HL,
While that sounds fair, if all four regulators agreed to this. Let's say that 100,000 patients in the countries represented by the regulators wanted the vaccine and had either already properly stored their tumor, or were prepared to do that on it's removal. Finally let's say that with Sawston operating as quickly as possible and CRL added the most they anticipated they could develop DCVax-L for was 10,000 this year. Even if it's 25,000, how are you going to get all the countries to agree on who's to get the vaccine.
Don't get me wrong, I don't believe that when approval is given here in the U.S. they won't immediately be able to meet all demands. The difference is whatever demand they can meet would be prioritized inside the one country. If all the European countries, the U.K. Canada and the U.S. approved, who would say how many in each country would get the available slots for making the vaccine.
I've got to believe that each regulator has some number in mind that's the lowest they'll consider in considering the commercial production facility adequate. If I'm right about that, Sawston wouldn't be considered adequate until it could meet the minimum number for all countries in which it was being approved combined. Clearly the U.K. has approved it, so it meets their minimum, but who knows how much more can it deliver, and will the U.K. be satisfied with all above their minimum going elsewhere if many of their citizens cannot get the vaccine.
If FlaskWorks Eden unit were approved, I believe that they could mass produce the Eden and it's disposable cassettes quickly enough to meet the demand in a matter of a few months. That cannot be said for tiny cleanrooms for manual manufacture of the vaccine.
I cannot say how the existing cleanrooms at Sawston operate, I would think that each one would have its own atmospheric control with no possibility of contamination from air, or anything else, moving between the rooms. I think all sort of precautions would have to be taken by people authorized to move from one room into another if it's permitted at all.
At times during my hospital stays I was in positive pressure rooms, not because I required it, but it's what was available. I don't believe it's nearly as complex as what's required in a cleanroom, but certainly adds to the complexity of treatment. Because my chemo caused diarrhea I often had to be tested for C-Diff, until I was cleared the nurses and all visitors had to put on new disposable gowns on entering the room, the Doctors tended to ignore it. I never had C-Diff, but did manage to get catheter infections which had to be dealt with. I'm only bringing this up to illustrate how high the cost would be of making each batch of the vaccine in its own tiny cleanroom. It can be done, and with the cost of the vaccine being in six figures it should be profitable, but it's a complication that can be eliminated by the Eden unit, I can understand why it's the company's priority to get it approved, and the regulators should see it that way as well.
Meanwhile, how do you decide who gets the vaccine if only a very limited number of all who want it can get it.
Gary
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