Replies to post #405468 on Anavex Life Sciences Corp (AVXL)

[bas2020]

Obviously, they had enough combined data to make a claim of success with supporting calculations. They continue to reiterate their claim and haven't retracted their PR or the calculations.
Recall, they said on the 12/5 conference call that the results are better than they first thought.

I'm excited to receive the updated results, especially the 50mg data. Question is if it'll come before the peer-reviewed journal.

[abew4me]

Quote: "That being the case, please explain how Anavex could declared having met all endpoints?

“We know that Anavex didn't get all of the trial results from one of their CROs until the day before the CTAD conference...which made it extremely hard for them to add up everything.”

Seems to me on that basis, it leaves investors and therefore the market suspicions and unsure, further emphasised by now 3 months later having no substantiating update and the original slide decks removed and replaced by an even less substantial 3 slides in the JPM presentation."

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That's a legitimate question...and frankly, I had to wrestle with it myself. Here's what I concluded:

The LPLV for the P2b/3 trial was in June...so everyone assumed that all of the CROs would've submitted their data within 30 - 60 days thereafter. In fact, Doc told us that it is common practice for the CROs to update and double-check their data while the trial was in progress...so there was no reason to believe that one of those CROs was having trouble.

Okay, fast forward to Monday, December 2nd...which was the week that CTAD was to start.

Missling has all of the results from the other CROs...those numbers have been crunched and everything looks great...so there's no reason for him to think that the last CRO is going to have anything different. In fact, Missling probably has his Press Release already written up.

But that last CRO still hasn't submitted his data!

Why? What the heck is the matter with him? Has s/he broken previous promises to release the data?

Missling has to be ticked off by now...so he tells the CRO to release his data immediately! The CRO gathers up all of the data and emails everything to Missling on Wednesday - the day before Anavex is to present their results for the P2b/3 trial.

Missling crunches everything together and presents the data...realizing afterwards that some this data needs to be researched further. And thus he removes all of the slide decks, hires Dr. Kun Jin from the FDA, and decides to create a video that will validate their success in achieving the primary and secondary endpoints.

That's how I see things from start to finish.

I could be wrong of course...this is just my interpretation of how things unfolded.

[Steady_T]

It would appear that you are under a misunderstanding.
As I understand it the CRO does the calculations on the endpoints.

What we were told is that one of the trial sites was very late in delivering its data to the CRO. The CRO then did the calculations as specified in the SAP and delivered the resulting results to Anavex one day before the presentation.

People have been using the term CRO, which is the company that recruited and coordinated all the sites for the trial, in place of the term trial site. This has lead to a common misunderstanding about what happened.
The CRO does the calculations on the end points. Once the full data set is provided to Anavex then the company can do the additional analysis with KEM etc.

If this is not correct someone please explain what the correct process is.