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manibiotech

09/29/25 6:22 PM

#790386 RE: underpar71 #790385

" questions related to crossover, change in endpoints, ECA"
I would assume those questions should/would have been asked long time ago - as in early last year, not months to a year doing inspections . 
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Investor082

09/29/25 6:46 PM

#790389 RE: underpar71 #790385

They already took more than 3 years from data lock to submit the application. So if they didn’t have the trial design, data, and everything properly documented from each site, then I am not sure what they did during those 3 years.
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AllSheWrote

09/29/25 7:12 PM

#790390 RE: underpar71 #790385

You would have to be clinically insane to not see there are major issues with the data and that's why it hasn't been approved after almost two years.