Iterum Therapeutics (ITRM)

[skitahoe]

Ex,

I'll agree if in the over 3 weeks from the time the FDA provided the guidance the problem can't be resolved. I don't believe the FDA would have done things this way if they didn't believe it could be resolved. If it couldn't be resolved I believe they'd have issued the CRL at, or before the PFUDA date.

No guarantee it will be resolved, but I believe the door is open to doing so. I believe that regulations required the company to announce what the FDA had said whether they believe it can be fixed in time, or not. It doesn't sound insurmountable, but certainly a CRL is possible and would result in at least a few months further delay.

I believe it's pretty clear that approval will eventually come, that's still the long term key. I can't say how low the share price may go in the intervening time, but believe the valuations people believe will come post approval are reasonable. Those who hold their shares and perhaps add on further weakness should be well rewarded after approval.

Gary