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That was great news put out by Ivanhoe yesterday. I don't see the news on their website though. Here is the full PR -
Ivanhoe Mines Announces Drilling Results From Kakula Discovery- Drills 8.75 Metres of 9.84% Copper and 18.78 Metres of 5.32% Copper
"The consistent frequency of thick intersections of exceptionally-high-grade copper mineralization from both infill and step-out drill holes enhances our absolute confidence that Kakula is a game-changing discovery for the Kamoa Project," Mr. Friedland said.
Earlier metallurgical testwork indicated that the Kamoa concentrates contain extremely low arsenic levels, by world standards: approximately 0.02%. Given this critical, competitive marketing advantage, Kamoa's concentrates are expected to attract a significant premium from copper-concentrate traders for use in blending with concentrates from other mines. The Kamoa concentrates will help to enable high-arsenic concentrates from mines in Chile and elsewhere to meet the limit of 0.5% arsenic imposed by Chinese smelters to meet China's new environmental restrictions.
http://www.juniorminingnetwork.com/junior-miner-news/press-releases/397-tsx/ivn/23884-ivanhoe-mines-announces-drilling-results-from-the-kakula-discovery-drills-8-75-metres-of-9-84-copper-and-18-78-metres-of-5-32-copper.html
Fidelity is only charging me my standard $5.95 commission for buying IVPAF, no fees.
Nonsense should always be refuted with facts.
From 10-K -
ii) On December 22, 2015, the Company received a subpoena from the Securities and Exchange Commission (SEC) which indicates that the agency is conducting a formal investigation. The Company believes the subpoena and investigation relate to the recent unusual activity in the market for the Company’s shares. The Company is fully cooperating with the SEC in this investigation and is unable to predict when this matter will be resolved or what further action, if any, the SEC may take in connection with it.
The 10-K statement isn't even remotely similar to what you quoted -
I simply quoted the Company. Ask them to define what you don't understand.
As for dosing -
This proof-of-concept study of 32 patients with mild-to-moderate Alzheimer’s disease (AD) demonstrated a favorable safety and tolerability/risk profile for ANAVEX 2-73, which activates the stressreducing and survival protein, the Sigma-1 receptor. Presented here is preliminary exploratory efficacy data through 31 weeks (26-week PART B including 5-week PART A) from the randomized (into different treatment regimes) open-label study with ANAVEX 2-73 oral daily dosing ranging from 10mg to 50mg (not optimized in PART B). Further analysis will be performed.
17-week data (12-week PART B including 5-week PART A) as well as 31-week data (26-week PART B including 5-week PART A) of all available patients demonstrate that ANAVEX 2-73 preserves average MMSE and ADCS-ADL (PART B) scores across the entire patient group.
Despite the relatively small sample size of this proof-of-concept, randomized, open-label study with oral daily doses (not optimized) of ANAVEX 2-73 ranging from 10mg to 50mg, data seems to indicate a converging and consistent response for all measurements (MMSE, ADCS-ADL, Cogstate, EEG/ERP) currently throughout 31 weeks (7 months) of ANAVEX 2-73 treatment. Patient retention rate at week 31 is 84%.
Overall, efficacy results demonstrate what appears to be a converging and consistent response for all quantitative endpoints through 31 weeks, including cognitive and functional measures: Mini Mental State Examination (MMSE), Alzheimer’s Disease Co-operative Study – Activities of Daily Living (ADCS-ADL), Cogstate and electroencephalographic activity and event-related potentials (EEG/ERP).
In a disease state where progression is invariable over time, a sustained or stable MMSE and ADCS-ADL score is considered a positive outcome.
Keep in mind that the results are without optimal dosing.
Why I believe that the 2a trial is benefitting a high % of patients -
7/22/15 - ANAVEX 2-73 showed in 83 percent (10/12) of patients positive cognitive effects during PART A of the study, which consists of a 36-day on-off-on not-yet-optimized dosing regimen to assess bioavailability.
11/9/2015 - In a preliminary interim readout of PART B data, ANAVEX 2-73 improved ADCS-ADL score, a functional measurement, over a period of 12 weeks by +3.21 over baseline, with 11 out of 14 (78.6%) patients improving.
Safety is so important. A terrible safety profile is one of the reasons doctors are hesitant to prescribe donepezil. Another thing doctors don't like about donepezil is it's low chance of being effective in patients.
Everything I have read gives donepezil less than a 50% chance of helping patients. I've read as low as a 33% chance.
27 out of 32 (84%) of patients in the AVXL trial are still being dosed after 31 weeks. It makes sense to me that all 27 are receiving at least some benefit or else they would have dropped out.
Even if AVXL's trial is helping 70% of patients, it may still have a positive effect on twice as many patients as donepezil while sporting an excellent safety profile.
Which one would doctors prescribe?
No, not for this Anavex Plus application. Anavex tried to include protection for A2-73 in combo with other drugs and that didn't fly. I don't think that Anavex had done preclinical work on those other combos.
As makemydaze pointed out, Anavex's patent attorney and the examiner had a phone conversation on 7/27. On 8/1, Anavex submitted this -
Applicant agrees with the Examiner's Action that Fig. 5 demonstrates the synergy of A2-73 and donepezil.
Applicant believes that this application is in condition for allowance, which is respectfully requested.
Patent application 13/940352 update -
This is the application for Anavex Plus (A2-73 and donepezil combo) and A2-73 combined with other drugs.
As of 8/1, it looks like Anavex has dropped the other combos from the application.
