No actually it was true, in the context of what stage MSB understood the FDA were up to in the BLA assesement after just having sucessfully passed the manufacturing inspection, the only stage left was label discussions in accordance with FDA SOPs. They need to start at a particular time to meet the PDUFA date. Simples.
Ohh..... You thought the question was asked - what has to happen before FDA definately approves the product on the PDUFA date... oh - that was not the context or question. Wishful thinking for a non holding seller though
Ann: Quarterly Activities/Appendix 4C Cash Flow Report, page-44
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