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Re: biomaven0 post# 101117

Monday, 08/09/2010 4:34:36 PM

Monday, August 09, 2010 4:34:36 PM

Post# of 252255

But my guess is that their current attempt (unless they are very lucky) will be found to fall short, and they will need to try again - that would entail something like 2 years or longer before approval.



I agree...if they have to try again, 2 years seems appropriate to re-characterize, redo the manufacturing process, run immunogenicity trials and submit data, and for the FDA to complete their review process.

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