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Novavax Nears Vaccine Approval, Manufacturing, Sales And Profits

Summary

Novavax is poised to launch its first vaccine as Phase III testing nears completion.

Both the FDA and Novavax are ready to move fast once the Phase III trial is completed.

We estimate Novavax’s potential vaccine revenues, and company valuation.

Novavax (NASDAQ:NVAX) is poised to become a vaccine manufacturer with sales and profits, pending FDA approval of its first vaccine-an annual shot to prevent RSV disease in older adults.

Both the FDA and Novavax are ready to move fast once the RSV vaccine's Phase III results are in (expected between July and September). Novavax may then submit a Biologics License Application (BLA) to the FDA on a rolling basis, under a "fast track" process that the FDA announced in late May; Novavax hopes for a fast track FDA review of six months versus the standard ten months.

Novavax already has manufacturing capability to meet demand for RSV vaccine in the U.S. market for the launch year and two years thereafter. This week Novavax signed a lease for space near its headquarters for expanded manufacturing capacity. In anticipation of FDA approval, Novavax is taking the following additional steps to ensure a successful launch:

  • Educating the health community about the risks of RSV infection, through the website discoverrsv.com and with booths at major conferences.
  • Planning its outreach to health professionals who treat older people (e.g., those who administer flu shots).
  • Planning its Medicare pricing negotiations, since Americans over 65 are covered by Medicare.
  • Holding discussions with global drug firms that could market the vaccine outside North America.

Here's the upcoming sequence:

  1. Phase III testing completed by...

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