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- Biophytis SA(* ) BPTS has actually started the very early gain access to application procedure in France for Sarconeos (BIO101) for the therapy of extreme COVID-19. .
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- .(* )The HAS gives very early gain access to in France after the National Firm for the Security of Medicines and also Wellness Products (ANSM) has actually provided its viewpoint on the anticipation of effectiveness and also safety and security.
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- BPTS shares traded reduced by 4.36% at $0.4010 on the last check Monday.
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A pre-submission conference with the French National Authority for Wellness (HAS ACTUALLY) is set up for March. The application for very early gain access to consent need to be sent quickly after to get consent in the 2nd quarter of 2023.
In the Stage 2-3 COVA test, the last evaluation of BIO101 showed a 44% statistically considerable decrease in the danger of respiratory system failing or sudden death in hospitalized people with extreme COVID-19, in accordance with a favorable Post-Hoc evaluation launched in November 2022.
A very early gain access to program was currently accepted in 2022 in Brazil to deal with COVID-19 people at a critical point in Intensive Treatment Units.
Biophytis remains to prepare conditional advertising consent applications in Europe and also the United State
.(* )The system enables the stipulation and also very early economic insurance coverage, on a phenomenal and also negative basis, of specific medical items that have actually not yet been licensed in a healing indicator.
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