So can we call a end to the down rampers saying that effecacy has not been deminstrated. The FDA have rulled.
Its about time however that MSB and the FDA understand that todays cells will not be the same in every detail. That is why maintaining a registar is so important. By the data generated from the registar we can proof ongoing effecacy , individual batchs would then be the best available MSC for ongoing research into IBD and the many other indications.
We should also be pushing forward for full approval in children with MAP above .28 with the condition of the tested product by batch been withdrawn from market if a significant responce at say 7 and 14 days had not been deminstrated by MAP change from bass line.
We have the best MSB by far, the general run of the mill product may be better than nothing however ours has now been shown to be way better. Perhaps those inhouse MSC products need to be replaced.
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