"Chyba trzeba pozbawić się złudzeń że cd20 takie procedowanie przejdzie"
o tym samym wczoraj pomyślałem, a oglądałem tylko część.
Ale dodać należy, że "obrotowy" ten, który odpowiadał z NVAX, któy odpowiadał na pytania tłumaczył itd, odwalił kawał dobrej roboty. Może w przyszłości będzie supportował MAB
MABION [MAB] księga XIV w trakcie rejestracji CD20
REKLAMA
Re: MABION [MAB] księga XIV w trakcie rejestracji CD20
Na bankierze niezłą z ciebie mają bekę kolego "all"Ciekawe jest to, ze jak ktos sluchal dzisiaj tej calej szopki FDA to jest z pewnoscia przekonany, ze partycypanci zarowno ze strony spolki jak i FDA przed przystapieniem do posiedzenia wiedzieli jaki bedzie jego wynik. Dlatego NVX wnioskowal o zawieszenie handlu i usmazyl szorciarzy w USA. Do tego wyniki w zakresie zapaleni miesnia sercowego po szczegolowej analizie nie odbiegaja od szczepionek mRNA. Co ciekawe przy rejestracji szczepionek Pfizera czy Moderny nie mowiloCiekawe, ze zatwierdzili.
Zwłaszcza w kontekście najnowszych doniesień:
https://www.dw.com/pl/skutki-uboczne-sz ... a-62033142
Amerykańska Agencja ds. Żywności i Leków (FDA) jest zaniepokojona możliwym ryzykiem wystąpienia zapalenia mięśnia sercowego w przypadku szczepionki przeciwko SARS-CoV-2 firmy Novavax.
sie tak glosno i nie zwracalo uwagi na te powiklania a chyba, jesli dobrze widzialem, byly one czestsze. Wiec ta cala big farma wraz z FDA lekko zalatuje zgnila ryba. Szczegolnie, ze w tym FDA to malo kto mowil czysta angielszczyzna.
Wiesz jaką dają ci ksywę:
CHORĄGIEWKA.
P.S .
Czy oddałeś już kasę rodzinie za wikt, opierunek i naukę.
08.01.21 napisałem, że Mabion podpiszę umowę Novavaxem - kurs 22 zł
NIKT NA FORUM MI NIE UWIERZYŁ
03.03.21 Mabion ogłosił umowę Novavaxem
NIKT NA FORUM MI NIE UWIERZYŁ
03.03.21 Mabion ogłosił umowę Novavaxem
Re: MABION [MAB] księga XIV w trakcie rejestracji CD20
Po pierwsze juz ci pisalem - zwieksz dawke lekow lub zmien lekarza, bo na dzisiaj osoby z wiekszymi zaburzeniami psychicznymi na forum nie ma.
Po drugie - nigdy nie pisalem na bankierze na watku mabionu, wiec patrz punkt pierwszy.
Po drugie - nigdy nie pisalem na bankierze na watku mabionu, wiec patrz punkt pierwszy.
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Re: MABION [MAB] księga XIV w trakcie rejestracji CD20
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Coś zaczynają się spieszyć z dystrybucją kwi†ów przed otwarciem w USA
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*** kosmos
At close: June 6 04:00PM EDT
51.25 +3.71 (+7.80%)
Pre-Market: 8:21AM EDT
Coś zaczynają się spieszyć z dystrybucją kwi†ów przed otwarciem w USA
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As of 10:27AM EDT. Market open.
*** kosmos
Ostatnio zmieniony 08 cze 2022 16:27 przez palacz2009, łącznie zmieniany 1 raz.
Re: MABION [MAB] księga XIV w trakcie rejestracji CD20
NVX to zaraz bedzie na minusie
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Re: MABION [MAB] księga XIV w trakcie rejestracji CD20
ostatnie palta na lata rozdaneNVX to zaraz bedzie na minusie
Novavax, Inc. (NVAX)
46.82-0.72 (-1.51%)
As of 11:00AM EDT. Market open.
