Replies to post #428078 on NorthWest Biotherapeutics Inc (NWBO)

[sukus]

Agreed Bright Boy.

[Dr Bala]

I think your buddy is right. Great news all through.

[FeMike]

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!!!""

Pump the brakes on this logic. This certification is in no way, shape, or form tied to DCVAX in that way.

They are allowed to produce DCVax under this cert. This is not a certification specifically to produce DCvax.

It is for production of:

Human Investigational Medicinal Products

Under which DCVax falls.

[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.

[Umibe5690]

BB:

Please refer to my #425650:post where I said the same thing over a week ago. NHRA GMP cert is a precursor of NHRA marketing approval.