España
Coñoooo, no. Avísame cuando pase algo así, hombre. Este tipo de órdenes no las tengo para ejecutarse en pre o after para no chuparme las noticias de fuera de horas.
«Después de nada, o después de todo/ supe que todo no era más que nada.»
y que piensas que estoy haciendo?, termino de verlo y eso que estoy currando, suerte.
ZGNX
¿Alguien se había enterado de que el fallo de la FDA había sido positivo? Felicidades a los agraciados. Me gusta lo que leo. Volveré a meter la caña cuando dé oportunidad.
Resumen de la parte clínica:
At the end of September, we submitted a supplemental NDA for a modified formulation of Zohydro ER capsules, with abuse-deterrent properties. The new formulation has identical hydrocodone released characteristics compared to the Zohydro product approved today, when it’s used as intended it has been designed to make it difficult to manipulate the purpose of abuse by injection or nasal insufflations or snorting.
The supplemental submission has been assigned to Purdue for a target action date of the 30th January 2015. If approved, we intend to begin a transitional launch of this product in the second quarter.
We’re also continuing to characterize the products abuse-deterrent properties, towards that objective we recently obtained FDA feedback on the abuse liability study protocols, which are now being finalized for starter studies later this year and in early January. This puts us on track to submit further data to potentially support an amended product label with abuse-deterrent claims in mid-2015.
We're also continuing to characterize the products abuse-deterrent properties, towards that objective we recently obtained FDA feedback on the abuse liability study protocols, which are now being finalized for starter studies later this year and in early January. This puts us on track to submit further data to potentially support an amended product label with abuse-deterrent claims in mid-2015
we recently selected Halo Pharma as our development and manufacturing partner for future commercial supply
a new drug application submission is being targeted for the first half of 2016, which will reference the approved Zohydro NDA
we successfully concluded the chronic toxicology studies required for further clinical development of Relday. The study results support initiation of the 20 week, multi-dose clinical pharmacokinetic and safety trial.
We are now working with the U.S. based CRO for entirely initiation of this study in January. We expect to report top line data from this multi-dose study in the third quarter of 2015.
preparation work for the Brabafen phase 3 program, which we expect to begin in the second quarter of 2015. we could have results from the phase 3 trials by early 2016
«Después de nada, o después de todo/ supe que todo no era más que nada.»
Gracias, love. Grito si vuelve a dar oportunidad. <3
«Después de nada, o después de todo/ supe que todo no era más que nada.»
ZGNX
Mi lectura de la parte financiera:
combined with the expected completion of the $24 million debt transaction plus the cash from the Purdue and Teva transactions, we believe will provide us with sufficient cash run rate through the end of 2015.
Es decir, que en medio año a más tardar, dilución.
«Después de nada, o después de todo/ supe que todo no era más que nada.»
Me salí con +8,15% y +13,57% en sendos paquetes y la tengo vigilada para próximas entradas.
CYTX
Reported Q3 EPS of ($0.12), $0.05 worse than the analyst estimate of ($0.07). Revenue for the quarter came in at $1.1 million versus the consensus estimate of $3.16 million.
Bajando entrada a 0,45.
«Después de nada, o después de todo/ supe que todo no era más que nada.»
¡Felicidades! Avisa, ¡eh!
«Después de nada, o después de todo/ supe que todo no era más que nada.»
