I think the FDA would see differently that a phase 3 trial would need to be run still and it would need to collect safety data.
I seem to recall David Foster mentioning he expected, or received info that the FDA would want a field trial for a phase 3.
there would be no expectation people are infected with real dengue, but just like the two phase 3 trials of the two different currently approved dengue viruses have demonstrated, it’s possible to run a trial with tens of thousands of patients for a dengue virus in the field.
if a challenge study is accepted for phase 3 with an attenuated strain and is funded by the army, all the better. But I dont expect it.
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