Gary, in the October 13, 2023 update whose subject was the delay of the MAA
submission, LP stated that it was important to delay the MAA submission in order
to upgrade the application so as to improve its acceptability by other regulators.
I interpret that to mean that the original MAA version would have been accepted by
the MHRA but not necessarily by other regulators (e.g. FDA).
I am now guessing that the original MAA did not include the validation of the
EDENS System but that would not have been a reason for MAA rejection in the UK because
the smaller UK demand could still be satisfied by the manual (artisan) manufacturing
capacity. However, that capacity was insufficient when it came to cover additional, more
populous areas (e.g. USA). I am therefore guessing that what LP called the end of the
delay was in fact the accumulation of sufficient data that validated the utilization of EDEN
and thus made the MAA more potentially acceptable in many jurisdictions.
Bottom Line: I believe that the EDEN automatic manufacturing system is on board.
"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."
