Replies to post #1705 on Iterum Therapeutics Plc (ITRMF)

[exwannabe]

Their letter seemed a bit worse that ours. Keeps me hoping ours was a 'labeling' issue.

The core of the letter was identical.

as part of its ongoing review of the company's New Drug Application ("NDA") for the control of serum phosphorus in adult patients with chronic kidney disease ("CKD") on dialysis, the FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time.

The letter stated that the notification does not reflect a final decision on the information under review.

It do go on to say:

While the FDA has not provided specific details regarding the deficiencies, the FDA noted that a key issue is the size of the treatment effect and its clinical relevance.

Which could be worse, but nobody knows the ITRM details yet.

The same key phrases were seen by letters to Cosmo Phamrma, Tricida,
TherapueticsMD and Acadia. All would receive CRL's shortly after.

Nobody knows yet if the issue with ITDM is fixable or not. But this boilerplate language does not suggest just some labeling issue.