NorthWest Biotherapeutics Inc (NWBO)

[FeMike]

Talking to a UK buddy of mine that told me the Sawston certification all; but guarantees UK approval !!! I said,"Are ya sure??" He said," DO you really think that the MHRA would certify Sawston to manufacture a vaccine(DCVax-L) that did not work and damaged people in the process!!!""

You do realize what this statement is claiming right?

In order for this to be true, it must also be true that MHRA reviewed the results of the Phase III trial and determined for themselves that the drug is safe and effective.

How else could they possibly determine whether DCVax 'did not work and damaged people in the process'? Are you really trying to tell me that MHRA is the first regulatory agency to review and approve DCVAX-L?

Neither the results of the trial, nor the efficacy of the drug, are part of the certification process. Period.

The certification allows them to produce DCVax, yes, and makes approval much more likely, also yes.

This is very good news. But the claims you (and your friend) are making are just flat out wrong. CGMP certification makes sure you can safely and consistently make the drug category you are applying for. Nothing more.