georgebailey, I do agree that NWBio would need to incorporate the Flaskworks devices into the DCVax-L manufacturing processes as soon as possible, in order to meet patients’ demand if tissue agnostic approval is granted.
I also believe the regulatory authorities do understand the concept of “which comes first, the chicken or the egg”. In the case of NWBio and DCVax-L, the question would be, “which comes first, approvals to generate revenue and capital, or adequate manufacturing capacity to meet future demands?
NWBio, and it CDMO partners (Advent & CRL), will need to invest $100 millions, if not $billions in capital investments, to build more Flaskworks devices and facilities, to expand DCVax production capacity around the world, in order to meet future demand for DCVax, if NWBio is granted tissue agnostic approvals.
The only way that this can happen is, NWBio has to get those regulatory approvals first, then they will be able to afford to meet worldwide demand for all or most solid tumor cancers.
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