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A biopharmaceutical company focused on creating differentiated, value-added vaccines that improve upon current preventive options for a range of infectious diseases.
The investment premise for this and a number of the speculative H1N1 stock plays are based on two faulty premises. 1] That there will be a substantial shortage of vaccine from the already contracted Pharma including GSK, Sanofi, Medi. 2] that these vaccines will be purchased on EUA without the need for additional clinical trials. IMO there will be sufficient vaccine come november and even in the absense of sufficient quantities, there is no evidene that the FDA will permit the use of unaapproved vaccines. IF you look at the recent VRPAC presentations from the FDA you will see that they are quite clear the path to approval is through the amended use of an existing seasonal BLA. THere is no chance that NVAX or any of the other speculaticve calls such as VICL, HEB, INO etc. will have approval by the time a vaccine will be needed. THese will be under real preasure come October when the approved vaccines ship.
My premises: 1. FDA = USA (and some lingering supra national influence outside of the US). 2. USA= about 300 million people.3: Planet: 6 billion who will mostly not have access to a vaccine and yes people have money to buy a vaccine outside the US! Look at the deals Novavax is making for H1N1 and the US doesn't seem very important in their business plan.
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