EPP was the proof of concept clearly.
The safety and efficacy data is accumulated now for 20 years.
no alternative treatment is available. The patient return 90pct.
All other orphan drug trial efforts are supposed to stay small as there is only a few patients to treat.
The low penetration is also due to the regulators and payors. Clinuvel doesn't want to sell scenesse for peanuts.
Next in line is now vitiligo after a lengthy debate with the us regulator and involving experts early on they finally agreed to do a bigger phase 3 and cuv doubled the trial as they learned from previous trials. The chances for approval seem to be at an acceptable level.
Clinuvel doesn't want to gamble and lucky so for us they limit expenses for Parkinson or stroke. Both could eat millions for big trials. But still stay a pie in the sky.
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