TraderTim schreef op 19 augustus 2020 10:20:
Ik weet niet of dit al gedeeld is maar wat ik hieruit opmaak is dat wanneer GLPG & GLD snel handelen we niet opnieuw een jaar hoeven te wachten:
1) Resubmission. Resubmit the application or abbreviated application, addressing all deficiencies identified in the complete response letter.
(i) A resubmission of an application or efficacy supplement that FDA classifies as a Class 1 resubmission constitutes an agreement by the applicant to start a new 2-month review cycle beginning on the date FDA receives the resubmission.
(ii) A resubmission of an application or efficacy supplement that FDA classifies as a Class 2 resubmission constitutes an agreement by the applicant to start a new 6-month review cycle beginning on the date FDA receives the resubmission