I'd like to discuss the subject of capacity from a different prospective. As I understand the trial, those who received initial dosing didn't get it for some time after surgery, I believe that may have been 3 months, but I'm not certain. As for cross overs, they got it 3 months or more later as I understand it. When we learn the trial results I expect that we'll see that many cross overs did have benefits, but I would expect that sooner is preferable to later for maximum benefits.
If the above is true, I believe you have a scenario in which production can catch up with demand as long as proper preparations are made at the time of the surgery. If the tumor, or tumor lysate, can be properly preserved at the time of the surgery I don't believe there is an immediate need to make DCVax-L. I'm frankly uncertain if it's best to do the leukapheresis before the removal of the tumor, or just before making the DCVax-L, or any time in between. If it's of greater benefit to do it before the surgery, it too can be done and preserved.
As I understand it, with a cell line it takes just over a week to make the DCVax-L, it may be slightly faster with the Flaskwork device. What's important is that the necessary products are preserved properly, then production can be scheduled as ever greater capacity is being added post approval.
I frankly believe that CRL is capable of rapidly gearing up. While it's very possible that hundreds, or even thousands of tumors will be properly preserved in anticipation of approval, the key will be, can we get them into the roughly one week production cycle while they can still be of benefit, perhaps up to six months or more after surgery, depending on the condition of the patient at that time. I believe that CRL has substantial clean room capacity, the question is, how much of it can be devoted to production of DCVax-L.
To me, the joker in the deck is the Flaskwork device, and the regulators willingness to use it if capacity is lacking. Let's say we had the capacity to handle 900 patients, but 1000 patients were fighting for it. 25 Flaskwork devices and 100 cassettes could make up for the lacking capacity in one month. Would the regulators permit the 100 patients to be treated in a timely way and work on certifying the devices simultaneously, or not. I tend to think different regulators will act differently, but that at least some will benefit from the use of the Flaskwork device.
Once it's determined that the Flaskwork device is qualified to make DCVax-L, production capacity problems should be eliminated.
Gary
