Agree, if data comes in as expected(excellent) the trades will be dramatic and positive.
The next PR is critical for lots of reasons. We want evidence of continued efficacy and possibly patient recovery, although that might be a huge variable. We look forward to information on how pt's brains/CNS respond to treatment. IMO if there is evidence of recovery the FDA will be supportive of an accelerated program.
The change in Mini Mental State Examination score (MMSE-Δ) (MMSE difference recorded for every single study subject at the beginning and the end of the five week period) from baseline to 5 weeks as a function of ANAVEX 2-73 dose was examined using linear regression analysis. Among 32 patients treated with doses of ANAVEX 2-73 ranging from 3mg to 50mg/day, the MMSE-Δ data showed a positive slope with confidence intervals not including the zero-value, consistent with a dose dependent improvement in MMSE scores over 5 weeks. The effect was unidirectional and also positive on another pharmacodynamic readout, the ERP-Δ P300 amplitude.
The dose-response results were robust to statistical resampling (bootstrap analysis x 10,000 resamples). Analysis of variance and post hoc tests as well as Bayesian hierarchal analysis further confirmed that the higher doses achieved a statistical significant improvement in the MMSE-Δ score over 5 weeks compared to the lower doses. Based on these findings, it was estimated that an oral dose of 30 mg ANAVEX 2-73 had approximately 80% probability of achieving a +2 points or higher improvement in MMSE score over 5 weeks of treatment. Doses in this range have thus far been well tolerated by the study’s subjects, with no adverse events reported above grade one.
“While we remain cautious about interpreting the results of an interim analysis, evidence of ANAVEX 2-73’s positive dose response at 5 weeks on the MMSE is a welcome signal”, said Dr. Norman Relkin, MD, PhD, an Alzheimer clinical trialist and an advisor to Anavex. “Evidence of a dose-response relationship is one of the factors taken into account by regulatory agencies when ultimately considering medications for approval.”
Good observation. There are other interests at work as well. BP with MASSIVE $$$ will work to optimize their stakes here(Roche, GSK, Phizer..etc) have poured billions into AD treatments and got zero to show. They cannot afford to let this tiny AVXL steal the wonders of CNS fame/glory and $$$$. It would seem obvious but there really is no other explanation for what has NOT happened. If A2-73 works as an effective AD treatment do not expect the obvious b/c of all the other factors. The FDA holds to hand, if they call BTD then game over .AVXL goes out of sight.
"Active Wall St. announces the list of stocks for today’s coverage. Pre-market the Active Wall St. team provides the latest corporate, market and technical events impacting selected stocks on the Healthcare sector. Companies recently under review include Shire, Novartis, Anavex Life Sciences, and Impax Laboratories. See our complete notes on Shire at: http://www.activewallst.com/registration-3/?symbol=SHPG."...found on Yahoo cover
At the closing bell on Wednesday, shares in New York-based clinical stage biopharmaceutical company, Anavex Life Sciences Corp., saw a decline of 6.82%, ending the day at $7.10. The stock recorded a trading volume of 1.18 million shares, which was above its three months average volume of 779,730 shares. The Company’s shares have surged 75.31% in the last one month, 26.56% over the previous three months, and 27.47% since the start of this year. The stock is trading 47.14% above its 50-day moving average and 32.85% above its 200-day moving average. Moreover, shares of Anavex Life Sciences, which engages in the development of drug candidates for the treatment of Alzheimer’s disease, other central nervous system diseases, pain, and various cancers, have an RSI of 71.82.
On June 22nd, 2016, Anavex Life Sciences Corp. announced that the FDA has granted orphan drug status to its lead candidate ANAVEX 2-73 for the treatment of patients suffering from infantile spasms. This status will allow ANAVEX 2-73 to enjoy seven years of market exclusivity in the U.S. upon approval. Moreover, Anavex Life Sciences will be eligible to receive certain development and commercial incentives including prioritized consultation with the FDA on clinical studies as well as exemptions from or reductions in regulatory fees. Register for free and access the latest notes on AVXL at: http://www.activewallst.com/registration-3/?symbol=AVXL.
To reiterate what another poster has said. AAIC has not yet declared ANY podium/speaker-late breaking presentations for the 2016 session. When they do A 2-73 may be a selected topic, just like 2015 at this time.
shrin...I suggest you go to the AAIC conf center and read the definitions-guidelines again. Focus on the part about results warrant....that is TBD at this point since NO SUCH AAIC 2016 has been done....for ANY of the POSTER/OTHER presenters...AVXL may be excluded from podium at some point, but to this point that is not determined/published.
I see you took the bait....just hang on...this ain't our first rodeo
"Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease."...this will be interesting to follow up on...see ya on 7/24.
If you are into shorting then go for it. But first, look around.
AVXL has not even done a PR on showing up at AAIC and yet we know they have invested and will do 2 posters. Last year they had late breaking podium which blew the doors off the place on only small trials history. We got slimed and learned. The PR for that came about about this time 2015. Considering what we have been through over the past year and other (Rett, MJF, anxiety disorder, anecdotes, FDA guidance, a couple of ODD and on-going A2-73)some of us expect another A 2-73 PR of consequence any day now. Many others here w/skill to emphasize or summarize what they expect to happen. We can taste it, it is huge and it's all good. So, have a ball with the negative games. We think the science will be there and we are going to party our brains out when this is over.