Challenge

The Sponsor needed to find a way of dealing with unsolicited patient requests for its phase 2 study drug.

Challenge

The Sponsor needed to find a cost- and time-effective alternative to an OLEX study for providing access to the study drug, post-phase 3 clinical trials.

Challenge

The Sponsor needed to end a long standing OLEX study, that was set up after its phase 3 trials had ended.

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