NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

Daniel,

I tend to believe the FDA will want the FlaskWorks unit before they'll approve a BLA, they'll consider it, but they'll want to know that the company can meet the production demands on their approval. I could be wrong, CRL might commit to more production using clean rooms than I'm crediting them with, but I suspect that FlaskWorks is the key to the future, and it's one that the FDA could require before granting approval.

The thing is, I believe that the company and FDA will discuss this before a BLA submission and the company will know what is anticipated. The BLA can be submitted before actual approval to use the FlaskWorks unit if that approval is anticipated during the 6 month evaluation period. If it fails to happen the FDA will delay until it does.

The U.K. and perhaps Europe will be satisfied to begin with the facility at Sawston operating multiple clean rooms for approval. The U.S. will certainly follow in time, but with FlaskWorks, if it's approved in time, perhaps we'll all be wrong about the time to approve FlaskWorks unit and the FDA will approve as quickly as everyone else.

Gary

Gary