Replies to post #1782 on Ampio Pharmaceuticals Inc (AMPE)

[drkazmd65]

Yeah - that was amazingly dumb.

the Company should have sought FDA's agreement on these changes prior to analyzing and unblinding the data

My only real question - in whether they can salvage these data in some way to please the FDA - by hiring some independent CRO or Statistical Consultant group to give them the raw data, blinded again to that new CRO, and have them redo the analyses from scratch.

If possible (and it may not be in the FDA's playbook) - it would be less expensive that having to redo the entire clinical trial.

Ughh,..