We need the process to be robust so that when the findings are validated, there is a high level of confidence in that validation. Perhaps, I might just explain why it takes so long.
There are several stages for what is called the post-thaw study. These have to be designed carefully, the samples have to be retrieved very carefully, the testing has to be done very carefully and the third parties, the people who are validating and auditing this, also need to be satisfied that the samples are being dealt with in the proper manner.
A cord blood unit is not stored in an individual tank. The storage units contain many, many cord blood units. They were retrieved and stored under different conditions. So, the sampling needs to take into account the processing methods at the time of freezing. The way in which the retrieval is done has to be very, very careful because you do not want, in the course of establishing the potency of the unit, to then invalidate the potency of that sample. So, you have to make sure that there is no inadvertent compromise to the cord blood unit.
And the testing laboratory needs to then have the capacity to immediately receive the sample. So, you cannot ship the whole unit and then let them take their own time to process all the samples. Each sample has to have a specified time slot for receipt and processing so that they are not then subject to risks at the laboratory side. And there is a limited capacity available for the testing. The laboratories that can do this are quite limited. There is also no way to divide up a sample volume and send it out to different laboratories. There is only so much of the sample that is there. So, that small amount has to be dealt with in a very particular way. So, for all of these reasons and then, subsequently, the assessment and review of the results, it does appear that the one-year timeline is reasonable.
We understand the need, from the parents’ concerns, to expedite this to reassure people as fast as possible, but I think it is important that when the process is complete, that all who are involved have confidence in the findings from the process. So, I would ask for Members and parents’ understanding that it will take some time for us to go through this process.
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