Potstock88 I agree with you. Adding to your post, I found a nice article about the relation of open label extension studies in rare disease here:
https://blog.covance.com/2016/03/the-evolution-of-open-label-extensions-and-rare-disease-studies/
worth noting is the following:
However, incorporating a patient-focused approach takes more than simply running an open-label extension. Sponsors must consider:
- Early engagement with the patient community
- Fortification of natural history data
- Acceleration of preclinical safety studies
- Early vetting with regulatory agencies
- Robust informed consent development with external input
- Development of a solid long-term plan for data interpretation to provide the reassurance needed to acquire adequate financial support.
The bullet point in bold is I think a very interesting one, ACADIA uses the data from this study to argue with the agency in regards to the pricing of the product. If ACADIA is in the position to provide solid long term data about Trofinetide and its benefits for the patient, it may well have a positive effect on the price tag of the drug.
IMHO, do your own research
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Potstock88 I agree with you. Adding to your post, I found a nice...
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