RE:BLA submission is this quarter, and like last timeChecks finished Sept 2019, six months running batches for FDA takes us to Feb 2020.
Mar- July, thats five additional months to complete the paper work and submit to FDA. Something has happened, it doesnt take this long to fill out some forms.
Formality is BS
realstocky wrote: it's priority review...will take only 6 months, FDA already reviewed riplazym... it's a formality for the green light, FDA said all good last time, only asked for aditional checked points, all set.