Re: Jefferies - (1) it is making high-quality and safe vaccine at all its sites, (2) plans to file to the UK, EU and others within the next two wks
The last paragraph is the key to ex-US filings:
“ Moreover, mgmt imptly highlighted each EUA application is tied to a specific supply chain (i.e. FDA is only reviewing US supply chain). Thus, in our view, if there were issues with vaccine production in the US, it would be exclusive to that application. NVAX remains in discussion with the FDA on the CMC package and continues to plan to file in the US before YE, although we think there could be some risk to achieving that timeline. However, considering the oppty for NVAX is mostly exUS over the near-term, a delay in the US filing should not be material.”
That says any FDA issues are with US antigen production at FujiFilm in NC and TX or Matrix-M. Hopefully this report forces Novavax to be more transparent in providing updates on manufacturing by facility.