Thanks, Manibiotech. The "Global Submission Dossiers"
4. Global Submission Dossiers: • If the submission is prepared for multiple regulatory agencies (e.g., MHRA, EMA, FDA, etc.), the dossier may include data tailored to the requirements of each agency, significantly increasing the overall size.
The Company and its consultants are working intensively to finalize this last key section of the MAA, after overcoming an unexpected delay in that regard. The Company strongly believes that after so many years of work on the DCVax-L program, taking some additional time to help ensure that the full MAA package is as strong as it can be is especially important since the Company plans to submit applications to multiple regulators.