Replies to post #90487 on Biotech Values

[apljack]

JAV:

Dew, does your comment apply to analyses that have not yet been submitted? I'm not certain that JAV has submitted the data on Ereska. Does this make a difference?

It would seem that if JAV found a data or computational error, this should be correctable.

I guess the only recourse, if not, would be for JAV to sue the vendor who made the mistake.

aj

[AlpineBV_Miller]

the FDA does not accept post hoc data corrections in an applicant’s favor.

The key part is there in bold. The FDA freely uses post-hoc data to trash applications and bristles when you point out to them the contradiction.