ATL,
When you say there was enough capacity, are you saying that capacity is for conducting the trials, even perhaps expanding them, that's true. If you're saying that they can meet post approval demand, I don't believe that's the case.
To the best of our knowledge CRL doesn't have an agreement yet to utilize the FlaskWorks units and while they may have a great deal of cleanroom capacity, no indication has been established to get our FDA to accept their cleanrooms as how the commercial vaccine will initially be manufactured. I'm not saying that they do, or don't have sufficient capacity, but I believe their cleanrooms are largely tied up with products they're already on the hook to make, I don't believe that they can turn much if not all of it over the manufacture of DCVax-L.
Qualifying FlaskWorks is the name of the game and if the unit has now been approved for use by all the regulators it will just be a matter of time until sufficient units are deployed to sufficient facilities to make the needed vaccines, and those facilities fully inspected and qualified. I believe this can happen in a matter of months, but it's far from instantaneous and it's likely that our FDA may insist on things that other regulators are willing to do without. I believe that it's known the U.K. is satisfied with the FlaskWorks units, and perhaps all the other regulators agree, but I can't say I'm certain it's true. The U.K. will now be inspecting the entire Sawston facility to be certain they accept all that's found there, and if not that any discrepancies are corrected prior to it's acceptance. Again, it's impossible to say for certain whether other regulators will accept their equipment and capacity to meet their requirements. I believe it's pretty certain the U.S. would demand greater capacity, whether it's U.S. based, or not, to meet the higher demands expected here.
CRL is a very capable company, if our FDA accepts the FlaskWorks unit and the company has built a substantial number of units I doubt if it will take CRL that long to deploy them in facilities the FDA will approve of. To my knowledge we've never seen documentation that this relationship between NWBO and CRL currently exists. I believe it's very possible that it's all been agreed upon, but not yet formally announced.
Gary
