Replies to post #1522 on Iterum Therapeutics (ITRM)

[skitahoe]

Thanks Zzaatt,

I believe what's very clear is that the FDA will eventually approve the drug, whether this time is the charm or not, it will happen.

I've never liked the delays and costs imposed by the FDA, but I think it's clear that once the company agrees to their terms, it will be approved. Hopefully that's possible in the next few weeks.

I have seen many approvals delayed for products I was certain would be approved, not a single one failed to ultimately be approved. Sadly the FDA never seems to care how much their actions cost the drug developers in time and money, and more importantly how many patients have to suffer, and in some cases die, because the FDA is unwilling to be more flexible.

What would be the harm if the FDA said, approved, but it's conditional to making labeling or other changes. I believe the changes could easily be made knowing that when they were the product would immediately be on the market.

Gary