I think its more important to see what Missling said about PDD. He has a legal obligation to be forthright.
In the prepared statement he read at the beginning (likely reviewed by a lawyer) he said "Finally, Parkinson's disease dementia top line results from the Phase II study are forthcoming and are expected to be announced during this fiscal quarter."
So we have a new word. What does 'forthcoming' mean. He was actually rather clear in this regard. To an analyst question he said "We said this quarter. And also, it will definitely be this quarter. I don't want to go in more specifics. We will report exactly when we have the data.". So we have a firm deadline of September 30, 2020. He seems adamant so maybe he has been told data is analyzed and a report will be with you by next week or end of August.
I think its fair to say that if Missling does not know the results that Clint does not know. In the Q and A Missling said "Right. We don't want to exclude anything. We just really take this as a very objective study to look at what happens in the study when treated with ANAVEX 2-73 versus control. And this is what we really look forward to seeing." and then in follow up said "Right. We just want to see a signal first, and that could be however it is, and that would be then -- certainly, we can move from there by sharing with the regulatory bodies and take it from there since it's a highly unmet need since now almost 80% of all Parkinson's patients develop dementia." When combined with "We will report exactly when we have the data", I take this to mean we have not yet seen the data.
Maybe it comes across different on the taped CC but the transcript statement is less confident than previous CC phrases. This might just be one of those poor communication things we have become accustomed to. Alternatively, the Statistical Plan (he has access to it, we don't) may have a hierarchical reporting -- if Top-line on the entire population is positive, they write report and send to Anavex, if not they do the stats on genetic subsets..if positive they report. If not they evaluate the secondary endpoints and then regardless of results send them to Anavex. He knows, like everyone else with a calendar, that we are now at 12 weeks post LPLV. Could delay, mean the statisticians are doing more pre-planned analysis before releasing to the company? Or maybe they just had one site that took 8 weeks to answer all the DCF queries and the top-line report is being written now
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