merluc, most of us here understand the huge benefits of the Eden system in the DCVax-L mfg train and I agree with you the most logical reasoning for the MAA delay is it's inclusion. Whilst the small company resource level is a fraction of the BP's and a few other technical sections of a BLA/MAA can pose a challenge to them, 3+ years from datalock to submission in my mind, including the final delay, is a signal Eden is most likely included as concurrent development of this instrumental mfg device alongside the management of the closure, analysis and publication of the study allows for an appropriate development timeline.
The development and validation of the Eden system would have been the most complex undertaking in that period of time and would have consumed mostly different technical resources during this time. I am hopeful for a positive surprise or two coming starting with a shortened approval period, though I am aware of the risks of aggressive expectations here and the Eden system development may wind up the largest focal point of the MAA review. From what I see LP has been very deliberate, inclusive and patient in her pathway to this point and it is logical to me her pathway has included the Eden system. And I agree the Eden system inventor would not remain post completion of the development activity as I believe he is not a pharma mgmt person but an inventor.
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