I agree with Lykiri and everyone here can also confirm what GZ stated to him by calling him. It is easy to try to interpret potential signals such as the change to 'cancer' indication on a pending product approval list as a potential broadening of the soon to be approved therapeutic indication, particularly when so much elapsed time has occurred. However given the complexities of the DCVax-L MAA coming from a bare bones resourced sponsor it is most likely safe to believe the MAA is for n&rGBM, which is fantastic to start, and with the manual mfg process, which is fine to start with knowing there is a fantastic upgrade just around the corner of approval.
As Lykiri states the change regs make it simpler to attain approval with the base process initially which is fully supported with development data and then to change to the modified process post approval with a supplement. The initial submission will contain significant explanations of the science behind the initial process and the mechanical components which execute the science. Then the change submission will only have to explain how the science remains intact and how the substitute mechanical elements perform the same basic functions as the original elements only with enhanced attributes such as quality, consistency, control or yield. This is why the change submission can be reviewed more rapidly, assuming the submission contains all required process development comparator datasets, which is a given.
This has been a journey like no other most of us have experienced. And MHRA I will say has not been as partnering as maybe expected, or maybe just not very efficient, which brings back memories of FDA prior to PDUFA fees and dates. The MHRA process is all but open ended and declaring to be caught up with reviews is not the statement it appears to be at first glance since the process is all but open ended.
Good luck to all. While it is never over until the RA sings approval, the more time that elapses means the RA has not found reason to turn down the application and it is obvious they have had more than sufficient time to turn over the rocks and discuss the findings with everyone. It is quite exciting to envision the dawn of such a wonderful new approach to cancer treatment!
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