NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

Is that the same MHRA that gave approval almost 2 years ago to allow DCVax to be used in compassionate cases ? They would look pretty silly now if they didn't sign off on the MAA. What would all those patients think who have been treated over the last two years with a drug that wasn't approved?

2 years ago was the facility approval for Advent's Sawston ops for GMP manufacturing.

As far as Specials (what you incorrectly call compassionate access), Advent has been selling -L under that program for 6 years or so. But that program is for drugs that have not been approved and are not on an approval pathway. The program makes no validation of any drug wrt safety or efficacy. It is a program that allows a doctor to use anything they want for patients with special needs subject to restrictions., The MD must take responsibility for care. The drug cannot be advertised. And the manufacturing must be GMP.

So yes, MHRA did say that Advent has the ability manufacture -L per GMP. They have said nothing to even imply safety or efficacy.

The concept that drugs are allowed in some sort of compassionate access means they should be approved is seriously bogus.