Post by marriott on Sept 4, 2022 23:04:11 GMT
Let's review some developments concerning Novavax over the past three weeks :
Aug. 17, 2022 - New Zealand's Medsafe granted expanded provisional approval for Nuvaxovid™ (NVXCoV2373) COVID-19 vaccine for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as a heterologous and homologous booster dose in adults aged 18 and older.
Aug. 18, 2022 - New Zealand's Medsafe granted expanded provisional approval for Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adolesce
Aug. 19, 2022 - Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) received expanded emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) to provide a two-dose primary series for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adolescents aged 12 through 17.
Aug 22, 2022 - U.S. Centers for Disease Control and Prevention (CDC) recommended expanding the use of Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) as a two-dose primary series for active immunization to prevent coronavirus disease 2019 caused by the severe acute respiratory syndrome coronavirus 2 to adolescents aged 12 through 17. The Interim Clinical Considerations on its website have been updated accordingly.
Aug. 26, 2022 - Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) granted expanded conditional marketing authorization (CMA) for Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adolescents aged 12 through 17.
Sept. 1, 2022 - Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine was recommended for expanded conditional marketing authorization (CMA) in the European Union (EU) as a homologous and heterologous booster for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) for adults aged 18 and older.
Sept. 2, 2022 - the World Health Organization (WHO) has approved a variation to allow SK bioscience to manufacture and supply the active substance in the Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine. This variation approval enables Novavax to manufacture product for countries who recognize WHO exceptional use license from two major vaccine suppliers – SK bioscience and the Serum Institute of India. This approval is the first Coalition for Epidemic Preparedness Innovations (CEPI)-funded network production for Novavax. SK bioscience currently manufactures drug substance and drug product of Nuvaxovid for the South Korean market, drug substance for the European Union, and now, drug substance for the WHO as well.
Sept. 2, 2022 - Swissmedic, the Swiss Agency for Therapeutic Products, expanded its temporary authorization of Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine in Switzerland for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adolescents aged 12 through 17 and as a heterologous and homologous booster dose for adults aged 18 and older.
Now let's review the share price moves over the exactly the same time period:
Novavax share price closed on the following dates at :
August 16 , 2022 closed 42.88
September 02, 2022 closed 30.39
DOWN 29.1 per cent notwithstanding the very positive news emanating from various global health sources .
WHY !
Dear Novavax leadership , the market is saying very clearly and simply :
Tell us HOW Novavax plans to produce and ship the doses to the various approved markets .
Tell us about the current status of Praha Vaccines . Tell us specifically what markets and in what quantities doses will be delivered .
Just a reminder that on a conference call held in August 2020 , Filip Dubovsky said that Novavax expects to be able to make "well over a couple billion units" each year, starting in 2021. And Mr Erck added that Praha will have an annual capacity of 1 billion doses .
With the number of employees rising , please tell the market how cash burn will reconciled . Just a word of caution , the market is already hearing echoes of secondary .
Tell us specifically what markets and in what quantities SII will deliver doses .
Will Takeda step up and supply markets other than Japan ? If so , declare the markets and projected quantities.
TO NOVAVAX LEADERSHIP :
I could go on but I think you get the point that Novavax must clearly communicate HOW , WHEN and WHERE future doses will be DELIVERED .
Aug. 17, 2022 - New Zealand's Medsafe granted expanded provisional approval for Nuvaxovid™ (NVXCoV2373) COVID-19 vaccine for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as a heterologous and homologous booster dose in adults aged 18 and older.
Aug. 18, 2022 - New Zealand's Medsafe granted expanded provisional approval for Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adolesce
Aug. 19, 2022 - Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) received expanded emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) to provide a two-dose primary series for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adolescents aged 12 through 17.
Aug 22, 2022 - U.S. Centers for Disease Control and Prevention (CDC) recommended expanding the use of Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) as a two-dose primary series for active immunization to prevent coronavirus disease 2019 caused by the severe acute respiratory syndrome coronavirus 2 to adolescents aged 12 through 17. The Interim Clinical Considerations on its website have been updated accordingly.
Aug. 26, 2022 - Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) granted expanded conditional marketing authorization (CMA) for Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adolescents aged 12 through 17.
Sept. 1, 2022 - Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine was recommended for expanded conditional marketing authorization (CMA) in the European Union (EU) as a homologous and heterologous booster for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) for adults aged 18 and older.
Sept. 2, 2022 - the World Health Organization (WHO) has approved a variation to allow SK bioscience to manufacture and supply the active substance in the Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine. This variation approval enables Novavax to manufacture product for countries who recognize WHO exceptional use license from two major vaccine suppliers – SK bioscience and the Serum Institute of India. This approval is the first Coalition for Epidemic Preparedness Innovations (CEPI)-funded network production for Novavax. SK bioscience currently manufactures drug substance and drug product of Nuvaxovid for the South Korean market, drug substance for the European Union, and now, drug substance for the WHO as well.
Sept. 2, 2022 - Swissmedic, the Swiss Agency for Therapeutic Products, expanded its temporary authorization of Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine in Switzerland for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adolescents aged 12 through 17 and as a heterologous and homologous booster dose for adults aged 18 and older.
Now let's review the share price moves over the exactly the same time period:
Novavax share price closed on the following dates at :
August 16 , 2022 closed 42.88
September 02, 2022 closed 30.39
DOWN 29.1 per cent notwithstanding the very positive news emanating from various global health sources .
WHY !
Dear Novavax leadership , the market is saying very clearly and simply :
Tell us HOW Novavax plans to produce and ship the doses to the various approved markets .
Tell us about the current status of Praha Vaccines . Tell us specifically what markets and in what quantities doses will be delivered .
Just a reminder that on a conference call held in August 2020 , Filip Dubovsky said that Novavax expects to be able to make "well over a couple billion units" each year, starting in 2021. And Mr Erck added that Praha will have an annual capacity of 1 billion doses .
With the number of employees rising , please tell the market how cash burn will reconciled . Just a word of caution , the market is already hearing echoes of secondary .
Tell us specifically what markets and in what quantities SII will deliver doses .
Will Takeda step up and supply markets other than Japan ? If so , declare the markets and projected quantities.
TO NOVAVAX LEADERSHIP :
I could go on but I think you get the point that Novavax must clearly communicate HOW , WHEN and WHERE future doses will be DELIVERED .