Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
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Looks like the only ones buying this stock are Biontech themselves...
NEW YORK & MAINZ, Germany -- (Business Wire)
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced a new vaccine supply agreement with the U.S. government to support the continued fight against COVID-19. Under the agreement, the U.S. government will receive 105 million doses (30 microg, 10 microg and 3 microg). This may include adult Omicron-adapted COVID-19 vaccines, subject to authorization from the U.S. Food and Drug Administration (FDA). The doses are planned to be delivered as soon as late summer 2022 and continue into the fourth quarter of this year.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220629005833/en/
The U.S. government will pay the companies $3.2 billion upon receipt of the first 105 million doses. Under this agreement, the U.S. government also has the option to purchase up to 195 million additional doses, bringing the total number of potential doses to 300 million.
"As the virus evolves, this new agreement will help ensure people across the country have access to vaccines that may provide protection against current and future variants," said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. "Vaccines have been and will remain critical to protecting people of all ages against COVID-19. We remain proud of our long-term partnership with the U.S. government in helping to address this pandemic, and of the ongoing impact of vaccination efforts in the U.S. and around the world."
"This agreement will provide additional doses for U.S. residents and help cope with the next COVID-19 wave. Pending regulatory authorization, it will also include an Omicron-adapted vaccine, which we believe is important to address the rapidly spreading Omicron variant," said Sean Marett, Chief Business and Chief Commercial Officer of BioNTech. "We appreciate the continued partnership of the U.S. government in our shared goal to help end this pandemic."
Not much shareholder value here, they will buy the shares back after a 20 % down kicking and present that as returning shareholder value ! If they have any dignity they should buy the shares back at the price before the fall, now that would be returning shareholder value !
Just need some support from our management that have vanished.
BioNTech Announces ADS Repurchase Program
2022-03-31 07:00 ET - News Release
MAINZ, Germany, March 31, 2022 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, "BioNTech" or the "Company") today announced that it has entered into a share repurchase program (the "Program"), pursuant to which the Company may purchase American depositary shares (ADSs) in the amount of up to $1.5 billion over the next two years. BioNTech expects to use all or a portion of the ADSs to satisfy upcoming settlement obligations under the Company's share-based payment arrangements.
"We would like our shareholders to participate in our strong 2021 performance through a repurchase program of BioNTech shares. This is in line with our capital allocation strategy and our aim to continue to drive shareholder value," said Jens Holstein, CFO of BioNTech.
The timing and total amount of ADS repurchases will depend upon market conditions and may be made in open market purchases from time to time.
The Program has been designed to operate within the safe harbor provided by Rule 10b-18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), and the affirmative defense provided by Rule 10b5-1 of the Exchange Act.
Pfizer and BioNTech Announce Data Demonstrating High Immune Response Following a Booster Dose of Their COVID-19 Vaccine in Children 5 Through 11 Years of Age
2022-04-14 06:46 ET - News Release
Data from a subanalysis of 30 sera from a Phase 2/3 clinical trial of children 5 through 11 years of age show a 36-fold increase in SARS-CoV-2 Omicron neutralizing titers following a booster (third) dose of the Pfizer-BioNTech COVID-19 Vaccine
In the Phase 2/3 clincal trial with 140 children a booster (third) dose of the Pfizer-BioNTech COVID-19 Vaccine increased neutralizing antibodies by 6-fold against the SARS-CoV-2 wild-type strain in this age group
Companies plan to submit these data to U.S. Food and Drug Administration in the coming days with additional submissions to other regulatory agencies worldwide to follow
NEW YORK and MAINZ, Germany, April 14, 2022 - Pfizer Inc. (NYSE: PFE, "Pfizer") and BioNTech SE (Nasdaq: BNTX, "BioNTech") today announced positive results from a Phase 2/3 clinical trial evaluating the safety, tolerability and immunogenicity of a 10-microg booster (third) dose of the Pfizer-BioNTech COVID-19 vaccine in healthy children 5 through 11 years of age. These data demonstrate an increase in SARS-CoV-2 Omicron variant and wild-type strain neutralizing titers following a booster dose of the Pfizer-BioNTech COVID-19 vaccine compared to two doses. These data reinforce the potential function of a third dose of the vaccine in maintaining high levels of protection against the virus in this age group.
