Laduree

Between EMA opinion and EU approval to market it is only conditional authorization. It’s same for all drugs

The last 30 mins RSI showing overbought is a sign of spike !!!

Extraordinary meeting of the Committee for Medicinal Products for Human Use (CHMP): 20 December 2021 Share
Date:
20/12/2021
Location:
Online
This extraordinary meeting is organised to discuss the evaluation of the conditional marketing authorisation application for Nuvaxovid (also known as NVX-CoV2373), a COVID-19 vaccine developed by Novavax.

EMA will communicate on the outcome of the meeting.

The Committee for Medicinal Products for Human Use (CHMP) is responsible for preparing the European Medicines Agency's opinions on all questions concerning human medicines.

Committee for medicinal products for human use

December 2021 Chair: Harald Enzmann – Vice-Chair: Bruno Sepodes

16 December 2021, 08:30 – 15:00, virtual meeting/ room 1C

Meeting will ends in 5 hours, 6:00am EST

News or no news today, price will go up for the day

Reality check needed: CMC data package is not EUA filling to FDA. Anyway it’s a submission to FDA to pave the road for EUA filling next year, which is highly likely.

CMC package to FDA is not the same as EUA application. So there is no EUA application to FDA this year.

CMC package is probably for factory purity assessment

Today, the full results from PREVENT-19, Novavax’ pivotal Phase 3 clinical trial of NVX-CoV2373, a recombinant protein nanoparticle vaccine against COVID-19, were published in the New England Journal of Medicine. The paper, ‘Efficacy and Safety of NVX-CoV2373 in Adults in the U.S. and Mexico,’ may be accessed here.

PREVENT-19 achieved its endpoint of efficacy in preventing polymerase chain reaction (PCR)-confirmed, symptomatic mild, moderate or severe COVID-19 with onset at least 7 days after the second dose. The trial demonstrated 100% protection against moderate and severe disease, 93.2% efficacy against the predominantly circulating variants of concern and variants of interest, and 90.4% efficacy against COVID-19 of any severity during the time period evaluated. Solicited adverse events were predominantly mild-to-moderate and transient. Severe reactions were infrequent and there were no safety concerns related to vaccination.

PREVENT-19 evaluated the efficacy, safety and immunogenicity of NVX-CoV2373 with Matrix-M™ adjuvant in nearly 30,000 participants 18 years of age and older at 119 locations in the United States and Mexico. The trial included a blinded ‘crossover,’ ensuring all participants received NVX-CoV2373 without compromising Food and Drug Administration (FDA)-required safety follow-up.

Novavax expects to submit its complete CMC package to FDA for review by the end of 2021.

Reality check needed—Stan most likely will propose to increase stock shares from 75M to 300M if EMA et al approve Novavax. @ay888 needs to factor this high probability into the beautiful spreadsheet.