Can anyone suggest a time frame for BLA process, viz:
"Prima can look forward with confidence to initiating the regulatory requirements necessary to file a Bliological
License Application (BLA) of its flagship cancer treatment product."
The BLA would seem to be a way of funding the stage 2 trials; perhaps users will form the basis of the trials; ie data obtained will be used in the trial.
Does anyone know? Would be nice to get a bit more info. from the company.
Anyway a significant ann. but not quite enough yet. I was actually anticipating approval this month.
positive us fda preind meeting, page-2
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