Biotech Values

[iwfal]

SRPT

Under what statutory authority does the FDA have the right to redact information regarding SAE's related to approved drugs?

I certainly do not know the laws in this case - but my expectation is that:

a) The law only requires that the FDA make public 'known' issues.

b) Thus if there are any uncertainties then the company will have the assumed right to redact it.

The only question is how 'known' (e.g. how stat sig) does it have to be to unredactable by the FDA.

Also note that I wouldn't expect Woodcock to be too eager to push the envelope on this one.