Wednesday, June 28, 2017 8:48:05 PM
8 months, yeah.
Perhaps they will dose the first patient in 8 months. But I would put 8 years as a more reasonable estimate for approval.
The trial will not be pivitol.
Look at the trial you linked. It used Overall Response Rate as the primary endpoint. The FDA accepts this in a single arm trial, they do not accept OS or PFS. The reason is obvious.
But Direct has yet to show even a single overall response. Makes that endpoint useless.
The trial being launched is another P1/2 level trial. Looking for signs the drug might work. If it shows such, they would launch and actual pivitol trial.
In 16 years this company has not produced results on a single trial. And you expect them to run 2 sequential trials in 8 months.
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