Courtesy of DDD on YMB

[biopearl123]

“ This ILAP seems like a much bigger deal than I thought. It looks like Geron has enough data to seek approval. Look at this:
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Criteria 3: the medicinal product has the potential to offer benefits to patients
You must provide a summary of how patients are likely to benefit from the product or indication coming to market, including proposed improved efficacy or safety, contribution to patient care or quality of life, as compared to alternative therapeutic options. This should be based on evidence from the applicant with the product.

The claims can be supported either by data from valid non-clinical models of the condition or if justified extrapolated from another relevant model.

Depending on the stage of development of the product any available clinical data in a relevant population of patients can be provided. Applicants are strongly encouraged to include the views from patients or patient organisations around the benefits of a product in their evidence, if available.