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HappyLibrarian

04/13/23 12:17 PM

#585016 RE: flipper44 #585011

Which begs the question. Why? How can the contractors possibly be this far behind when data lock was years ago, topline was about a year ago, and even MIA has been approved?



It’s probably Ken Griffith’s fault, or maybe Adam Feuerstein’s fault.
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exwannabe

04/13/23 12:25 PM

#585020 RE: flipper44 #585011

Which begs the question. Why? How can the contractors possibly be this far behind when data lock was years ago, topline was about a year ago, and even MIA has been approved?


Yes, hard to believe the MAA would not be complete 2-1/2 years after datalock.
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CrashOverride

04/13/23 12:35 PM

#585022 RE: flipper44 #585011

Have contractors submitted regulatory applications for personalized autologous dendritic cell based cancer vaccine before?

No!

Nothing's running behind schedule.

Your expectations are wrong.
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hoffmann6383

04/13/23 12:59 PM

#585035 RE: flipper44 #585011

novel dendritic cell vaccine. We are comparing it to things that aren't this complicated. This is a personalized approach for each patient based off of each individual tumor. I'd imagine it takes longer than we typically see for most drug approvals. I'm not freaking out on timelines. NWBO seems to methodically check off the boxes, albeit a bit slower than myself and maybe others want to see.
Bullish
Bullish