There appears to be a widespread misconception on this board that PK/PD analysis should be a swift process in such a small trial as this one. In fact, PK/PD analysis is a complex and painstakingly slow process even for small trials. You can easily discover this reality just by doing a little research on the web, but to make it easier, just google Creating NONMEM Datasets and click on the first result, which is a paper that succinctly summarizes the "nightmare" timeline that standard PK/PD analysis presents. NONMEM, by the way, is the gold standard software for readying a PK/PD dataset.
Anavex is only collecting PK/PD data for analysis at Weeks 1, 12, and 26, so that helps explain why Week 5 data was able to be presented relatively swiftly, since no PK/PD data collection was undertaken at Week 5.
Not only is it credible, it is well established that PK/PD analysis takes a long time even for smaller trials. A little reading will show that.
Familiarize yourselves with PK/PD. It takes a long time regardless of the number of patients. Just google Creating Nonmem Datasets and click on the first result. Nonmem is the gold standard in PK/PD analysis, and as the abstract states, "It usually takes months to prepare the NONMEM dataset before the Pharmacokineticist feels it is ready for them to use."
PK/PD analysis is not simple or swift, as experience with other small biotechs teaches. That is what we are waiting for.
The hold up is PK/PD data, which takes much longer to analyze. According to an email from IR, the company is waiting to release further efficacy data until PK/PD is complete, "so that there can be no doubt as to the cause-effect relationship." That is, so there will be even less ground to stand on for those claiming the 2-73 efficacy data so far could be based on a placebo effect (of unprecedented scope in any Alzheimer's trial) or, you know, a cup of coffee or something.
The 379% return over the last year is very disappointing, yes. Barely beats the S&P, right?
Also, since you don't like factual positive info (such as the unprecedented Alzheimer's trial data released on Nov 9, which by the way came after the up listing), I'm curious what non-factual positive info you'd like to see. Maybe you want Missling to announce that AF took a dose of 2-73 and turned into a unicorn?
Maybe that would improve on our paltry 379% return over the last year?
Thanks, I will! Glad to see you still posting here, always one of the best.
Considering that a "definitive agreement to acquire" is already in place, it would only be news if the deal somehow fell apart.
You mean besides the Allergan CEO feeling the need to get defensive about 2-73 after spending $3.3B on an inferior semi-clone of 2-73 whose entire company was deemed worth less than 1/10 that amount before the release of the 2-73 data this year? Yeah, I'm sure BP's not interested, not in the slightest.
When data unprecedented in prior Alzheimer's trials comes out, shorts say Oh it must be the mother of all placebo effects, or maybe it's the coffee. They have very strong coffee in Australia, you know.
Sure, people with Alzheimer's who haven't been able to play piano for three years re-learn how to do it all the time. I think it's actually one of the major symptoms of late-stage Alzheimer's. After all, in the past we've seen dozens of Alzheimer's patients regain complex abilities like playing piano and painting and sustain them eight months after treatment, haven't we, despite the fact that in Alzheimer's trials the placebo effect is not seen beyond 12 weeks? Haven't we? I just can't seem to find the citations right now....
Anavex bought the 2-73 basic-composition patent from Vamvakides back in 2007. The patent adxs228 cites is an additional 2-73 patent for a particular application (I believe cancer-related, but I'm going from memory on that).
I disagree that we need the Plus patent. We have the 2-73 patent and that is enough to protect the company's IP. The Plus patent would just be gravy.