Replies to post #769345 on NorthWest Biotherapeutics Inc (NWBO)

[jesster64]

Good question. I believe the standard of investigation remains the same, as thorough as possible, but it varies on the use of drug that is requesting approval. I have to ask is submittal of 1.7 million pages normal? Once the approval comes for glio, I believe it opens the floodgates for use on many other types of cancer, so I believe they are making sure the foundation is secure on which they plan to build future treatment approvals on.
But not being a doctor, I could be entirely wrong. Other than something is wrong, its the only explanation that makes sense to me.

[jesster64]

It is also possible the original application was not thorough enough, but MHRA saw enough in dc-vax that they are helping NWBO across the finish line. Again, I have no proof and its pure speculation, but dc-vax is being used in compassionate care cases allready, so they must see something there. I do not want to be invested in a company that sets the record for taking the longest approval time, but here we are

[Steady_T]

MHRA standards are the same. The novelty of the approach and the complexity of the process will require MHRA to spend more time on learning and understanding the potential issues.

The way the trial was conducted is unusual. That alone will generate some questions and discussion. Then there is the biologic process which is novel and will also generate questions and discussions.