I listened to the ASM attentively, though I did not take notes. Here is my take:
-My sense is that this is a team that has been surprised by how slow the MHRA has been in its decision regarding DCVax-L.
-They went to the UK first because of the long history there; first PIP in the UK; 150-day accelerated process. I get the sense that had they known it’d take this long in the UK, they might have considered submitting elsewhere. But it is what it is.
-With that said, as LP stated, this is also a team that is “gratified” with how involved MHRA is in their application. It seems MHRA is VERY active/involved with the application.
-LP noted that consultants have also been delighted with the MHRA responses and take it as a good sign. There was mention that NWBO is not alone in this delay, and other companies are waiting similar lengths.
-If/when approval is granted, it seems NWBO would go to Canada or the U.S. next with an application. LP mentioned that the regulatory landscapes in all potential target markets have embraced new frameworks, such as ECA and RWD, and that the forthcoming MHRA RWD/ECA guidance is a big deal.
-Kalinski is returning to Pitt, and it sounds like NWBO will be making DCs for his trials and using the Pitt facility as a hub for compassionate use cases across all solid tumors.
-There is strong interest from host sites for a PII of direct, but resources need to be focused on MHRA/Sawston for now. It sounds like the PII is for Ovarian cancer.
-Management would likely expand exponentially if/when approval happens. Consultants would become in-house.
-They are ready for the product launch in the UK now, should it happen. The grade B is enough, and they don’t need NICE reimbursement for the initial launch.
-They do not want to dilute, but mentioned the expanded share count gives them room to enter a major financing deal, which, it seems, might already be in exploratory phases should approval occur.
-Overall, I get the sense that this is a company that could and perhaps expects to experience rapid transformation if/when approval happens. It absolutely kills me how long this has taken. I think you could very easily say the same for LP and co. But I couldn’t help but feel a strong sense of reassurance and be reminded of the huge potential here.
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