ACAD
Va a estar jodida. Ya nos venden que la FDA está abierta a negociación de nuevos análisis y patatim y patatam, pero la negrita lo deja claro, que no se nos olvide. La opción de final de año puede ser interesante jugarla a corto si subiera algo preevento.
the FDA reaffirmed their stated position in the CRL that pimavanserin should be studied by individual subgroups of dementia and advised us that the best path forward to conduct an additional clinical study in each of the subgroups for which we seek approval. In the meeting, we highlighted the consistent and clinically meaningful efficacy observed in the DRP population overall, as well as across individual dementia subgroups [Technical Issues] Alzheimer's disease, dementia with Lewy bodies, Parkinson's disease dementia and patients with mixed pathologies.
As a result of these discussions, the FDA indicated that they are open to discuss additional analyses from the HARMONY study and the -019 study that may support a potential resubmission without conducting an additional study. We're planning to discuss analyses with the FDA at a meeting later this year. In parallel with preparations for this meeting, we will also prepare for all potential outcomes that may come from this discussion.
«Después de nada, o después de todo/ supe que todo no era más que nada.»