Acceder

Novavax (NVAX): Un Nuevo Comienzo

33,7K respuestas
Novavax (NVAX): Un Nuevo Comienzo
82 suscriptores
Novavax (NVAX): Un Nuevo Comienzo
Página
810 / 2.284
#12136

Re: Novavax (NVAX): Un Nuevo Comienzo

Para los que hace poco que estais por aquí y que alguien me corrija, pero esta pájara sólo sube de verdad:
-Rumores que nos transcienden más tarde, si veis que un dia sube un 20% y no sabemos porqué es muy probable que al final de sesión se publiquen datos nuevos que hacen que el día después se dispare.
-Fases completadas con éxito.
-Inyección de fondos por alguna entidad como CEPI, Bill Gates o BARDA(esta aun no he pillado ninguna)
Cuando no consolida subida:
-Noticia de que ha comprado un laboratorio para producción en masa (es una inversión y no una entrada de dinero)
-Como hoy , un pedido futurible pero en base a la espera del éxito de las fases y en este caso los cortos se hinchan calentando antes el premarket
En el gráfico vereis que ha hecho un touch and go del canal descendiente del cual @framus-morrigan se reía antes de los 70...



#12138

Re: Novavax (NVAX): Un Nuevo Comienzo

#12139

Re: Novavax (NVAX): Un Nuevo Comienzo

El acuerdo con el ministerio de defensa me gusta y mucho. Apostaba fuerte porque cerraría el gap pero.... mondo difficile!  Aquí en diario si respeta el canal bajista actual y dibuja el asa con las diferentes fechas en cruce de niveles Fibo. Simplemente los pongo, porque ha respetado y mucho diferentes niveles estos días atrás.

El retroceso que genera la taza es a un 1/3 de la subida, ya habría hecho el pull back.
#12140

Re: Novavax (NVAX): Un Nuevo Comienzo

En IV hay un mensaje más que relevante de redplate. 

https://www.investorvillage.com/smbd.asp?mb=193&mn=82120&pt=msg&mid=20777636

Larry Corey Currently presenting

Listening in to a Fred Hutchison in house presentation on CoViD vaccine with Larry Corey and John Mascola discussing the structure of ph 2/3 studies. Extensive details on companies and technologies and timelines. So some excellent Questions/comments.
First question was What companies-technologies are coming as Along And first company mentioned in the presentation was Novavax. First. Detailed discussions following were suggesting multiple technologies are needed to deliver seven billion doses. But he mentioned protein vaccines several times and adjuvant/proteins to target populations. He indicated children, pregnant woman and elderly are most likely targeted best By adjuvant/protein formulations.
Next
‘what are the five? Answer is that there are in fact a named five, but more are coming soon. And ‘expected BARDA Funding others as soon as they reach a certain stage. (Sounds like post ph1).
Timelines
First ph3 starts in a month, others follow, suggested protein vaccines come a few months after MRNA, and specifically mentioned protein vaccine into efficacy ph3 ‘by fall/September. He then gave timelines on potential first efficacy read out by Year end. Doubted potential for a true efficacy read out. Second ph3 (adeno) reads out next and then protein after that ( 3 months staggered finish line). But the hope is to see surrogates of immunity (antibody titer) from the sum of each study. If the MRNA trial shows immunity is seen at or above a neutralizing titer of X, then When later trials to come along like protein based Vaccines (his words) then approval could be based by immunogenicity testing. Bingo right there is the bingo.

So protein adjuvant based formulations were mentioned many many times. Including ‘we know how to make these in large quantities and they can Definitely be used in campaigns like this.’we don’t know yet if these earlier technologies will do this.

So Larry is leading the network (It is worldwide not just US) just like he did the HTVN. The group there from infectious diseases, HTVN, the statistics group are leading the study design and data collection. really great hour of detailed discussions that made me believe the right product wins in the end

Y una explicación más extensa de otro forero:

RedPlate gave you a great explanation. I know you're capable of understanding his reply, but allow me to provide some details in a language easily understood by people unfamiliar with technical jargon.

