Replies to post #467153 on Anavex Life Sciences Corp (AVXL)

[sab63090]

Thanks for your response, you seem to be very objective and provide good insight!

[Investor2014]

Agree.



Regarding that the PDD OLE was only completed by 20 patients is not just due Covid, but the very long gap between completing the main trial and initiating the OLE. That in itself may have been due to Covid, but the P2b/3 AD trial OLE at least was ready for completers to enroll in.

[Hosai]

From what I understand partly due to the 41 week covid interuption delay only 33 people started on the PDD OLE trial and 20 finished in so around 60% completion.
If say 70% of the 191 dosed completers continued onto OLE then that would mean 134 from this group. If 60% of 122 placebo completers then 73 from this group.
Would mean 207 at start of OLE so if the same 60% odd OLE completion would be around 124 at end of 96 week trial. Not amazing number number but enough to get some more confirmatory data.
60-70% completion would be roughly the expected completion from this type of trial.
What was the change in wording from the 10k?

[12x]

The sponsor is blinded to efficacy data but not dropout numbers from DSMB. So CM knew about the 50mg dropout issue back in 2022 and then decided to pool both cohorts together in the final SPA, and subsequently changed the titration protocol in OLE. Both were wise moves. It also explained why CM floated the idea of using OLE as a confirmatory P3 trial in 2023 since p2b/3 was not able to confirm dose dependency due to titration issues.

However, the question now is why the company no longer prioritizes the OLE (e.g. did not announce the June trial completion, only mentioning the interim report by year-end). The wording (if you compare the May 10Q and Aug 10Q) has changed to "up to 96 weeks" from "additional 96 weeks", indicating dosing patients not staying through 96 weeks again in OLE.

It's still not clear to me whether the FDA guideline changing to one endpoint can be retroactive or only applies to further studies. Otherwise, all the companies with previous trials hitting one endpoint will come back to apply for NDA.

[boi568]

It now looks like 300 of your 313 - 96 percent - enrolled in the OLE.