What are we actually waiting for in filing the BLA
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Posted On: 09/04/2019 4:01:24 PM
Re: Bored Lawyer #7253
What are we actually waiting for in filing the BLA? It is my understanding the FDA just has to say go ahead and file, the paperwork is all ready to go. If there is a delay it is purely because the FDA has not given the go ahead? Am I correct? I guess a delay might be that the FDA need more info, that they don't know about?
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