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User-840664

04/04/24 12:16 PM

#683184 RE: CrashOverride #683183

LOLOLOLOLOLOLOLOLOLOLOLOL. 🤣
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learningcurve2020

04/04/24 12:25 PM

#683186 RE: CrashOverride #683183

>>Commercial Coverage
PROvideTM-the PROVENGE Commercial Co-Pay Program that provides flexible coverage of up to $10,000 over 3 PROVENGE treatments. Eligibility is determined by Dendreon.
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exwannabe

04/04/24 12:36 PM

#683189 RE: CrashOverride #683183

Under Orbis MHRA can refer our application to all other regulatory authorities (RAs) without need for NWBO to submit separate applications to other RAs.


No, they cannot.

ORBIS requires an FDA submission and the review runs exact;y as it would w/o ORBIS. What ORBIS allows is for other RA,s to partake in the review and/or to use the review results to assist in their decisions.

As far as the rest of your post, running a P3 trial that failed badly between the arms as designed and trying to use post hoc ECAs (with non patient level data and unmatched trials) does not prove effectiveness.
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manibiotech

04/04/24 1:11 PM

#683198 RE: CrashOverride #683183

And then why has not an application not been submitted to FDA or any status update given .
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Poor Man -

04/04/24 3:24 PM

#683226 RE: CrashOverride #683183

Crash, are verticals still in play?