- BioNTech (NASDAQ:BNTX) and Pfizer (NYSE:PFE) initiate a rolling submission to the European Medicines Agency (EMA) for BNT162b2, the lead candidate from the companies’ vaccine development program against COVID-19.
- BioNTech and Pfizer plan to work with the EMA’s Committee for Medicinal Products for Human Use (CHMP) to complete the rolling review process to facilitate the final Marketing Authorization Application (MAA).
- As part of the review, the CHMP has begun evaluating data generated in pre-clinical trials. The formal MAA submission could be finalized following the rolling review process, pending demonstration of vaccine efficacy and safety and confirmation from the EMA.
- https://seekingalpha.com/news/3620006-biontech-pfizer-begin-rolling-submission-for-covidminus-19-candidate-bnt162b2-in-europe
Tuesday, October 6, 2020
BioNTech, Pfizer begin rolling submission for COVID-19 candidate BNT162b2 in Europe
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