My two cents on the silence and expectations.
Below are/were the expectations for the second half of this year:
1 Top-line data AVATAR
1A Initiation of potentially pivotal Phase 2/3 Fragile X trial
1B Initiation of potentially pivotal Phase 2/3 for unnamed rare disease
2 Initiation of ANAVEX®2-73 imaging-focused Parkinson’s disease clinical trial – expected 2021
3 Top-line data Phase 1 ANAVEX®3-71 clinical trial
I grouped the top three items together, with two under Avatar, as I think they are subordinate to Avatar, as I will discuss.
By far the most important is Avatar top line data. Dr.M has already confirmed that they are talking with regulatory agencies, FDA implied. How can the FragileX trial and UNnamed rare disease trial be defined as PIVOTAL without any P1 or P2? They have been on the presentations for a while, so what is the holdup in getting them going? It appears that these two major trials are dependent on Avatar TLD. Only with Avatar approval or very good Avatar data for the FDA, would the FDA allow these to be defined as 'Pivotal'. So these two trials are waiting for Avatar TLD!
It is common for companies, when something big is in the works, to have a self imposed 'quiet period'. This may be what we are experiencing. Possibly related to why Dr.M skipped over the Avatar slide, in a recent presentation. So when Avatar news hits, we may hear about the 1a and 1b trials mentioned above.
The Parkinsons trials should be a big deal. I am a bit disappointed that they have not started yet. No idea what the hold up is with them.
I expect (#3) the A3-71 TLD, to be a nothing burger. It was a SAFETY trial on HEALTHY people. Imagine how long it has been since A2-73 was in that same situation, and enthusiasm for the timeline should be dampened. Now the follow on trials....!
All IMHO etc.
