Corinne Cardina: Absolutely. Thank you, Taylor. Let's talk about No. 1. So No. 1, to nobody's surprise, is Novavax. This is the largest company of the five, probably the most proven. It already had positive phase 3 results for its flu vaccine candidate called NanoFlu. It was shown to be superior to Sanofi's that is on the market. Those results came out in the spring, so definitely contributed to its run-up in 2020. It got $1.6 billion from the U.S. government to develop its COVID-19 vaccine candidate. The stock is up 2,700% in 2020, it is almost to an $8 billion market cap. Taylor, what is one green flag and one red flag for Novavax?
Taylor Carmichael: The green flag for Novavax, it's a COVID-19 stock last year. The flu vaccine helped them. But mostly I feel like it's the expectations for COVID-19 because to vaccinate successfully would be huge. There are distribution issues with vaccines that are on the market now, with Pfizer's drug and with Moderna's drug because they require the drugs to be frozen, to be kept very cold. Novavax, potentially, if the drug is approved or they get emergency use authorization, they could take a lot of market share. That has always been a bullish case that Novavax is still the smallest company among the top-tier vaccine candidates, and they have as good a shot as anybody.We're waiting on phase 3 data from the UK. If they get positive data, get like Moderna, Pfizer, over 90%. It's already had a huge run-up, and it's not going to do another 2,700% in 2021. But I'm always happy when I get a double or a triple or a quadruple. The potential is there for significant gains, but we don't have the data yet. We're waiting and it will happen this quarter in January, February, March. It's going to happen. They're going to give us the data from a phase 2 test in South Africa and Australia, and a phase 3 test in the UK.
Particularly the phase 3 one in the UK is critical for Novavax because, with that, you can probably get a EUA in the United States. Certainly, you would get approval in Europe and the rest of the world, and they have a lot of distribution agreements in place. So it's all hinging on that phase 3 trial.
It's very risky in the short term if they have bad news, it'll get hit hard, but the upside is substantial. I would argue also in the long term that Novavax is a strong buy because they do have a flu vaccine, and they do have a good program, even if they have short-term disappointment. So I think it's still a good stock to buy.
Corinne Cardina: Absolutely. So even though they do have the flu vaccine, it's acting a little bit like a binary biotech at the moment. We're waiting on that data. They've said they could combine COVID 19 and flu vaccine. But obviously, if the COVID-19 vaccine data doesn't look good, that evaporates as well.
We have two minutes left. Let me quickly ask you which you think is the best buy going into 2021, while we're here. In 2021, for the year and beyond, which one is the best?
Taylor Carmichael: *I would say Novavax and just knock on wood. I hope I don't jinx it. This is the largest of the companies on the list, but they are also in a very strong position in terms of finances, they are strong in terms of their science. I'm just a big believer in Novavax, so that would be my top take out of this group.*
The new protocols for the South Africa Phase-2 trial was published yesterday on Novavax website. The statistical plan was modified to have a single primary efficacy endpoint defined exactly the same as the UK Phase-3 trial. The old plan had two separate efficacy endpoints with a complex procedure to determine success. The new plan is much simpler, a single endpoint with required p-value less than 0.025.
Recall that the statistical plan for the UK phase-3 trial was changed to use Pocock alpha allocation for the two planned interim and final analysis instead of O'Brien-Fleming. That raised the p-value requirement to be less than 0.0155 for the interim look and made it much easier to achieve.
It appears that steps were taken to harmonize the two UK and SA trials so that these trials could be used for approval applications at both MHRA and FDA. Now we just need the data!
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Re: Novavax (NVAX): Un Nuevo Comienzo
Esperemos que asi sea Framus, a ver si hoy es verdad que vemos esa figura alcista, esos 15-20 pavos arriba nos vienen de lujo antes de news para aflojar la carga.
Bueno si estas en otros lares será por algo..Suerte
