Progress for Next week:
1) The IP Waiver is dead - Mercel will never budge, Macron already threw Biden under the bus, Mario Draghi is against it. Several countries - UK, Switzerland, Canada, Brazil, Italy (Draghi), Norway are all against the waiver. The IP waiver will never pass, and US will need to fasttrack Novavax and give more vaccines to India.
2) EU EMA Meeting May 7, 2021 - The EU EMA met last Friday on Covid vaccine authorization and safety issues. You can look it up their website. Progress for Novavax as the next vaccine in line for EU authorization. German news said Sputnik can't meet the demands of the EU EMA for safety, so that's dead. Novavax-EU contract is getting signed soon, and right after that EU will award authorization to Novavax.
3) WHO Covax Meeting May 7, 2021 - They also met last Friday to discuss Novavax. It's on the WHO website. WHO took 11 days to approve Sinopharm after meeting last April 26. We're also set for WHO EUA and we already committed to 350 million doses delivery for July 1st (the beginning of Q3).
4) UK EUA - GSK already produced some batches of fill and finish in April and so Novavax is fulfilling the production part needed for approval.
5) US Phase 3 Data - should be coming next week. The delay seems to be due to them parsing efficacy for all variants (Uk, SA, California, New York, Oregon). It's also parsed for various race (white, black, asian, latino, etc). The data set will be very rich for the FDA and WHO - probably the most comprehensive to date for all variants.
6) US FDA - After US Phase 3 data is revealed, FDA filing and approval will move faster.
7) South Korea EUA - Moon has promised a special team to fasttrack Novavax approval while Stan visited him.
Earnings is not relevant - we just need updates for future events.
Mal schauen, wann wir den ersten Domino Stein umstoßen... Allen Investierten eine erfolgreiche Woche! |
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