Replies to post #756057 on NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

MHRA has moved slowly, yes, but not irrationally slowly given the novelty and regulatory complexity of the case. They are balancing safety and precedent because approving DCVax-L opens the door to future ECA-based approvals. The trial may be cut and dry for you but its not for the real world because of ECA comparison without individual patient data, randomization of control patients to treatment and changing endpoints.

NWBO longs are too easily forgetting that the DCVAXL MAA submitted and the SAP/SPA its based on is controversial. The MAA submitted is being/has been so far, highly scrutinized (I heard that from my good source) and therefore until the MHRA approves DCVAXL, the market will consider NWBO a very risky investment.

[beartrap12]

This is why I believe the RA is waiting for something to come onboard that will allow NWBO to handle the overload of patients who will want this treatment right away...something....like... EDEN...?
With EDEN our entry into commercialization is likely to be much smoother than without it.
Not saying I want us to wait for EDEN. Just pointing out the obvious.
Also less expensive for MRHA and the UK.

Flipper:

“One thing that bothers me immensely about the process is, that despite the fact the agency knows this technology inside and out, the agency supposedly highly prioritizes this cancer indication, supposedly prioritizes this amazing and unprecedented type of safety profile, know its potential (combos/versions), understand its impact on long term survival, have over a decade experience with the therapy in compassionate treatment, picked through and certified all relevant manufacturing, understand patient need, and despite all that, they’re incredibly slow.

Patients are waiting.”