BL - I just like to give you my opinion as to part 2, clinical part ..

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...