Actually it usually takes a year to approve a drug after an nda or bla is filed at a minimum.
Bupp kept on saying that the BLA is open. That is very important. That means that when they file this additional data it may take only 3 to 6 months to file the bla because all the other information that goes into preparing an fda like tox studies and the like have been reviewed already. The only thing that would need to be looked at is the current trial data.
That is a big issue that was not conveyed during the call.
I am going to call the company to make sure I am right.
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