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InTheTrenches

08/09/10 4:34 PM

#101124 RE: biomaven0 #101117

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.