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Wednesday, December 10, 2014 12:26:54 PM
I see the market is yawning over the Prurisol news today. Interesting that a $5 billion drug receives only little buyer notice even though the 505(b)(2) pathway might have it on the market by end-2016 or earlier. As noted in the PR, the testing will require no long-term safety data since this data already exists. What this means is the protocol for phase 2 and then 3 can be short-duration study of short-term outcomes.
What do we already know about P? We know that it CURED psoriasis in xenograft studies. If it works the same in human trials, they will know it is a possible cure within 6 months of the start of the Phase 2 trial. How this will influence the inevitable phase 3 design will be interesting to see a year from now.
I'm looking forward to reading the protocol and duration of treatment and follow-up. Expect it to be very much like the B-ABSSSI Phase 2a.
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