BLA resubmission lacking?I take it the person hired for her knowledge of the BLA submission process to the FDA may have inadequatley completed the paper work.
FDA submitted an IR to the company and the information provided "constituted a major amendment because the submission contained substantial new manufacturing or facility information not previously submitted to or reviewed by the FDA, which entitles FDA to extend the review process by three months." per LMNL
Remember, you are only allowed one major amendment per review cycle. Here's hoping no more missteps