The vaccine must induce a certain amount/quality of antibodies for the vaccinated person to be protected against COVID. This amount/quality is loosely called Surrogate Of Immunity (SOI). We don't know the SOI yet because COVID is brand new.

Moderna is going to do phase II/III, in which people are vaccinated, a bunch of days later blood is tested to determine the amount of antibodies induced by the vaccine, and then the people who got later infected are identified to see who was adequately protected by the antibodies and who wasn't.

If all the protected people had antibodies above a certain level, and all the unprotected people had antibodies below that (same) certain level, and if on top of that the number of protected people is NOT ridiculously too small compared to the number of unprotected people, then we could conclude that this certain level of antibodies is the SOI (the amount/quality of antibodies required to protect against COVID).

Then, when Novavax does its phase II/III, they won't have to go to the same length Moderna will have to go through to prove efficacy. After vaccinating people and testing their blood a bunch of days later to determine the antibody levels, Moderna will have to wait several days and weeks until people are infected before efficacy can be determined.

Whereas, Novavax would only need to vaccinate and check the antibodies a bunch of days later. That's it. If the antibodies of a participant are above the SOI determined by Moderna's study, then this person is deemed protected.

However, if in Moderna's study only a tiny insignificant number of people were protected from infections, then the study would be useless, and any calculated SOI would be dismissed. Obviously, NVAX would have no SOI value to use. In that case, perhaps AstraZeneca/Oxford could come up with a valid SOI when they do their phase II/III shortly after Moderna. Then, Novavax could use the SOI determined by them. Otherwise, Novavax will have to do a longer study to determine efficacy.
#12141

Re: Novavax (NVAX): Un Nuevo Comienzo

En realidad, las fases 2 y 3 son en esencia  lo mismo, su diferencia fundamental es el número de pacientes del ensayo. Y parece que, en estas circunstancias de necesidad se van a hacer fases 2 muy amplias, con miles de pacientes, para tener datos amplios desde el punto de vista estadístico. En todas y cada una de las fases se miden los efectos secundarios porque lo mas importante en cualquier vacuna ( o en cualquier fármaco) es la seguridad. 
En cualquier caso,  la incidencia del Covid19, condicionará, sin duda alguna, los datos de los diferentes ensayos. Por eso  sera importante hacerlo en zonas con niveles de contagio elevado. Novavax, si no me equivoco, se plantea una fase 2 muy amplia y muy distribuida por países.
Hay que tener en cuenta que en esta ¨nueva normalidad" que vivimos en todo el mundo con medidas de distanciamiento, el uso de mascarillas,  test masivos (menos en España, que aquí optamos con borrar muertos delas estadísticas...) y otras medidas ayudan a la contención del virus.
Creo que en USA pretenden hacer un enorme ensayo conjunto con diferentes vacunas, que permita un estudio comparativo de las mismas ademas de medir la efectividad y la seguridad. Y pienso que si los datos de Novavax en la Fase 1 son buenos estará en dicho ensayo.
#12142

Re: Novavax (NVAX): Un Nuevo Comienzo

Joder Investing. no me había paseado por Investor Village desde ayer y no lo había leído, pero me parece brutal para Novavax. El retraso temporal que lleva frente a Moderna o la vacuna de la Universidad de Oxford  puede jugar a su favor en términos comparativos. 
Partimos de la premisa inicial de que la necesidad de una vacuna es básica y hay que acortar los plazos al máximo, siempre con la mas elevada seguridad. Básicamente lo que dice es que si las vacunas de Moderna o la U de Oxford muestran una mínima eficacia con un determinado nivel de anticuerpos, (ese SOI (Surrogate Of Immunity) Novavax  podría ver aprobada su vacuna si los análisis de los sujetos que han recibido su vacuna tienen niveles de anticuerpos por encima de los niveles las vacunas de Moderna o la U de Oxford. 
Es decir, la idea es algo similar al estudio comparativo del NanoFlu con el Fluzone en la Fase 3. Si una vacuna ha demostrado ser efectiva con unos determinados niveles de anticuerpos, cualquier vacuna con niveles de anticuerpos similares o mas elevados también debería ser efectiva.
Insisto que eso sería brutal para Novavax porque su vacuna con el Matrix ya ha demostrado en los ensayos con animales que genera mayos protección que las de Moderna o la U de Oxford.



