Novavax (NVAX): Un Nuevo Comienzo

Me parece que este tio no sabe ni lo que dice. Está diciendo un montón de cosas sin sentido. Leedlo bien:On subsequent approvals, we’re expecting an application from Novavax in the very near future. I was speaking with their representative in Australia recently. They are committed to bringing forward that application.

I understand they’ve only made it in one country so far, on the best of my advice, I’m happy for that to be updated, but I’m aware of a UK application which is now being commenced. Others are expected very shortly.

Australia was named by the country as in that next round after they’ve made their initial UK and the TGA, Therapeutic Goods Administration, is ready to roll as soon as they receive the Novavax data.

Que lo esperan pronto y que solamente lo han presentado en 1 pais. Y a otros pronto. Flipante. Yo no le daria ni la más mínima importancia. Estos estan esperando aprobación en uk para aprobar ellos.

Noticias desde Corea:

On the 15th, the Ministry of Food and Drug Safety (MFDS) started to license the manufacture and sale of the US Novavax Corona 19 vaccine produced by SK Bioscience.

The Novavax vaccine is one of five vaccines that the government is planning to introduce, and was developed as a two-dose (28-day interval) regimen. Currently, the remaining four vaccines (AstraZeneca, Pfizer, Janssen, and Moderna) have already received domestic approval.

It is a 'recombinant protein' vaccine made with genetic recombination technology and is used in existing hepatitis B vaccines and cervical cancer vaccines.

The Ministry of Food and Drug Safety said, "The safety and effectiveness of the product are carefully reviewed by the submitted quality, non-clinical, clinical, and GMP data, and the safety and effectiveness of the product are reviewed through triple consultation from the Corona 19 Vaccine Safety and Efficacy Verification Advisory Group, the Central Pharmacist Review Committee, and the Final Inspection Committee. After confirming the last name, we will decide whether to grant permission.”

¿Sabemos si esta fábrica coreana exportará vacunas o se centrará principalmente en el mercado nacional? Que aplique al CMC con su propia licencia me tranquiliza un poco más. 

En principio debería poder exportar. De hecho las instalaciones están aprobadas por la EMA, aunque no creo que aún para la vacuna de NVAX.

 https://ir.novavax.com/2021-11-15-Novavax-Announces-Submission-of-Biologics-License-Application-in-South-Korea-for-Approval-of-NVX-CoV2373 

"Today's submission reflects the first BLA submission for full approval of our COVID-19 vaccine anywhere in the world, with more anticipated to follow," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "Our partnership with SK bioscience reinforces our shared commitment to global equitable access as we work together to deliver our COVID-19 vaccine, built on a proven, well-understood vaccine platform."

In collaboration with Novavax, SK bioscience initiated the rolling submission process for NVX-CoV2373 to the MFDS in April of this year. The completion of a BLA submission to the MFDS marks the final review stage for authorization of NVX-CoV2373 in Korea. 

Novavax and SK bioscience have an existing manufacturing and licensing collaboration that is intended to provide broad and equitable access to NVX-CoV2373 both in Korea and globally through the COVAX Facility. SK bioscience finalized an advance purchase agreement with the Korean government to supply 40 million doses of NVX-CoV2373 to South Korea earlier this year.

Queda Praga de las que se supone más avanzadas. Ideal que completaran los datos con esta planta antes de mitad de diciembre para poder entregar para los booster de esta campaña en Europa. Muy justo me parece pero a ver ...

Y aquí parece el permiso para exportar de India las primeras dosis, 50M:

https://m.timesofindia.com/india/govt-allows-sii-to-export-5-crore-doses-of-covid-19-vaccine-covovax-to-indonesia/articleshow/87719550.cms

Muy buenas Novaverox,vamos con previsiones para hoy.
 sin mas ruido  ni de noticias ni de nada de nada  solo con estudio y lo que el precio nos comunica con su movimiento .
V amos con ese escenario previsto para hoy.

CUAL SERIA Lechu?

Pues amigos en principio muy clarito seguimos con escenario del ultimo dia lo mismo mismo zonas a confirmar su rotura y sobre todo cierres del dia 168-175 en este momento y los demas odjetivoa por arriba y por debajo los espuesto en ultimo comentarios de semana pasada.
Franja grisacea del centro zona importantisima cada dia su rotura y ojo CONFIRMACION Con cierta fuerza por encima garantizara siguientes odjetivos tanto de arriba como de abajo.
Pasar una buena tardes y mejor operativa con NVAX
Un abrazo grande para todos.

ZONAS CLATRA ,A SUPERAR O PERFORAR LOS 168-175 Aprox SU ROTURA POR ENCIMA DE LOS 175 Y CONFIRMACION  O POR DEBAJO DE LOS 168 Y CONFIRMACION ODJETIVOS SIGUIENTES DEPENDIENDO DE POR DONDE SALGA EL PRECIO DESPUES DE VACILAR TANTOS DIAS YA

NEW DELHI : The Indian government has permitted export of 5 crore doses of Covovax, a COVID-19 vaccine domestically produced here by the Serum Institute of India (SII), as the jab has not yet been approved for emergency use in the country, official sources said on Monday.

The drug major SII has been allowed to export 50 lakh vials, equivalent to 5 crore doses, of Covovax to Indonesia, they said.

NEW: UK's definition of a fully-vaccinated person will change to account for booster shots, PM Johnson says - REU

Pinchamos en premarket ... genial ... no se que ruido sobre PFIZER, no he querido ni leerlo...
Por cierto, la MM10 por arriba en los 174,7 .... la MM20 diaria en 159,8 por abajo.


edito: creo que es esto:
Pfizer firma acuerdo para ceder la patente de su píldora contra COVID-19

Si, nada que tenga que ver con nosotros, pero así es el juego