I disagree. The superior drug always ends up winni
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Posted On: 04/10/2019 2:39:16 PM
I disagree. The superior drug always ends up winning. It's possible the FDA or the EU won't think they need 300 patients -- or, they may decide that having a control group would be unnecessarily cruel given the well-known statistics of OM incidence in the chemo and radiation-treated population. The FDA is already moving in the direction of letting statistics from large groups of patients substitute for a control group.
Let's say that Galera managed to get their clinical trial done before IPIX does, and they get their expensive, inconvenient, systemic IV drug approved.
So what? It might help some people, and then when Bril-OM is approved, what doctor is going to prescribe a treatment that requires an IV and is (by current data) less effective than the newer, convenient Brilacidin oral rinse?
Let's say that Galera managed to get their clinical trial done before IPIX does, and they get their expensive, inconvenient, systemic IV drug approved.
So what? It might help some people, and then when Bril-OM is approved, what doctor is going to prescribe a treatment that requires an IV and is (by current data) less effective than the newer, convenient Brilacidin oral rinse?
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