They are discussing big pharmas’ lawyers lobbying (again) to get the BLA rejected. They did so successfully on MSB’s first attempt and are trying again.
The problem this time was that they jumped the gun and objected too soon. Their mistake was to think that the data submitted to the IND file was the final BLA submission which it wasn’t. That happened later and made them look incompetent.
Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-986
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