#131049
Re: Farmas USA
NVAX vaya tuit de biotech2k contra NVAX
Se está hablando de:
#131050
Re: Farmas USA
NVAX
Sí, cuando pasan cosas de estas aparece a hacer un yoyalodije. Como dijo que ya no habría pandemia este verano y otras muchas que estaba bastante equivocado. Se asomó por el foro de Novavax en IV hace unos meses y Red lo dejó en evidencia y no volvió (le dijo que no tenía ni puta idea vaya 😅).
Sí, cuando pasan cosas de estas aparece a hacer un yoyalodije. Como dijo que ya no habría pandemia este verano y otras muchas que estaba bastante equivocado. Se asomó por el foro de Novavax en IV hace unos meses y Red lo dejó en evidencia y no volvió (le dijo que no tenía ni puta idea vaya 😅).
#131051
Re: Farmas USA
NVAX diario por ahora
en zona de fibo 38.20 ... deberia verse el 50% pronto
no me acordaba del dia que era, me toca gestionar extraescolares ... dejo el dia como esta y a ver que me encuentro en la power hour
#131052
Re: Farmas USA
Yo he entrado en apertura a 131..y he visto los 147 y he estado tentado...a ver si no me arrepiento.
NVAX
NVAX
#131053
Re: Farmas USA
DNA vendidas las de 11,4 a 13,70
saludos!
saludos!
#131054
Re: Farmas USA
NVAX
Si no fuera tan conservador (acojonado), le tenía que haber metido más y haber aguantado la segunda remesa que he comprado. Pero bueno, también evito pérdidas cuando vienen mal dadas...
De IV:
Destaco esto:
In our discussion w/ mgmt, they note exUS standards are not lower per se, but it is more just a matter of coming to agreement on what needs to be demonstrated in order to support submission w/ FDA. Moreover, mgmt imptly highlighted each EUA application is tied to a specific supply chain (i.e. FDA is only reviewing US supply chain).
Traducción: sí, tenemos problemas en usa pero solo en usa.
--
Jefferies - (1) it is making high-quality and safe vaccine at all its sites, (2) plans to file to the UK, EU and others within the next two wks
Caught up w/ Mgmt Following the Recent News Report on FDA CMC Req and Filing…
Date October 20, 2021
Key Takeaway
A Politico report suggests NVAX is having issues meeting FDA CMC manufacturing requirements for submission of its CV-19 vaccine in the US. We had a chance to catch up w/ mgmt to discuss the report and progress. The co reiterated (1) it is making high-quality and safe vaccine at all its sites, (2) plans to file to the UK, EU and others within the next two wks and (3) it is actively working on completing the CMC requirements to support US EUA filing before YE.
RATING
BUY
TICKER
NVAX
PRICE
$160.55^
MARKET CAP
$11.9B
PRICE TARGET (PT)
$250.00
^Prior trading day's closing price unless otherwise noted.
Price: Pre-Market price
Insights
What happened? Yesterday evening, Politico published a report suggesting NVAX is struggling to produce vaccine at a purity level that consistently meets FDA standards for regulatory approval, citing unnamed sources familiar with discussions between NVAX and the Biden Administration. The report says FDA works out vaccine purity requirements with each vaccine manufacturer, but generally purity should be at least 90% and NVAX has only produced vaccine at 70% purity levels. The piece goes on to say the unnamed individuals are unsure NVAX has the expertise to address the CMC manufacturing requirements and approval of its vaccine could be delayed to late 2022.
Mgmt expects to file to UK, EU and other countries within the next couple of weeks....With regard to EU, UK and other exUS submissions, NVAX reiterated it has validated the CMC assays, and notably the parameters for the assays, with regulators. While not providing exact numbers on purity levels, they remain confident in the comparability of the vaccine they are producing at commercial scale with the Phase II/III product, and plan on filing "within the next couple of weeks," which is in line w/ mgmt updated September guidance. We note NVAX and its partner Serum Institute of India (SII) have already filed EUA/EUL packages to WHO, India and the other countries suggesting they can make the vaccine consistently. Other exUS partners, Takeda and SK Bioscience, remain bullish on the vaccine based on public comments.
Mgmt remains confident in their ability to produce high quality vaccine and submit an EUA to the FDA before YE... On the Q2 call and subsequent public presentations, mgmt. has generally positioned the US filing requirements as different from what other regulatory agencies, including the UK/EU, have wanted to support regulatory submissions. In our discussion w/ mgmt, they note exUS standards are not lower per se, but it is more just a matter of coming to agreement on what needs to be demonstrated in order to support submission w/ FDA. Moreover, mgmt imptly highlighted each EUA application is tied to a specific supply chain (i.e. FDA is only reviewing US supply chain). Thus, in our view, if there were issues with vaccine production in the US, it would be exclusive to that application. NVAX remains in discussion with the FDA on the CMC package and continues to plan to file in the US before YE, although we think there could be some risk to achieving that timeline. However, considering the oppty for NVAX is mostly exUS over the near-term, a delay in the US filing should not be material.
