REDHILL B.S.ADR 10/IL-,01 Forum: Community User: MeisterYoda1

hoffentlich: Zulassungsanträge und Gespräche hinsichtlich der Anforderungen an bestätigende Daten und Wege zu einer möglichen Zulassung in den USA, Europa, Großbritannien und weiteren Ländern machen gute Fortschritte

also kann man davon ausgehen, dass wir heute unter 2 kommen ^^ - Ist so ein Gesetz der Serie, gue Nachricht=roter Verlauf.

https://www.dgap.de/dgap/News/corporate/redhill-gibt-effektive-vitrohemmung-der-omikronvariante-durch-seinen-oralen-covidwirkstoffkandidat-opaganib-vivo-bekannt/?newsID=1551301

DGAP-News: RedHill gibt effektive in vitro-Hemmung der Omikron-Variante durch seinen oralen COVID-19-Wirkstoffkandidat Opaganib in vivo bekannt / Quelle: Guidants News https://news.guidants.com

Ist gerade gekommen

RedHill Biopharma (Nasdaq: RDHL) today announced study results in which opaganib (ABC294640), a leading oral drug candidate for hospitalized patients with moderate to severe COVID-19, was observed to have potent in vitro efficacy against the Omicron SARS-CoV-2 variant, while maintaining host cell viability. Based on the new and previously announced data, opaganib’s unique human host-targeted, dual antiviral and anti-inflammatory suggested mechanism is expected to act independently of viral spike protein mutations and remain effective against Omicron sub-variants BA.2, XE and other emerging and future variants. Oral opaganib’s reported potent in vitro activity against Omicron adds to previously observed inhibition of Delta and other SARS-CoV-2 variants of concern that cause COVID-19; Testing conducted by The University of Hong Kong School of Public Health, a world renowned WHO collaborating center Based on the new and previously announced data, opaganib’s unique human host-targeted, dual antiviral and anti-inflammatory suggested mechanism is expected to act independently of viral spike protein mutations and remain effective against Omicron sub-variants BA.2, XE and other emerging and future variants Previously reported phase 2/3 clinical data showed reduced mortality in key subpopulations, improved viral RNA clearance, and faster time to recovery for moderate to severe hospitalized patients treated with opaganib Regulatory submissions and discussions in the U.S., Europe, UK and additional countries are progressing regarding confirmatory data requirements and pathways to potential approval Work on testing opaganib against Omicron was conducted by the Centre for Immunology and Infection (C2i), The University of Hong Kong’s world-renowned infectious diseases research center, School of Public Health, by Dr. Michael Chan, Principal Investigator, of the Centre for Immunology and Infection, who said: “The results of this study showed opaganib exerting potent inhibition of Omicron SARS-CoV-2 variant viral replication in a model that we believe comes as close as currently possible to representing the Omicron clinical pathophysiological pathway. These are highly promising results that lend further weight to opaganib’s hypothesized host-mediated antiviral activity and expected effect irrespective of viral variant.” “Opaganib was tested for inhibition of Omicron SARS-CoV-2 viral replication using an ex vivo human respiratory explant model, a methodology based on the finding that Omicron has a replication advantage in respiratory tract explants culture,” said Reza Fathi, PhD., RedHill’s Senior VP, R&D. “The results of the study, led by Dr. Chan, one of the leading experts in the field who’s extensive COVID-19-related research is widely published in top tier journals such as Nature, are encouraging. The results are also consistent with findings from the Phase 2/3 study in which opaganib was shown, together with reducing mortality in key subpopulations and improving the time to recovery, to accelerate viral RNA clearance by more than 4 days, even in an advanced patient population with a median of 11 days from onset of symptoms – we believe a likely first for a novel oral therapy in this underserved hospitalized moderate to severe COVID-19 patient population

In EU und USA eher nicht meiner Meinung nach. Ich gehe davon aus, dass wir mit Südkorea relativ zeitnah anfangen werden

Ich frage mal naiv: Ist eine schnelle Notfallzulassung denn wirklich realistisch?

Im Grunde genommen steht da nicht viel neues. Die Überschrift ist etwas ketzerich wie ich finde

keine Ahnung

Wie seriös ist diese Quelle?

national treasure investment company rises on news of progress in developing oral corona therapeutics 2022-04-11 14:27, Park Jung-sup Reporter [XML:KR:2 -------- red hill biopharma and opaganib are in the process of being approved for emergency use in the united states and europe. ---------- http://www.nspna.com/news/?mode=view&newsid=564554

Der hat wohl nicht mehr alle Rotzneft-Aktien im Depot, der Kerl.