Replies to post #496166 on Anavex Life Sciences Corp (AVXL)

[Bourbon_on_my_cornflakes]

the OLE is corroborating information
the actual trial will determine the outcome, not the OLE
so size of OLE doesnt matter much
Trial data appear to show significant benefits for many
with no significant side effects
and no better alternative therapies.
Approval is highly likely.

[sab63090]

Investor

Thanks for that clarification!

I certainly believe that COVID had an impact on the original trial, but that only 20% of the 462 who participated in the original trial decided to enter into the OLE (93) is an eye opener and not that great!

For some reason I had thought that the overall result was reported as excellent.

[BakedLangostino]

Here's the thing: the "E" in OLE stands for extension. It's extra info that helps track long-term safety and efficacy -- for instance, does it cause cancer or does it lose effectiveness after a few years if people build up a tolerance? The dropouts that happened after the trial ended will provide useful information but that's not going to be the priority for the EMA review team. They're going to look at the data results while the trial was ongoing first and foremost, and that data is pretty solid. The OLE data from those who didn't drop out is also very solid. They'll add up those two factors to make a decision.

This could very well be approved under the guise of 'it's safe, appears to work well for a lot of people, but it's up to you if you can handle the dizziness."

[georgejjl]

“… No matter the reasons; Covid and others - the OLE n completers was about 20% of the main trial completer n or about 93.

That is a hefty OLE dropout rate..,,”

The fact that the OLE recruitment occurred during the worldwide pandemic is a perfectly understandable able reason for the ow recruitment in the OLE study,