#20251
Re: Novavax (NVAX): Un Nuevo Comienzo
SII tiene ya decenas de millones de dosis listas. Y podría fabricar muchísimas de las que en principio va a hacer si hiciera falta (en el futuro).
SII will be the initial manufacturer. They've already made many tens of millions of doses that are waiting to be shippable. They're sitting. We've -- my team has physically gone over there and touched them.
Dice que la mayoría va a venir de SII pero en otra respuesta:
"we are expecting multiple authorizations this year. And for each of these, we are trying to allocate product, both that we have in inventory in the U.S. and Europe and South Korea and in inventory that's being built up at Serum. And that allocation process will be complicated because until we know what the -- not only what the -- when we get the authorization, but the timing of all of these different orders. And from Gavi, we need to know where they want product when and over the coming quarters and the same thing from our APAs. And so we'll be building them -- we are building inventory, and we'll be -- over the coming weeks, we'll be figuring out how to allocate those to label them for different geographies"
Se extiende un poco más en otra respuesta:
"The supplementary filings will be filed as soon as we can. I think that we've -- if you can imagine that our team has filed 9 applications, regulatory submissions and we've got a few more countries to go, that's going to consume them. But we'll get the supplements in either around the time that they're approval or just after. And I think that we're talking weeks here. I don't think we're talking months, so I don't think there's going to be much difference. Going back to your allocation, how it's going to work with Serum. Serum is going to make the bulk of the production over the next few months. We are going to allocate -- we're going to focus on COVAX and make sure that they get their allocation. It won't be 100% of our product out of there, but it will be a large portion for the first few months, and then it will shift over to our APAs in large quantities, I think, in the second and third quarter. So the first -- the next -- this quarter and next quarter, we're going to have a lot of -- our mission is to get a lot of product out to low- and middle-income countries as soon as we can get WHO EUL and Gavi, and that will take a little time. And so during -- so there'll be some time when we can ship to other countries as well. So it's a mix right now. And as these regulatory submissions get authorization, we'll see how product flows. But the scale up of the product at Serum is -- and our places is fairly dramatic. And it's not going to really make a difference what plant it comes from."
Y un dato muy importante sobre la comparabilidad del producto hecho en otras plantas y SII:
"They conducted a Phase II, Phase III study comparing a material that they manufacture with material that we manufactured, and that's part of the regulatory dossier."
Y lo de este mes es la reunión con la FDA, no el registro.
Como comentamos, el combo gripe-covid va a centrar su estrategia futura.
SII will be the initial manufacturer. They've already made many tens of millions of doses that are waiting to be shippable. They're sitting. We've -- my team has physically gone over there and touched them.
Dice que la mayoría va a venir de SII pero en otra respuesta:
"we are expecting multiple authorizations this year. And for each of these, we are trying to allocate product, both that we have in inventory in the U.S. and Europe and South Korea and in inventory that's being built up at Serum. And that allocation process will be complicated because until we know what the -- not only what the -- when we get the authorization, but the timing of all of these different orders. And from Gavi, we need to know where they want product when and over the coming quarters and the same thing from our APAs. And so we'll be building them -- we are building inventory, and we'll be -- over the coming weeks, we'll be figuring out how to allocate those to label them for different geographies"
Se extiende un poco más en otra respuesta:
"The supplementary filings will be filed as soon as we can. I think that we've -- if you can imagine that our team has filed 9 applications, regulatory submissions and we've got a few more countries to go, that's going to consume them. But we'll get the supplements in either around the time that they're approval or just after. And I think that we're talking weeks here. I don't think we're talking months, so I don't think there's going to be much difference. Going back to your allocation, how it's going to work with Serum. Serum is going to make the bulk of the production over the next few months. We are going to allocate -- we're going to focus on COVAX and make sure that they get their allocation. It won't be 100% of our product out of there, but it will be a large portion for the first few months, and then it will shift over to our APAs in large quantities, I think, in the second and third quarter. So the first -- the next -- this quarter and next quarter, we're going to have a lot of -- our mission is to get a lot of product out to low- and middle-income countries as soon as we can get WHO EUL and Gavi, and that will take a little time. And so during -- so there'll be some time when we can ship to other countries as well. So it's a mix right now. And as these regulatory submissions get authorization, we'll see how product flows. But the scale up of the product at Serum is -- and our places is fairly dramatic. And it's not going to really make a difference what plant it comes from."
Y un dato muy importante sobre la comparabilidad del producto hecho en otras plantas y SII:
"They conducted a Phase II, Phase III study comparing a material that they manufacture with material that we manufactured, and that's part of the regulatory dossier."
Y lo de este mes es la reunión con la FDA, no el registro.
Como comentamos, el combo gripe-covid va a centrar su estrategia futura.
