banter and General Discussion, page-7006

And that is the billion dollar question that is on everyone's mind

A - It looks like it is most likley to be approved.
B - If it's not approved, currently it is really not possible to understand the reason why, and likely many people will consider the reason the FDA may give to be unworthy of causing the loss of life it to the children that non approval will likely cause.
C - Because B is unknown, the correctice action is unknown, and it's unknown if it will effect other trials or even other products, then it's really hard to second guess the potential downside.

I will say this though

The FDA said they wanted the potency assay linked to survival, and MSB have provided that data extremely convincingly with the above and below Median T cell suppression.
The fact that data is consistent across high MAP, Grade C/D, High minnesota, and supports the mechanism of action whereby the more inflammed a patient is, the better the treatment effect, we could not ask for better data ( unless the 85% survival turned into 100% survival - but then that would be an actual 100% cure )
Because of that demonstrated stong link, I don't think that part of the manufacturing is going to have any problems or effect other products or trials.... so my gut feel is any issue will be pediatric GvHD specific, without consequence to CLBP or GvHD in adults or ARDS.