Akantior, el medicamento de SIFI para el tratamiento de queratitis por acantameba, obtendrá la aprobación de la FDA presumiblemente este año. En USA, los pacientes potenciales multiplican x4 a los existentes en la UE. No sé qué hará la cotización con la noticia.
In the USA, SIFI held a Type C meeting with the Food and Drug Administration ("FDA"), according to its regulatory strategy targeting a New Drug Application ("NDA") in the second half of 2025. The outcome of the meeting supports the company's position that its existing data package, both clinical and non-clinical, will be sufficient for the submission of a NDA and the potential approval of AKANTIOR® in the US, currently anticipated in 2026
