com/article/4167411-celgene-earnings-preview

puñetero culebron ...

CELG

A metabolite will make or break Celgene's ozanimod

Celgene disclosed that the metabolite, called CC112273, was the main reason for ozanimod's efficacy. In fact, emails from the biotech to sell side analysts noted that it was responsible for about 90% of the drug's clinical activity and safety profile observed in late-stage testing

Analysts are speculating that lack of information about this metabolite is the likely cause of a Refuse to File letter issued for ozanimod's approval application. The letter determined that nonclinical and clinical pharmacology sections of the application were insufficient

Either Celgene quickly fixes up and refiles ozanimod, or it will have to collect more data, which could put resubmission off until 2019 or 2020

Food and Drug Administration explicitly said in 2016 guidance that development and marketing delays could arise if drug metabolites are found disproportionately in animal versus in-human testing. In the case of ozanimod, investigators found much higher levels of CC112273 in people treated with the drug than in animals. (Metabolites are a byproduct of the body breaking down an active ingredient like ozanimod.

A worst-case scenario would strap Celgene with one to two years of additional pre-clinical work to prove the metabolite isn't toxic. Investment bank Jefferies estimates such an outcome poses a 5-10% hit to the company's stock

https://www.biopharmadive.com/news/celgene-ozanimod-metabolite-safety-test-approval/522268/

Vosotro vendiendo y yo esperando a himcarla el diente 😉😉😉😉😉😊

HZNP

Estás a punto de verde. ¿Esperas a los 14,2x?