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Re: MABION [MAB] księga XIV w trakcie rejestracji CD20
50.11+2.57 (+5.41%)
At close: June 8 04:00PM EDT
46.76 -3.35 (-6.69%)
Pre-Market: 07:45AM EDT
Dzisiaj dożynki się szykują
At close: June 8 04:00PM EDT
46.76 -3.35 (-6.69%)
Pre-Market: 07:45AM EDT
Dzisiaj dożynki się szykują
Re: MABION [MAB] księga XIV w trakcie rejestracji CD20
Niezłe gnioty
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- Rejestracja: 18 kwie 2009 10:43
Re: MABION [MAB] księga XIV w trakcie rejestracji CD20
41.55-8.56 (-17.09%)
As of 01:31PM EDT. Market open.
Kurs tak zapier la jak inflacja w Polsce
As of 01:31PM EDT. Market open.
Kurs tak zapier la jak inflacja w Polsce
Re: MABION [MAB] księga XIV w trakcie rejestracji CD20
Niezły roller coaster, insajderzy z FDA zarabiają miliony usd na Novavax:
https://www.cnbc.com/2022/06/09/fda-dec ... ayed-.html
https://www.cnbc.com/2022/06/09/fda-dec ... ayed-.html
Re: MABION [MAB] księga XIV w trakcie rejestracji CD20
Tutaj macie misie opisana historię aplikacji Novavax do FDA z ostatnich miesięcy.
Novavax CEO Stanley Erck looked at the clock, in a conference room surrounded by about 30 colleagues, as the Food and Drug Administration advisory committee chairman called for a vote Tuesday afternoon. It was just before 3:30 p.m. — an hour and a half earlier than expected.
Members of the Vaccines and Related Biological Products Advisory Committee started entering their votes into the electronic system. A recommendation for emergency use authorization for Novavax’s experimental Covid-19 vaccine would be critical to an ultimate green light.
“What surprised me was that the meeting actually ended early, which almost never happens with the VRBPAC meetings. There are always questions,” Erck said in an interview. “Everybody, of course, was on pins and needles.”
The vote tally appeared on the screen after about two minutes as 21-0 with one abstention, all in support that the benefits of the vaccine outweigh the risks.
“Everybody just stood up in applause,” Erck said. “It’s such tension and then there’s this relief that they all saw what we did. It was a happy moment.”
Before the meeting
The Gaithersburg biotech, with no product to market in its 35-year history, now awaits the FDA’s decision about whether to greenlight its shot as the fourth available in the U.S.
The date for Tuesday’s meeting was set at the end of April, a day after the FDA finished its inspection Serum Institute of India’s manufacturing site in Pune, India, which is making the product for U.S. distribution.
“They thought about inspecting it with a fairly low-level, quick EUA-type inspection, but then changed their mind and sent a whole group of people for a week and a half to inspect, and we came out really clean on the inspection,” Erck said. “That was really important.”
Over the next several weeks, Novavax’s team “spent a great deal of time practicing and thinking about all of the questions that any VRBPAC member would have,” Erck said, adding that “there were no surprises” at the meeting.
That included whether there’s enough demand for another vaccine, in a landscape with three others already available. And “there’s not a need for more vaccines quantity-wise in the U.S. — there’s plenty of supply,” Erck said, “but what there’s a need for is an alternative vaccine.”
It also included the discussion about whether the vaccine would need a warning statement about a potential link to myocarditis and pericarditis, types of heart inflammation, after four cases in young men occurred in clinical trials. The risk is also associated with mRNA vaccines, but Novavax argues the data for its vaccine don’t support that connection.
Novavax is now waiting to see what the FDA will decide, Erck said. “It’s an important safety issue that we’ll watch, like everything else, as we roll out the vaccine in the United States.”
