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Javiermgv 29/06/22 18:38
Ha respondido al tema Novavax (NVAX): Un Nuevo Comienzo
Output de la reunión FDA: No anunciamos aprobación de la mejor vacuna pero cerramos un gran trato con nuestros socios y colaboradores del entramado mafioso:"The U.S. government will pay the companies Pfizer/Biontech $3.2 billion upon receipt of the first 105 million doses. Under this agreement, the U.S. government also has the option to purchase up to 195 million additional doses, bringing the total number of potential doses to 300 million."
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Javiermgv 29/06/22 16:28
Ha respondido al tema Novavax (NVAX): Un Nuevo Comienzo
Interesante ( India)A day after India's drug regulator approved Covovax for restricted emergency use in children aged 7 to 11 years, the vaccine maker Serum Institute has written to the Centre seeking its inclusion in the national COVID-19 vaccination programme in the interest of public health, official sources said on Wednesday.In a letter to the Union health ministry, Prakash Kumar Singh, Director, Government and Regulatory Affairs at Serum Institute of India (SII) stated that Covovax is highly immunogenic with more than 98 per cent seroconversion in 7 to less than 12 years age group. Also, the vaccine is safe, effective and well tolerated in this age group, an official source said.According to the letter, the firm is also receiving requests from various sections of the society pan India to make vaccine available in government and private hospitals in view of increasing COVID-19 infections."Even employees of our firm, who have relentlessly worked on this life-saving vaccine, are requesting to us to provide this life-saving vaccine for their children soon," Singh is learnt to have mentioned in the letter.
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Javiermgv 29/06/22 03:56
Ha respondido al tema Novavax (NVAX): Un Nuevo Comienzo
A mi me preocuparía si la demanda fuese mayor que la oferta pero es al revés. Y por otro lado están asociados con el mayor fabricante del mundo y está aprobada por otras agencias de primer nivel. Es todo corrupción. 
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Javiermgv 28/06/22 18:52
Ha respondido al tema Novavax (NVAX): Un Nuevo Comienzo
Novavax COVID-19 Data Presented at FDA VRBPAC Meeting Demonstrates Broad Antibody Responses to Both Prototype and Omicron-Specific VariantsNovavax prototype vaccine (NVX-CoV2373) demonstrates broad immune responses including against Omicron and other circulating variantsPre-clinical data demonstrated that boosting with Novavax' Omicron or prototype vaccine induces immune response against Omicron variants, including BA.4/5Novavax will be ready to supply Omicron-based vaccine this fall in accordance with FDA Advisory Committee recommendation
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Javiermgv 28/06/22 18:19
Ha respondido al tema Novavax (NVAX): Un Nuevo Comienzo
Otro buen resumen:Having listened to key parts of the VRPBAC. Here is some key thoughts:1) Moderna and Pfizer obviously avoided presenting BA4/5 data,l. As one member called out the Moderna BA1 candidate / bivaleny did not outperform the prototype vaccine against these newer variants- There was extensive disagreement on how to approach the next phase other than the preference is for a BA4/5 bivalent vaccine. Moderna and Pfizer will likely have to write off all the BA1 doses produced. Novavax manufacturing that is reliant on biological processes will have a few months lag if they are forced down a strain change.- The exam question on an omicron strain seemed like it was directed at the approved vaccines. As Novavax is yet to be approved or even have booster approval (amendment post EUA) there is room for a different approach to be taken.- As multiple panelists said, the Novavax data was very compelling and Glenn did an excellent job. The FDA probably felt this was left field data as they have yet to review it partly because Novavax have yet to file the booster application, but probably because they have been prioritizing the mRNAs as we all suspect- It would be ridiculous to not approve Novavax and consider using it as a universal vaccine that outperforms mRNA for antigenic drift based on the data presented today. - The last comment by Marks was that they will not delay the approval but can't disclose exactly what is going on due to trade secrets. It is obvious they still are working through a few things with Novavax, potentially related to inspecting batches of doses shipped as per normal release processes that usually happen post EUA. It is highly unusual for a regulatory authority to question dose availability as that is irrelevant.Overall, I am more convinced on the science then I was when I first invested with better and more durable efficacy the more often you boost with Novavax. While the mRNAs will always be first to market on any major variant change, the data seen today will seriously raise questions on whether the US and Europe chose the right platform. China's decision to ignore the mRNAs is starting to look like the right one. 
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Javiermgv 28/06/22 17:29
Ha respondido al tema Novavax (NVAX): Un Nuevo Comienzo
From CNBC article: "Novavax presented data showing a booster dose of its current vaccine, which targets the original virus strain, produced a strong immune response against the omicron subvariants. Dr. James Hildreth, a temporary committee member, said he was most impressed by Novavax’s data and encouraged the FDA to quickly authorize the shot for use in the U.S. However, FDA official Jerry Weir said the Novavax data hasn’t been independently verified by the agency yet."@investing-saints el mercado evoluciona a lo que pronosticabas hace muchos meses. Me he perdido con tanta info pero dan a entender que la vacuna podría ser útil como booster para la campaña de otoño , que se tiene que ir a bivalentes por la naturaleza del virus y esto entiendo que sean muy buenas noticias de cara a 2022 y especialmente 2023 en el mercado USA y mundial.
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Javiermgv 28/06/22 16:36
Ha respondido al tema Novavax (NVAX): Un Nuevo Comienzo
Hay un detalle de la call que me ha resultado llamativo desde un punto de vista comercial, independientemente de que varios doctores estén asombrados con Novavax. Y es el punto de la FDA, cuando se sale de la agenda uno de ellos y pregunta directamente a Glenn “ cuantas dosis de la original y cuando las tendríamos disponibles” lo interpreto como una confirmación informal de que la venta (FDA EUA) se va a producir de forma inminente. Es la confirmación de la venta y es la séptima y última etapa dentro de un contacto de negociación. Que Glenn estuviese a oscuras y encendiese la luz me ha resultado algo extraño, incluso informal y quizá ingenioso. Pero no se si quería lanzar un mensaje o tenia más gente alrededor asesorándole y así se daba mayor oxígeno para responder.PD. 38,5 y PCR negativo. Mañana haré doble check. 
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Javiermgv 28/06/22 13:01
Ha respondido al tema Novavax (NVAX): Un Nuevo Comienzo
Jodo…PD. Novavax dentro de las enormes cagadas ha conseguido esquivar a la FDA con aprobaciones en todo el planeta. Ahora mismo quien tiene la sartén por el mango es Novavax. Y se debe de notar en su actitud, faltaría más.
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