BL - I just like to give you my opinion as to part
Post# of 145439
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I cant see how anything may go wrong here since FDA reviewing this now , entire clinical part , and will give them the most updated request , what dose they want and what other supporting documents they will need if any .
Here we are in specific situation with BLA part 2 , normally FDA is not choosing the dose , company is , and company submitting the request ...
IMO of course...
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