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The full presentation isn't even out yet. Calm down people. This same insanity happened with the abstract release. Yes, the data is positive for the primary end-point. Yes, the data is suggestive enough to qualify Phase III clinical studies.
This is very much how I feel. We will see very soon if we are right.
I wouldnt be surprised if they took a MMSE score at week 5. Remember, one of the major criticisms levied against the prelim Part A data was that Anavex was simply correlating P300 amplitude to MMSE change. I'm sure the researchers were curious themselves (given the significant P300 4x amplitude increase vs. donzepil) what the MMSE was at that time. This wasn't a primary endpoint, but still, wouldn't you want to know given the huge potential increase in efficacy?
I don't think you can read much more into the sentence than that. My guess is 5 weeks was simply an additional MMSE added due to the unexpected P300 results.
Who knows if MMSE with 273 was better, "on average" than donzepil, we will see over the weekend. My hunch is yes, although it seems odd to me why it is not mentioned. Thus spawns my theory that perhaps the temporal effects of donzepil on indicators were modified as opposed to the amplitude.
http://www.anavex.com/files/Anavex_Presentation_Fall_2015+.pdf
Take a look at their chart on page 21. 1 month with 273 seems to be close in P300 change % to 6 months on donzepil. This is pure speculation but increased rate of activity is a clear possibility. What would be left to be discovered is whether or not these levels are then sustained for longer than donzepil, thus prompting the sentence: The current results seem to justify a prospective comparison with current standard of care in a larger clinical trial study.
I am more than likely incorrect. We all are trying to make the best out of incomplete information.
The biggest take aways are:
1. The drug was safe. (more important than some might think)
2. The researchers believe the drug 273 has shown enough promise to justify additional trials.
3. The drug 273 showed clinical improvements in several indicators.
These facts alone should prompt increased pps. There is a lot of potential and a lot of risk. But that's what sets these stocks apart from others. GLTA
My best guess is that weekend data will be positive but inconclusive. Anavex will want to run more trials, investors will want more information, and we will be all left cautiously optimistic.
Imagine data which shows faster improvement in cog, mmse etc than donzepil but sustained levels near the maximum expected for donzepil. Many may interpret this as "bad" or "unsatisfactory" but said speculative results may suggest that 273 is acting to prevent the future decline of these indicators (something donzepil does very poorly), more data would be needed.
Alzhiemers is a complicated disease (The Good Doctor has said this over and over again). I have no doubt data will be good and justify higher pps, but the market may not realize it immediately. Don't overestimate the general public's ability to interpret scientific information, we only have to look to climate change, vaccination, and nutrition debates to see evidence of this.
Disclosure, I am VERY long in AVXL and will be holding through data.
All abstracts are released at the beginning of the symposium. This is how the scientific community operates. I am not familiar with Alzheimers but this is common practices among oncology symposiums as well. (How else would you decide which programs to attend?)
http://www.ctad-alzheimer.com/registration/book-your-accommodation
Agreed. Average in this case = mean. That is how data is graphed, any other interpretation is convoluted. Majority - > significant majority however may be telling. We will see.
My opinion is simple profit taking combined with being overbought. It makes no difference in the long run if the expected positive data is presented.
I can't believe any honest individual is interpreting "average" in this context to mean mediocre. It could mean several things and be interpreted negatively (maybe only a few patients showed MAJOR gains) but to read it as mediocre seems dishonest.
Are you sure this is correct?:
There is NO ALZ treatment which improves the MMSE score of ALZ patients. The best that can be hoped for is some slow down in the loss of cognitive abilities for those with ALZ.
My understanding is there are drugs (donzepil) which can improve MMSE. Please correct me if I am wrong.
Also, the sentence was incorrect in context. Read:
"The primary outcome of the study is safety, and ANAVEX 2-73
was well tolerated. In the secondary outcome endpoints preliminary
analysis of data from subjects to date shows an average improvement
of the MMSE score at week 12 in PART B (week 17 from baseline). "
They go from talking about Part A to Part B and confuse the two in the first abstract. A decision was made to stick to the context of Part A. The old sentence made it seem like the secondary outcome endpoints of Part A were being justified by results of the Part B study. See how that would be confusing or even incorrect?
"They are presenting Full Part A data at the Conf and only prelim Part B. The abstract including info re: Part B would not be proper, thus the change."
This would also be consistent with a presentation of Full Phase 2A data. The previous abstract spoke to the ongoing Phase 2B trial of which there is only preliminary data. Perhaps someone thought it would be improper to speak to Phase 2B data in the abstract of the completed clinical trial (I tend to agree). We will see this weekend.
It could ALSO mean that the trend was increasing over time as suggested by the previous abstract version. We will see this weekend.
Source: http://money.stackexchange.com/questions/22451/what-is-the-short-sale-circuit-breaker-rule
Summary: The phrase "short sale circuit breaker" rule normally refers to the SEC's recent adoption of a new version of the uptick rule. The new uptick rule triggers a ban on short selling when the stock drops a certain amount. The SEC defines the process like this:
The "circuit breaker" is triggered for a security any day the price declines by 10% or more from the prior day's closing price
The alternative uptick rule, which permits short selling only "if the price of the security is above the current national best bid."1 The rule applies "to short sale orders in that security for the remainder of the day as well as the following day."
Example: If a stock closed at $100/share on Monday, the "circuit breaker" would be triggered if the stock traded at or below $90/share during Tuesday's session. Short-selling would be disallowed until the start of trading on Thursday unless the short-sell price is above the national best bid, i.e. on an uptick.
Purpose: The stated purpose of this rule is promote market stability and preserve investor confidence by restricting potentially abusive short selling from driving prices farther downward during periods of increased volatility and downward price pressure. Whether or not such rules succeed is a matter of some debate, and the SEC removed similar uptick rules in 2006 because "they modestly reduce liquidity and do not appear necessary to prevent manipulation."
It sounds to me like the Good Doctor/Others Involved got a bit too excited about the positive efficacy data and were told to reign it in as the primary end-point at this stage is safety. We will find out over the weekend.
This makes sense then why they would have released a revised abstract and removed the Phase 2B information. (ie. Significant majority showed improvement). Releasing such information publicly and officially would have breached policy.
This actually makes sense, perhaps the decision was made (seeing as Phase 2a_b is not yet complete), to only include the complete data as discussed in the revised abstract. Only time will tell.
I believe fair pre-conference price to be at least $16. ($4 pre-split). I will be holding through PR, as all signs point to good news. Those planning on buying in before PR, keep in mind how undervalued AVXL was and is pre-NASDAQ hype.
Any way we can listen in on this call?
Im proud to say I helped contribute to the uptick. Bought at .405 when everyone was at a standstill.
Did some research on AVXL tonight... this company is REALLY exciting... Wow... I don't own any stock in it but I really hope the trial goes well!