What is meant by an out of spec CAR-T product?

What is meant by an out of spec CAR-T product. 
So in car-T cells because we're taking your T cells out, we're putting a new receptor in there and then we're growing them. The FDA requires a lot of different check marks in terms of that quality piece and the quantity piece of those car T cells. So based on the clinical trials, all the the different sponsors had to come up with checklists of what would be what would be a good product that we should give patients versus if it doesn't fit those quality specifications, then we call it out of spec and sometimes the cells. Right because we've taken them out, it takes 4 to 8 weeks to make them. And we get to the point where finally we can treat this patient and all of a sudden it comes back out of spec because what we call viability for those T cells, that it's supposed to be 80%, but it was 79% or because the number of CAR-Ts that they have on each cell was off by the tiniest amount, there has to be a cutoff. But if it's close enough, we know those patients are probably going to still do really, really well and benefit from those. And they need the treatment that we say, you know what, risk benefit, yes, it's worth it. This is not a major. So if someone had an infection, it like when they were doing the testing and there was bacteria or a virus, we don't do those. Obviously, there's no way we're going to get those cells. But really those that are really close to what those specifications should have been, but they just missed it by a little bit. And usually the company will talk to the doctor and say, do you want to move forward with this or not? And then most of us will say yes, because we really want these, especially when there's a, you know, limited number of slots. And if they're close enough, we know that it can still, you know, make a difference for those patients in terms of their outcomes. out of spec CAR-T products are becoming more and more of an issue because the bandwidth for for CAR-Ts is widening so more patients are getting access to this novel treatment out of spec simply means that they did not meet criteria established by the FDA that would suggest that they're going to have a response rate that we would all have seen in the prescribing insert so out of spec could mean that they don't have enough viable cells, that these viable cells could have problems inherent in them, that they weren't able to make them in a certain time periods and benchmarks that were defined in some of the processing, some of these out of spec problems are enough so that you should call off the whole procedure because the cells are unlikely to be helpful to the patient, such as there's a very small percentage of car T cells that are viable and that would be available to be infused to the patient if it is below the lowest level tested in phase one clinical trial. Some of these definitely should never be infused into a patient, whereas there's some out of spec characteristics where there's just a few percentage points below the minimum. But I think it makes sense to infuse those. Some of the problems with the out of spec CAR-T products is that they often require a companion clinical trial to be ongoing at the at the center where you're going to receive these CAR-TsAnd sometimes the organization of that can be maddening and also eliminate the possibility of getting the car. CAR-T So the entire the entire process is quite a challenge. But just being out of spec doesn't always mean the procedure is not going to happen.