Hi Tryn2:
Since no one else has responded to your good question, I will take a crack.
No, this is not marketing approval. It is manufacturing approval, granted to the factory for the manufacture of advanced medical products, cell and gene therapies for human use including but not limited to murcidencel.
This is a big feather in the cap for Advent Bioservices, which operates the factory in Sawston, UK. And it bodes well for murcidencel (DCVax-L) but there is still another regulatory hurdle to be overcome before doses can be sold on the open market.
To sell DCVax-L on a large-scale, commercial basis (greater volume than in clinical trials or compassionate use ("specials" in UK parlance) cases, the owner of the product, NW Bio, must first obtain marketing approval for the product. This has not yet been granted.
That is how I would answer your question.
Would other (smarter, more experienced/knowledgeable) posters on this board agree with this answer?
-- OJ
Market Data 
Markets 
AI
