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User-840664

04/02/24 11:44 AM

#682781 RE: flipper44 #682779

Over 3 months now and no news of acceptance, rejection, RFI, No RFI.... NOTHING!

Does not pass the smell test, IMO

StonkMaster

04/02/24 12:01 PM

#682787 RE: flipper44 #682779

DCVAX-L MAA TRACKER

104 days from SUBMISSION

104 to 90 days from VALIDATION

Days to DECISION

46 to 60 days for 150 day assessment (no RFI)

106 to 120 days for 210 day assessment (with RFI)

166 to 180 days for 270 day assessment (with RFI)

mike00h

04/02/24 2:26 PM

#682827 RE: flipper44 #682779

Your comments are specious. If we were off-clock we would know. Linda Liau was hired so she could dedicate full time to explain anything they ask.

Safety profile similar to drinking water, DCVax-L embodies the part of the Hippocratic oath where it says 'first, do no harm'.

I think it's approved. They are just deciding when to announce it.