Hyperopia, how high do you think the price is of manually making the vaccine?
I would think that the most it could be would be for a person having to be in the cleanroom virtually every hour, lets figure it's 8 days 24 hours a day with a few added hours let's say it's 200 man hours. I don't know how much the cleanroom personnel typically earn, but I think if we used $100 an hour it would be reasonable, so the manual labor portion of the cost would be $20K.
I don't know if the cost of supporting the cleanroom operation would be higher or lower than FlaskWorks units, but for discussion purposes, lets say it's $5K higher. There would be costs involved with FlaskWorks as well, but for talking purposes let's say the manual vaccine is costing $25K more.
The question in my mind would be, knowing that FlaskWorks would be coming in the future, would the company agree to supply DCVax-L at the same price, let's say $150K for talking purposes.
I believe that the company would agree to a constant price and permit the profit per dose to be lower until the FlaskWorks unit was approved, this would be especially true if the alternative was not selling or gaining approval of DCVax-L at all until it could be made with the FlaskWorks unit. I believe that this would be true for the U.K. alone, where substantial small cleanrooms exist and the total patient numbers are smaller than elsewhere. The initial approval in the U.K. should speed the process elsewhere once the FlaskWorks units are approved.
It would also be my belief that if the decision was made to build the number of small cleanrooms needed to initiate commercial operation in the US and elsewhere that by the time it could be done the FlaskWorks unit is likely to be approved and can be installed in existing sites easily. The cost would be substantial, and the likelihood is that by the time the units were completed and passed inspection the FlaskWorks units could be approved.
I don't know how close what I said above is, I believe it's on the high side of what the manual operation would cost. I don't know, but believe that one person could work on batches in more than one cleanroom at a time. If I'm right about that, and say they could work 5 batches at a time the added cost for each would only be $5K, that makes it even more reasonable to accept the lower profit with a fixed cost for each batch whether made manually or by FlaskWorks provided the regulators permit it.
Gary
