June 5th is not a final date for priority reviewLook at what Francois21 had just told us on the french bullboard :
Le fameux 5 juin n'est pas la date prvue d'approbation du plasminogne.
Les gens spculent l'effet que lorsque une "priority review" est demand, la FDA rpond normalement en 60 jours. Comme PLI avait annonc la soumission finale du BLA le 5 avril, des gens anticipent une rponse de la FDA pour le 5 juin.
Si la FDA accepte la revue prioritaire, normalement l'approbation peut tre donn dans un dlai de 6 mois, plutt que dans le dlai moyen de 10 mois.
Si on se fie aux lignes directrices de la FDA, les chances sont bonnes:
A Priority Review designation will direct overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.
Significant improvement may be demonstrated by the following examples:
•evidence of increased effectiveness in treatment, prevention, or diagnosis of condition;
•elimination or substantial reduction of a treatment-limiting drug reaction;
•documented enhancement of patient compliance that is expected to lead to an improvement in serious outcomes; or
•evidence of safety and effectiveness in a new subpopulation
From my understanding, there is no limit of time to answer for a priority review. So it's possible that the FDA takes another month before giving the approval for a priority review. So we have to wait and see..
GLTA