Si no fuera tan conservador (acojonado), le tenía que haber metido más y haber aguantado la segunda remesa que he comprado. Pero bueno, también evito pérdidas cuando vienen mal dadas...
De IV:
Destaco esto:
In our discussion w/ mgmt, they note exUS standards are not lower per se, but it is more just a matter of coming to agreement on what needs to be demonstrated in order to support submission w/ FDA. Moreover, mgmt imptly highlighted each EUA application is tied to a specific supply chain (i.e. FDA is only reviewing US supply chain).
Traducción: sí, tenemos problemas en usa pero solo en usa.
--
Jefferies - (1) it is making high-quality and safe vaccine at all its sites, (2) plans to file to the UK, EU and others within the next two wks
Caught up w/ Mgmt Following the Recent News Report on FDA CMC Req and Filing…
Date October 20, 2021
Key Takeaway
A Politico report suggests NVAX is having issues meeting FDA CMC manufacturing requirements for submission of its CV-19 vaccine in the US. We had a chance to catch up w/ mgmt to discuss the report and progress. The co reiterated (1) it is making high-quality and safe vaccine at all its sites, (2) plans to file to the UK, EU and others within the next two wks and (3) it is actively working on completing the CMC requirements to support US EUA filing before YE.
RATING
BUY
TICKER
NVAX
PRICE
$160.55^
MARKET CAP
$11.9B
PRICE TARGET (PT)
$250.00
^Prior trading day's closing price unless otherwise noted.
Price: Pre-Market price
Insights
What happened? Yesterday evening, Politico published a report suggesting NVAX is struggling to produce vaccine at a purity level that consistently meets FDA standards for regulatory approval, citing unnamed sources familiar with discussions between NVAX and the Biden Administration. The report says FDA works out vaccine purity requirements with each vaccine manufacturer, but generally purity should be at least 90% and NVAX has only produced vaccine at 70% purity levels. The piece goes on to say the unnamed individuals are unsure NVAX has the expertise to address the CMC manufacturing requirements and approval of its vaccine could be delayed to late 2022.
Mgmt expects to file to UK, EU and other countries within the next couple of weeks....With regard to EU, UK and other exUS submissions, NVAX reiterated it has validated the CMC assays, and notably the parameters for the assays, with regulators. While not providing exact numbers on purity levels, they remain confident in the comparability of the vaccine they are producing at commercial scale with the Phase II/III product, and plan on filing "within the next couple of weeks," which is in line w/ mgmt updated September guidance. We note NVAX and its partner Serum Institute of India (SII) have already filed EUA/EUL packages to WHO, India and the other countries suggesting they can make the vaccine consistently. Other exUS partners, Takeda and SK Bioscience, remain bullish on the vaccine based on public comments.
Mgmt remains confident in their ability to produce high quality vaccine and submit an EUA to the FDA before YE... On the Q2 call and subsequent public presentations, mgmt. has generally positioned the US filing requirements as different from what other regulatory agencies, including the UK/EU, have wanted to support regulatory submissions. In our discussion w/ mgmt, they note exUS standards are not lower per se, but it is more just a matter of coming to agreement on what needs to be demonstrated in order to support submission w/ FDA. Moreover, mgmt imptly highlighted each EUA application is tied to a specific supply chain (i.e. FDA is only reviewing US supply chain). Thus, in our view, if there were issues with vaccine production in the US, it would be exclusive to that application. NVAX remains in discussion with the FDA on the CMC package and continues to plan to file in the US before YE, although we think there could be some risk to achieving that timeline. However, considering the oppty for NVAX is mostly exUS over the near-term, a delay in the US filing should not be material.
#131055
Re: Farmas USA
No se puede tener todo.
No quedarse pillado por haber operado a tiempo y acertadamente antes de un mamporro como el de hoy ... Vaso medio lleno o lleno del todo 🤟
Si cierra el gap esta semana la vela semanal sería tremenda. Aunque si no supera los fibos es mas que probable que haga un retest y doble botóm de algún tipo.
En cualquier caso esto es una maratón de metesacas, si haces las cosas bien y te libras de los malos ratos como este se acaba sacando partido al cabo del año aunque es imposible exprimir el asunto siempre al maximo. Eso sí no tengo ya claro si todo lo que le exprimimos a esta bicha es suficiente para compensar las canas que genera .. esto tiene que quitar años de vida 🙈 sobre todo para el que no opera y solo espera.
#131056
Re: Farmas USA
En zona de 117-120?
Jeje que me habia colau con el 2
Jeje que me habia colau con el 2