After the meeting
About 100 employees gathered in the cafeteria of the company’s new building for champagne and a catered lunch after the meeting, “congratulating each other and celebrating,” Erck said.
Employees had gradually started moving into that new headquarters building on Quince Orchard Road in Gaithersburg earlier this year. The space represents a transformation for the biotech, which was a small and struggling company with 150 people and a six-month cash runway at the start of the pandemic — and now, counts 2,000 employees with billions projected in 2022.
“Every one of those 2,000 people, once we got to 4 o’clock on Tuesday, they just had this huge emotional release,” Erck said. “Everybody felt really proud, as did I.”
That night, Erck said, he and his wife went to dinner “and we just thought about what has been accomplished over the last few years.”
What happens next
Novavax’s (NASDAQ: NVAX) stock fell more than 15% to a low of $42.46 Thursday, still with no FDA announcement two days after the advisory committee’s meeting.
The agency said it’s considering the recommendation, as well as updated manufacturing process information the company submitted June 3. “FDA will carefully review this and any additional information submitted by the firm as part of its ongoing assessment and prior to authorizing the vaccine for emergency use,” a spokesperson said in a statement Wednesday to the Washington Business Journal.
Novavax submitted those materials when it did, Erck said, so there would be “nothing outstanding from the company’s point of view” at the time of the meeting. The company had first submitted its EUA application earlier this year and is “always making improvements” to its manufacturing process, he added. “The FDA should, and gets to, review all of the submissions that we make, and they’re doing that right now.”
Novavax is making product for U.S. distribution as the FDA considers the vaccine for EUA. The company expects to be shipping “a few million doses” later this month, but the exact amount of vaccine for U.S. delivery would be finalized following an authorization, Erck said. “Everything is on track.”
link płatny
https://www.bizjournals.com/washington/ ... k-fda.html
Novavax CEO Stanley Erck looked at the clock, in a conference room surrounded by about 30 colleagues, as the Food and Drug Administration advisory committee chairman called for a vote Tuesday afternoon. It was just before 3:30 p.m. — an hour and a half earlier than expected.
Members of the Vaccines and Related Biological Products Advisory Committee started entering their votes into the electronic system. A recommendation for emergency use authorization for Novavax’s experimental Covid-19 vaccine would be critical to an ultimate green light.
“What surprised me was that the meeting actually ended early, which almost never happens with the VRBPAC meetings. There are always questions,” Erck said in an interview. “Everybody, of course, was on pins and needles.”
The vote tally appeared on the screen after about two minutes as 21-0 with one abstention, all in support that the benefits of the vaccine outweigh the risks.
“Everybody just stood up in applause,” Erck said. “It’s such tension and then there’s this relief that they all saw what we did. It was a happy moment.”
Before the meeting
The Gaithersburg biotech, with no product to market in its 35-year history, now awaits the FDA’s decision about whether to greenlight its shot as the fourth available in the U.S.
The date for Tuesday’s meeting was set at the end of April, a day after the FDA finished its inspection Serum Institute of India’s manufacturing site in Pune, India, which is making the product for U.S. distribution.
“They thought about inspecting it with a fairly low-level, quick EUA-type inspection, but then changed their mind and sent a whole group of people for a week and a half to inspect, and we came out really clean on the inspection,” Erck said. “That was really important.”
Over the next several weeks, Novavax’s team “spent a great deal of time practicing and thinking about all of the questions that any VRBPAC member would have,” Erck said, adding that “there were no surprises” at the meeting.
That included whether there’s enough demand for another vaccine, in a landscape with three others already available. And “there’s not a need for more vaccines quantity-wise in the U.S. — there’s plenty of supply,” Erck said, “but what there’s a need for is an alternative vaccine.”
It also included the discussion about whether the vaccine would need a warning statement about a potential link to myocarditis and pericarditis, types of heart inflammation, after four cases in young men occurred in clinical trials. The risk is also associated with mRNA vaccines, but Novavax argues the data for its vaccine don’t support that connection.
