Unlike some posters claim here, the issue with FDA is not the efficacy of cells, it is clearly the potency assay used by MSB in the trial. Whether or not all batches used in the trial have similar potency in altering immune response or we had variation in the potency of cells from batch to batch. FDA cannot approve a treatment if it believes all patients will not be treated with reasonably similar products.
I don’t know the details of what exactly bothers FDA about the potency assay, but I do believe that the company will be eventually able to address this problem. Don’t forget the cells are safe and effective and these two are the most important factors in any medical treatment.
We as investors have limited information and we should not invest in any company if we do not trust the company directors.
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