The info I provided is the info I provided. End of discussion
When is Consultation Considered Complete? For a standard Marketing Authorization Application (MAA), consultation is usually complete once: The assessment phase reaches 80-90% and all RFIs have been resolved. Any required Good Manufacturing Practice (GMP) inspections have been completed. The agency is satisfied with the data and no further input from external parties is needed. The final decision-making process (approval or rejection) is in motion.
Every promise broken are just lies spoken. None of the predicted timelines have come true. No 'FALL', no FDA, no court win, no approval, just the never ending GRIFT OF SH from THE WORLDS WORST INEPT MUTE CEO AND NONWORKING OVERPAID NONMANAGEMENT.