Anavex Life Sciences Corp (AVXL)

[Doc328]

Though material events need to be disclosed rapidly (i.e 4 days), there is no standard definition of a material event. Certainly, any FDA action like a CRL or denial would be considered a material event. Practically everything else is open to interpretation.

In the past, I had been under the impression that clinical trial data topline data would require rapid report but no longer believe so after finding clear-cut examples of long delays between receipt of data and report and discussion a couple months ago with a person who is in private equity.

There are multiple examples of companies clearly having data from trials without disclosure. The best example is that large pharma rarely if ever reports phase 1 data and they may not always report phase 2 data. Would it be legitimate that Big Pharma can play with one set of rules and Baby Bio another? Obviously, P1 results are rarely material to a revenue-producing company but P2 is grayer.

I also know of a couple of P2 studies that were never PR'd. Recall back in 2019 that AVXL and LLY were both doing PDD phase 2 trials (LLY's was fairly large at 300 patients). Despite LLY finishing around July 2019, there was no TLD PR 8-12 weeks later or even 16-20 weeks later like AVXL's. In fact, there was nothing until the data was published in December 2021. I think it is fair to say that a negative study for PDD mattered far less to LLY than it would to AVXL but it's still an example of very delayed disclosure. I don't think different rules for different companies would be legitimate

Is phase 2 ever truly material? A company can have a positive Phase 2 and decide not to do a Phase 3 (i.e. secukinumab and also rituximab in MS). A company can have a negative phase 2 and decide to go ahead with a phase 3 -- maybe they had a trend that was not significance < 0.05, maybe posthoc subgroup analysis showed a glimmer of hope. The P2 does not always predict whether there will be a future NDA and there is no revenue, always material, without the NDA and subsequent approval.

So maybe Missling got TLD by year-end from the CRO and has decided to do more analysis before the disclosure (what I believe) or maybe the CRO has been lying to him about deadlines.

Regardless, the joker on Stocktwits is clueless. There was no Anavex FB post as he said. A quick read of a few other posts from that handle are wrong or fanciful (he has 310,000 shares - quite a bit for a basement dweller)