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bas2020

08/22/23 12:05 PM

#428153 RE: Joseph_K #428152

Well, this might put a hole in the FUD narrative... to perhaps have a "peek" this year.

With LPLV for 96 weeks at July 31, 2024, then the "readout ... done at 48 weeks" should be done soon.


Just might bolster the approval odds.

(Or perhaps the "48-wk readout" expectation now gets retracted.)
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Investor2014

08/22/23 12:35 PM

#428158 RE: Joseph_K #428152

Usually also for an OLE trial the CRO will package up data after LPLV.

But as it is an OLE in principle a 48 weeks LPLV could be snapshot and analysed along with cognitive and functional endpoints as well as biomarkers.
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Hoskuld

08/22/23 12:39 PM

#428159 RE: Joseph_K #428152

There is no readout done at 48 weeks. Pure fiction.

The full OLE results will be released when the trial is complete and Anavex has the full data set - probably late next Fall 2024.

Anavex already has P3 OLE data for ~350 patients who already completed the OLE. Data for these patients can be submitted at any time to the FDA to supplement the P3 trial data.