Si did mention in a Q & A that he believed the FDA wanted an additional potency assay.
As far as I know, there is no information on what that essay is. It could be Inf Gamm for all I know. It simply has not been spoken about. That does not mean, it is not Inf gamma as JB keeps suggesting.
Back to my original response, in any case I cannot see the FDA reviewing a BLA that demonstrates a high degree of efficacy, where efficacy correlates to a high degree with the potency assay, and high survival to then turn around and deny approval based on a tack on "whatif" question.
Ie... whatif something happens that they currently have no evidence to proove will or even could happen.
Big difference between what Klikner have done in a test tube, and what MSB have done in sick children with gvhd. Msb have prooven TNFR1 is linked to treatment efficacy. Klinker has not. Its like MSB demonstrating the sheep disc regeneration in a sheep, which has appeared to not match what happened in human the trial.
for Inf gamma, maybe tnfr1 priming is linked with inf gamma since they both act on the process. That is to say, maybe it is extremely unlikely to find low activity of inf gamma where there is high activity of tnfr1. Maybe tnfr1 in high activity does not require inf gamma high activity to work ... none of this has been proven. Maybe msb know the answer, and that is how they selected their potency assay. We both don't know.
MSB Price at posting:
90.5¢ Sentiment: Buy Disclosure: Held
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