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Post by marriott on Jun 30, 2021 21:25:46 GMT
During the last conference call held
Pathway to Regulatory Approvals :
European Medicines Agency UK Medicines and Healthcare products Regulatory Agency
Australian Therapeutic Goods Administration
New Zealand Medsafe
Health Canada
US Food and Drug Administration
Republic of Korea’s Ministry of Food and Drug Safety* *SK bioscience initiated regulatory submission process in collaboration with Novavax
World Health Organization
Company goals :
Short-Term - next six months
• Emergency authorization of NVX-CoV2373 in multiple markets • Expansive distribution of NVX-CoV2373 Protection against variants
" Regarding our regulatory pathway in the US, we are in ongoing discussions with the FDA to align on the data required for initiation of EUA and continue to provide information to our open IND application. At this time, we expect to complete our EUA filings in the second quarter . Did not meet timeline . Near-Term - next 12 to 18 months
• Leveraging NVX-CoV2373 as a booster and for seasonal revaccination • Production of variant strain vaccine(s)
Long-Term - next 36 to 48 months
• Licensure of NanoFlu™ / NVX-CoV2373 combination vaccine • Continued development of robust pipeline
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