Iterum Therapeutics Plc (ITRM)

[exwannabe]

I went through the ADCOM material a few weeks ago, but mainly from the pov of understanding what the FDA analysis was. I am very comfortable the FDA is willing to bless sulo as being safe and effective, the only open question is how to try to restrict use to avoid resistance.

Replaying it and listening more closely to the details of the discussion of creating resistance, I can understand how this is a tough issue to tackle.

The proposed label by ITRM (designated susceptible micro-organisms) is clearly a non-starter. Nobody at the ADCOM could even say what that means, and even if they could, the family doc is not about to call for a several hundred dollar test just to prescribe a cheap pill that almost always "works". Alternatives such as use after failure or use for resistant bugs had no supportable data,. Certainly a problem for the FDA, but they will find some label that expresses the concern.

I would be certain they will exclude use as a step down following IV treatments. I suspect they will somehow say use for cases where the doctor finds treatment via augmenten is not suitable.

I would not at all be surprised to see the FDA go off the farm and issue a black box against abuse due to risk of generating carbo-penum resistant bugs.

I wold be certain there will be a REMS and/or post approval study on these issues.

On the broader issue of antibiotic management, I was encouraged everybody took it seriously. I was discouraged that most all felt the community docs will broadly ignore it and take the easy way out.

.