In the Phase 2/3 clinical trial, data were analyzed from 140 children 5 through 11 years of age who received a booster dose approximately 6 months after the second dose of the Pfizer-BioNTech COVID-19 vaccine 10-microg primary series . Data from a subanalysis of 30 sera from this study indicate that serum antibodies induced by a third dose neutralize the SARS-CoV-2 Omicron variant in this age group, as demonstrated by a 36-fold increase in neutralizing antibody titers compared to levels seen after two doses of the Pfizer-BioNTech COVID-19 Vaccine. A robust response was observed regardless of prior SARS-CoV-2 infection.
Further, immunogencity data from the 140 participants of the Phase 2/3 clincal trial who had no evidence of prior SARS-CoV-2 infection showed a 6-fold increase (95% CI: 5.0, 7.6) in SARS-CoV-2 wild-type strain-neutralizing geometric mean titers (GMTs) one month after the booster compared to the SARS-CoV-2-neutralizing GMTs one month after the second dose of the primary series of the Pfizer-BioNTech COVID-19 vaccine, demonstrating a strong immune response in this age group. To date, more than 10,000 children under the age of 12 have participated in clinical trials investigating the Pfizer-BioNTech COVID-19 vaccine, and in this most recent booster data readout (n=401), the vaccine was well tolerated with no new safety signals observed.
Pfizer and BioNTech plan to submit a request for Emergency Use Authorization
BioNTech Presents Positive Preliminary Phase 1/2 Data for First-in-Class CAR-T Program BNT211 at AACR
2022-04-11 03:55 ET - News Release
BNT211 combines two innovative approaches in one regimen, an autologous CAR-T cell therapy targeting the oncofetal antigen Claudin-6 (CLDN6) and a CLDN6-encoding CAR-T cell amplifying RNA vaccine (CARVac) to improve persistence and functionality of the adoptively transferred cells
Treatment with BNT211 alone or in combination with CARVac, currently being tested in a Phase 1/2 Trial in patients with advanced solid tumors, was well tolerated across multiple tumor indications in preliminary data from 16 patients
Preliminary efficacy data showed encouraging signs of clinical activity with a disease control rate of 86% and an overall response rate of 43%
MAINZ, Germany, April 11, 2022 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") presented data from its ongoing first-in-human Phase 1/2 trial evaluating the safety and preliminary efficacy of the Company's novel CAR-T cell therapy candidate, BNT211, in patients with advanced solid tumors. The preliminary results demonstrated an encouraging safety profile and anti-tumor activity in testicular cancer patients at the first evaluated dose levels of BNT211. The data were presented in the Clinical Trials Plenary Session at the AACR Annual Meeting 2022 by Prof. John Haanen, M.D., Ph.D., Netherlands Cancer Institute (NKI), Amsterdam, Netherlands.
BNT211 is a potential first-in-class therapeutic approach which comprises two drug products, an autologous CAR-T cell therapy targeting the oncofetal antigen Claudin-6 (CLDN6) and a CLDN6-encoding CAR-T cell amplifying RNA vaccine (CARVac), which is based on BioNTech's mRNA-lipoplex technology to improve persistence and functionality of the adoptively transferred cells.
The presentation included data from 16 patients who received CLDN6 CAR-T cells at dose levels 1 (1x107 CAR-T cells) and 2 (1x108 CAR-T cells) alone or combined with CARVac. Tumor indications included testicular cancer (n=8) ovarian cancer (n=4), endometrial cancer, fallopian tube cancer, sarcoma, and gastric cancer (1 patient each). Treatment with CLDN6 CAR-T alone or in combination with CARVac up to dose level 2 was well tolerated and showed encouraging signs of clinical activity. All 16 patients showed robust CAR-T cell expansion 10-17 days after infusion with cell frequencies close to 109 total counts in dose level 2. Adverse events and dose limiting toxicities were manageable; cytokine release syndromes of grade 1 and 2 and one transient occurrence of neurotoxicity grade 1 were observed.
At the first efficacy assessment 6 weeks post infusion, 6 of 14 evaluable patients showed a partial response, and 5 patients had stable disease with shrinkage of target lesions. One patient showed no change from baseline and two patients were progressing. Responses were seen in testicular (n=4) and ovarian cancer (n=2) patients. At
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