Friday, February 07, 2014 2:34:36 PM
Now lets look at the still possible outcomes....make up your own odds.
OA...The drug is released....go straight to the NDA.
AA...The drug is released....But you still have to do that bridging study while you are selling the drug.
BTD...You have to do the bridging study before it gets released.
Any of those three are slaps on the back and a "well done boys".
Now what does a BTD mean if all the data is there and no bridging study is required...I think that means OA...I may be overstepping here and others should correct me if I am seeing this wrong.
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