#12143

Re: Novavax (NVAX): Un Nuevo Comienzo

“Stan Is Da Man” 😂😬😂
Desde luego que en los últimos meses está ganándose su sueldo.
Yo siempre he dicho que si es el responsable de lo negativo también ha de serlo de lo positivo.
Y aunque a muchos les joda, si hoy estamos aquí es por todas y cada una de las decisiones que ha tomado, las peores, las malas, las buenas y las mejores. 
#12145

Re: Novavax (NVAX): Un Nuevo Comienzo

una pregunta de novato......novavax dará alguna noticia de como van sus ensayos antes de julio ?
seguro que los que lleváis mucho tiempo siguiendo farmacéuticas y mas concretamente de esta, sabréis mejor que pasos van dando
gracias de antemano por la información. 
#12146

Re: Novavax (NVAX): Un Nuevo Comienzo

La historia se repite?
#12147

Re: Novavax (NVAX): Un Nuevo Comienzo

No creo que digan mucho, y aunque lo hagan no será significativo. Salvo que haya algún problema y tengan que detener el estudio, claro.

Aproximadamente la segunda semana de julio podrán tener datos de seguridad. Un par de semanas después los análisis de laboratorio. En palabras de redplate:

Sounds about right, a dozen per day per site now all have received their first shot. Add 35 days from today for last blood draw to be tested (July 10th). Lab results come a couple weeks later, but Primary safety will be done on day 35. As soon as the safety data is submitted than can be permitted for ph2.

Esas son las fechas a vigilar muy de cerca.

--

Presentación de NVAX:  https://novavax.com/NovavaxCorpPresentation-20200602.pdf 

--

Sobre lo que puse el otro día de la conferencia que vio red:

Corey (el que la dio con Mascola) is a member of ACTIV, the group that will be orchestrating/overseeing the P3s, the shared-control, the whole bit. 

THIS paper, Corey 1st author. Then Mascola, Fauci, Collins edit
https://science.sciencemag.org/content/368/6494/948 
You have Corey saying what red said at The Hutch and frikin take that to the bank.

I think the plan is to feed NVAX into the at risk elderly, pregnant, children.

Es decir, es uno de los que cortan el bacalao y que deciden.

https://www.fredhutch.org/en/news/center-news/2020/06/dr--larry-corey-at-the-center-of-covid-19-vaccine-research.html 

Más de red sobre Corey:

Larry is a legend.

Ex president Fred Hutch and head infectious diseases. Head of worldwide HIV vaccine testing network. Founder of Juno. My wife’s old boss and a long time colleague in the Seattle vaccine community. He wrote the CoViD vaccine trial proposal paper in Science last week with Fauci, Francis Collins And others. He is a really driven guy with a heart of gold. But don’t fuck up in his lab.

One of the great vaccine scientists of our time. That’s who Larry is. Long time herpes guy too. But mostly known for his pioneering work in immunology, as applied to viruses or to cancer. 

Sobre los estudios (red):

If any of the products does induce enough antibody to protect, say 50% reach it. Then it is possible we get in to ‘booster’ studies to get higher titers. Some vaccines are three shots over a year or two for children (tetanus/diphtheria) to reach ‘long term immune status. Thus it may become a ‘boost until you reach xx level of antibody.

Next is that we may see pooled data from MRNA and AZ and NVAX to see the surrogate. Say neutralizing titers of >1/64 are seen in 40% of MRNA pts and 60% of AZ pts and those two groups together now have the stats power to prove that >1/64 is ‘immune to infection’. Then NVAX comes in with 80% at >1/64, then immediate EUA is anticipated.

