Very, very unlikely. Possibly if we had a successful confirmation trial where everyone who improved at week 5 continued to improve months later as happened last go around, it could be monitored in a successive trial but close to no chance in this upcoming trial IMO.
Rarely is actual interim data released by a company. Some trials have a Data Safety Monitoring Board review interim results (at a predetermined time) for futility and safety issues, both of which are reasons that a trial can be halted. But it's extremely rare to see a trial halted because the drug arm is so much better than the placebo arm.
I don't anticipate a DSMB interim review of our data for the upcoming trial. I don't think we had an interim look during the last trial, and the safety is pretty well established.
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Cyosol: thanks for the extract of info from the 10k report.
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