Novavax is now waiting to see what the FDA will decide, Erck said. “It’s an important safety issue that we’ll watch, like everything else, as we roll out the vaccine in the United States.”
After the meeting
About 100 employees gathered in the cafeteria of the company’s new building for champagne and a catered lunch after the meeting, “congratulating each other and celebrating,” Erck said.
Employees had gradually started moving into that new headquarters building on Quince Orchard Road in Gaithersburg earlier this year. The space represents a transformation for the biotech, which was a small and struggling company with 150 people and a six-month cash runway at the start of the pandemic — and now, counts 2,000 employees with billions projected in 2022.
“Every one of those 2,000 people, once we got to 4 o’clock on Tuesday, they just had this huge emotional release,” Erck said. “Everybody felt really proud, as did I.”
That night, Erck said, he and his wife went to dinner “and we just thought about what has been accomplished over the last few years.”
What happens next
Novavax’s (NASDAQ: NVAX) stock fell more than 15% to a low of $42.46 Thursday, still with no FDA announcement two days after the advisory committee’s meeting.
The agency said it’s considering the recommendation, as well as updated manufacturing process information the company submitted June 3. “FDA will carefully review this and any additional information submitted by the firm as part of its ongoing assessment and prior to authorizing the vaccine for emergency use,” a spokesperson said in a statement Wednesday to the Washington Business Journal.
Novavax submitted those materials when it did, Erck said, so there would be “nothing outstanding from the company’s point of view” at the time of the meeting. The company had first submitted its EUA application earlier this year and is “always making improvements” to its manufacturing process, he added. “The FDA should, and gets to, review all of the submissions that we make, and they’re doing that right now.”
Novavax is making product for U.S. distribution as the FDA considers the vaccine for EUA. The company expects to be shipping “a few million doses” later this month, but the exact amount of vaccine for U.S. delivery would be finalized following an authorization, Erck said. “Everything is on track.”
link płatny
https://www.bizjournals.com/washington/ ... k-fda.html
08.01.21 napisałem, że Mabion podpiszę umowę Novavaxem - kurs 22 zł
NIKT NA FORUM MI NIE UWIERZYŁ
03.03.21 Mabion ogłosił umowę Novavaxem
NIKT NA FORUM MI NIE UWIERZYŁ
03.03.21 Mabion ogłosił umowę Novavaxem
Re: MABION [MAB] księga XIV w trakcie rejestracji CD20
WHATEVA rynek powiedział sprawdzamTutaj macie misie opisana historię aplikacji Novavax do FDA z ostatnich miesięcy.
Novavax CEO Stanley Erck looked at the clock, in a conference room surrounded by about 30 colleagues, as the Food and Drug Administration advisory committee chairman called for a vote Tuesday afternoon. It was just before 3:30 p.m. — an hour and a half earlier than expected.
Members of the Vaccines and Related Biological Products Advisory Committee started entering their votes into the electronic system. A recommendation for emergency use authorization for Novavax’s experimental Covid-19 vaccine would be critical to an ultimate green light.
“What surprised me was that the meeting actually ended early, which almost never happens with the VRBPAC meetings. There are always questions,” Erck said in an interview. “Everybody, of course, was on pins and needles.”
The vote tally appeared on the screen after about two minutes as 21-0 with one abstention, all in support that the benefits of the vaccine outweigh the risks.
“Everybody just stood up in applause,” Erck said. “It’s such tension and then there’s this relief that they all saw what we did. It was a happy moment.”
Before the meeting
The Gaithersburg biotech, with no product to market in its 35-year history, now awaits the FDA’s decision about whether to greenlight its shot as the fourth available in the U.S.
The date for Tuesday’s meeting was set at the end of April, a day after the FDA finished its inspection Serum Institute of India’s manufacturing site in Pune, India, which is making the product for U.S. distribution.
