Beets schreef op 11 juli 2012 23:17:
[...]
Het zou iets sneller kunnen.
Once the application is submitted, the FDA has 60 days to conduct a preliminary review which will assess whether the NDA is "sufficiently complete to permit a substantive review". If the NDA is found to be insufficiently complete (and reasons for this can vary from a simple administrative mistake in the application to a requirement to reconduct much of the testing), then the FDA rejects the application with the issue of a Refuse to File letter which is sent to the applicant explaining where the application has failed to meet requirements.
Assuming that everything is found to be acceptable, the FDA will decide if the NDA will get a standard or accelerated review and communicate the acceptance of the application and their review choice in another communication known as the 74-day letter. A standard review implies an FDA decision within about 10 months while a priority review should complete within 6 months.
Dit is de procedure voor een NDA.
Aannemende dat voor een BLA hetzelfde geldt, kunnen we wat data doornemen.
Stel einde trial 4 okt.
Half Dec.na analysis of the results, indiening BLA.
( 60 days to conduct a preliminary review ) dus half Feb 2013 ( if found to be acceptable ) einde BLA.
Daarna 10 of 6 maanden. Dus half Dec of half Aug 2013 de FDA decision. ( minus het aantal dagen van mogelijk eerder behalen van het boven omschreven. )
groet Camobs