Replies to post #1533 on Iterum Therapeutics (ITRM)

[zzaatt]

... FDA sending same exact letter to other companies in the past and shortly after issuing CRL for either safety or efficacy reasons?

To see a pattern of behavior on the part of the FDA, you need to give a statistical sample of companies that were either ultimately rejected or approved after getting the "same exact letter". Let's say a year's worth of letters.

Until you can do that, you have no argument!

[eightisenough]

me--we were ALREADY IN LABEL DISCUSSIONS---all your other co. receiving a crl WERE NOT. Hence cannot be anything other than a label issue.

major distinction.

Also other co. did not have their adcom scheduled, then postponed, then told UNNECESSARY.

major difference.

I hope you understand now, why the argument is irrefutable.

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