“They thought about inspecting it with a fairly low-level, quick EUA-type inspection, but then changed their mind and sent a whole group of people for a week and a half to inspect, and we came out really clean on the inspection,” Erck said. “That was really important.”
Over the next several weeks, Novavax’s team “spent a great deal of time practicing and thinking about all of the questions that any VRBPAC member would have,” Erck said, adding that “there were no surprises” at the meeting.
That included whether there’s enough demand for another vaccine, in a landscape with three others already available. And “there’s not a need for more vaccines quantity-wise in the U.S. — there’s plenty of supply,” Erck said, “but what there’s a need for is an alternative vaccine.”
It also included the discussion about whether the vaccine would need a warning statement about a potential link to myocarditis and pericarditis, types of heart inflammation, after four cases in young men occurred in clinical trials. The risk is also associated with mRNA vaccines, but Novavax argues the data for its vaccine don’t support that connection.
Novavax is now waiting to see what the FDA will decide, Erck said. “It’s an important safety issue that we’ll watch, like everything else, as we roll out the vaccine in the United States.”
After the meeting
About 100 employees gathered in the cafeteria of the company’s new building for champagne and a catered lunch after the meeting, “congratulating each other and celebrating,” Erck said.
Employees had gradually started moving into that new headquarters building on Quince Orchard Road in Gaithersburg earlier this year. The space represents a transformation for the biotech, which was a small and struggling company with 150 people and a six-month cash runway at the start of the pandemic — and now, counts 2,000 employees with billions projected in 2022.
“Every one of those 2,000 people, once we got to 4 o’clock on Tuesday, they just had this huge emotional release,” Erck said. “Everybody felt really proud, as did I.”
That night, Erck said, he and his wife went to dinner “and we just thought about what has been accomplished over the last few years.”
What happens next
Novavax’s (NASDAQ: NVAX) stock fell more than 15% to a low of $42.46 Thursday, still with no FDA announcement two days after the advisory committee’s meeting.
The agency said it’s considering the recommendation, as well as updated manufacturing process information the company submitted June 3. “FDA will carefully review this and any additional information submitted by the firm as part of its ongoing assessment and prior to authorizing the vaccine for emergency use,” a spokesperson said in a statement Wednesday to the Washington Business Journal.
Novavax submitted those materials when it did, Erck said, so there would be “nothing outstanding from the company’s point of view” at the time of the meeting. The company had first submitted its EUA application earlier this year and is “always making improvements” to its manufacturing process, he added. “The FDA should, and gets to, review all of the submissions that we make, and they’re doing that right now.”
Novavax is making product for U.S. distribution as the FDA considers the vaccine for EUA. The company expects to be shipping “a few million doses” later this month, but the exact amount of vaccine for U.S. delivery would be finalized following an authorization, Erck said. “Everything is on track.”
link płatny
https://www.bizjournals.com/washington/ ... k-fda.html
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- Chorąży
- Posty: 938
- Rejestracja: 18 kwie 2009 10:43
Re: MABION [MAB] księga XIV w trakcie rejestracji CD20
40.73-0.75 (-1.81%)
As of 09:34AM EDT. Market open.
na stracie 40 pęknie 18$
As of 09:34AM EDT. Market open.
na stracie 40 pęknie 18$
Re: MABION [MAB] księga XIV w trakcie rejestracji CD20
Wygląda jakby fundamentalnie NVX klepał dno, ale wszystko zależy od sytuacji rynkowej. Bo jak się rynki załamią to może się i przepołowić.
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- Rejestracja: 18 kwie 2009 10:43
Re: MABION [MAB] księga XIV w trakcie rejestracji CD20
Tam są takie fundamenty jak u nas na MabionieWygląda jakby fundamentalnie NVX klepał dno, ale wszystko zależy od sytuacji rynkowej. Bo jak się rynki załamią to może się i przepołowić.
REKLAMA
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