Some discussions about manufacturing and distribution were practical limitations of what we can manufacture when you need to vaccinate 7B people. And that was why there will be 2,3,4 different vaccines of different types approved. They are made in separate factories that don’t compete for the limited space. They want more than one technology to work. But the comments most important were ‘we know how to make protein vaccines in very large quantities we know we can do that’

That and discussed at risk groups that protein vaccines are preferred for, elderly (think nanoflu) and pregnant (think maternal RSV) and the safety and immunogenicity data generated by NVAX in these populations is looming large over the EXPECTATIONS that NVAX will be used preferably in these groups. It sounds like they are already giving us old guys (and healthy pregnant woman) to NVAX. MRNA and AZ will be fighting it out for ‘healthy adults’ . It seems children were in the at risk group as well, but also mentioned in childhood vaccine hidtory we do use some Attenuated viral types. But we shall see. So expect distinct approvals by age groups. And NVAX ( and GSK if they ever get their dinosaur ass in gear. (I lasted about 2 months as VP under the GSK banner after the buyout, just saw enough of their internal mechanisms to know I couldn’t work that slow and be happy). But first approval in elderly market I’m at >90% chance that’s NVAX.
-
It’s fine not to create any linear predictive % protective, but to show the potential protection if the immune response reaches a certain level of activity. But those numbers will not be hard numbers either. In other words if a 1/128 neutralizing titer is 100% protection , 1/64 could still be 75% or just 25%. There are other considerations as our innate immune systems kick in a lot of the protection, and that to varies in strength from person to person. However in the end a surrogate will be set at a number where ‘most’ are protected (80%?90%?) and that will become a goal post for emergency use authorization using ‘immunogenicity’ as the primary endpoint instead of a true field test for viral efficacy. It will be done like flu is in other words. The primates are supportive data to the surrogates yeti be determined in human field studies.
#12148

Re: Novavax (NVAX): Un Nuevo Comienzo

A mí aún me debe un pastizal, si me lo devuelve algún día pensaré mejor de su labor XD.
#12149

Re: Novavax (NVAX): Un Nuevo Comienzo

Como la veis? Esta semana podría dar entrada a finales? 
#12150

Re: Novavax (NVAX): Un Nuevo Comienzo

GAITHERSBURG, Md., June 08, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that Gregory M. Glenn, M.D., President of Research and Development, will join other vaccine industry leaders for a panel discussion at 2020 BIO Digital. Taking place on Tuesday, June 9 at 11:30 a.m. EDT, the panel will discuss COVID-19 vaccines. The conversation will consider the complex path from lab to clinical trials, the impact of the evolving science on candidate development and consider how collaboration will bring life-saving vaccines to the world.


Details for the panel are as follows:

Title: |   | “ Leveraging Platforms and Partnerships to Develop COVID-19 Vaccines in Record Time
  |   | 
Date and Time: |   | Tuesday, June 9, 11:30 a.m. PDT
  |   | 
Moderator: |   | Mark McClellan, M.D., Director, Duke Margolis Center for Health Policy
  |   | 
Panelists: |   | Dr. Glenn
Margaret Hamburg, M.D., Foreign Secretary, National Academy of Medicine
Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research, United States Food and Drug Administration
Paul Stoffels, M.D., Vice Chairman of the Executive Committee, Chief Scientific Officer, Johnson & Johnson

https://flashalert.me/?symbol=NVAX&source=PR&referer=https://stocktwits.com/&url=http://www.globenewswire.com/news-release/2020/06/08/2045200/0/en/Novavax-President-of-R-D-Dr-Gregory-Glenn-to-Discuss-the-Development-of-COVID-19-Vaccines-on-Panel-at-2020-BIO-Digital.html&s3=NVAX/2020-06-08/16-06-59_000000/glob/8e61e7769db297526a6002be565545c1/Novavax-President-of-R-D-Dr-Gregory-Glenn-to-Discuss-the-Development-of-COVID-19-Vaccines-on-Panel-at-2020-BIO-Digital.html