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Wednesday, January 25, 2017 5:22:07 PM
The immediate catalysts are BTD and ODD Approval and primary endpoint completed Adjunct P3. Those are February or even March timelines. Status on P3 Mono is also lurking. February is big because there is a strong possibility that some of these catalysts are met prior to Feb. 16 which would garner BP's undivided attention at CROI.
The fact that we have what looks to be 100% of the patients that have completed the Adjunct P3 opting to stay on Pro-140 is great news. The pace of enrollment is due to the thorough screening process that is being executed by Nader to insure optimal results- with only 30 patients they can't afford errors that allow an unsuitable patient into the study. From the grandstands this all looks simple...it is not. It's called the FDA Gauntlet. Getting it right is far more important than getting it done fast but carelessly and being sent back to the drawing board. You don't really get a second chance.
When there is no news people focus on the SP and negativity sets in with all that COULD go wrong. Don't forget about how much has a very high possibility of going right. Pro-140 is highly effective and very safe with basically no side effects. This will all come out in the P3 data.
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