Up until 6/28, the Examiner had argued that donepezil was only additive to A2-73 and described the combo as obviousness. Anavex argued that the combo was synergistic. On 6/28 the examiner seemed to concede that the A2-73/donepezil combo was synergistic.
On 8/1, Anavex filed - Applicant agrees with the Examiner's Action that Fig. 5 demonstrates the synergy of A2-73 and donepezil.
Applicant believes that this application is in condition for allowance, which is respectfully requested.
IMO, it looks good for the patent allowance!
I consider this a big deal because we don't know what arm of the Phase 3 trial will show the best results, or, even if there will be an A2-73 alone arm. In Phase 2a, it is possible that the group being dosed with A2-73 and donepezil has a few duds in it which would have a big impact on the data, with such a small number of patients. We'll see.
I'm guessing that our partner will be Pfizer or Lily. AVXL's (not optimized) results to date should have these companies looking for a piece of the action.
Pfizer halted their AD trial not too long ago and Lily is having trouble with their AD trial.
http://www.fiercebiotech.com/financials/will-eli-lilly-s-11th-hour-regulatory-gambit-salvage-or-sink-its-alzheimer-s-drug?mkt_tok=3RkMMJWWfF9wsRokuKnMd%252B%252FhmjTEU5z17%252BktUaK%252Fg4kz2EFye%252BLIHETpodcMSspjNbrYDBceEJhqyQJxPr3HJdQN18R7RhHnDg%253D%253D&mrkid=%257B%257Blead.Id%257D%257D&utm_medium=nl&utm_source=internal
What bad news are you referring to?
This 2a trial was not designed to show the maximum efficacy of A2-73 alone or A2-73 Plus. Yes, there are still 10mg doses, which are below the established efficacy dose. The Company is compiling the info they need for a successful phase 3. We all need to understand where we are in the trial progression process.
I think it is important to focus on the bolded (by me) statements in yesterday's PR and from the poster -
NEW YORK, NY – July 29, 2016 – Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), confirms the information in the July 27, 2016 press release announcing positive results from the Phase 2a Alzheimer’s trial for ANAVEX 2-73.
Dr. Norman Relkin, MD, PhD, an Alzheimer clinical trialist and an advisor to Anavex, commented: “To interpret the ANAVEX 2-73 results presented at the 2016 AAIC meeting, it is important to keep in mind the stated goals of this first in Alzheimer’s patients study. This was a Phase 2a study, primarily designed to determine which ANAVEX 2-73 dosages are safe to administer to mild to moderate stage Alzheimer’s patients. The study was successful in establishing the maximum tolerated dose and in revealing the range of ANAVEX 2-73 doses that are well-tolerated by Alzheimer patients. It also provided encouraging evidence that previously reported positive trends in certain cognitive and biologic measures persisted over a period of approximately 31 weeks. However, this analysis was based on pooled data from a relatively small number of subjects receiving a variety of doses. It is therefore unlikely that these findings reflect the full potential ANAVEX 2-73 in treating Alzheimer’s disease. It is unreasonable to draw conclusions about any limits to the long-term efficacy of ANAVEX 2-73 based on the interim Phase 2a findings, especially since no statistically significant decline from baseline was reported, which is impressive. Detailed pre-planned analysis of the pharmacodynamic results is in progress, which is one of the key factors of relevance for regulatory agencies and which will also determine the optimal dose for future studies.”
This proof-of-concept study of 32 patients with mild-to-moderate Alzheimer’s disease (AD) demonstrated a favorable safety and tolerability/risk profile for ANAVEX 2-73, which activates the stressreducing and survival protein, the Sigma-1 receptor. Presented here is preliminary exploratory efficacy data through 31 weeks (26-week PART B including 5-week PART A) from the randomized (into different treatment regimes) open-label study with ANAVEX 2-73 oral daily dosing ranging from 10mg to 50mg (not optimized in PART B). Further analysis will be performed.
We were told previously that 14mg was the minimum for efficacy. PART B had dosing as low as 10mg. This would certainly negatively affect the outcome. What happens when all patients are given at least 30mg?
No, he wasn't, and you should know that!
Macfarlane said that Prana's drug may slow progression by 30%. That's all he said about Prana's drug. He was enthused about one patient's response.
If the data continues to be this crappy, then A2-73 will become the new SOC for AD.
Not worthy?
Is Anavex's research based on beta amyloid or tau therapies like the companies mentioned?
The answer is no. A2-73 works upstream on the cause of AD. I would have thought that this was well known.
To lump Anavex in with the companies mentioned would have been an injustice.
Slides 4 & 5 in the Spring Presentation address "Common in All Neurodegenerative Diseases: ER-Mitochondria Axis Disruption … Sigma-1R Restores Association …" and Anavex 2-73's role.
http://www.anavex.com/files/Anavex_Presentation_Spring_2016.pdf
Hard to imagine that share holders will be selling now.
Hard to imagine that there will be more shorting at this level.
Alright, I give up. I want to enjoy today's excellent news -
We don't need clinical trials.
We don't even need preclinical trials.
We'll just say that A2-73 activates the endocannabinoid system.
Happy?
A2-73 alone is only being dosed in 7 patients. Anavex may well decide to proceed into the next trial with what they have the most info on. That is A2-73 and donepezil.
Also, Caufield Hospital posted info on AVXL's next trial. Included in that info was a statement that all potential patients needed to be taking donepezil. A link to this was posted here. I wish the poster would post it again.
IF Anavex proceeds with A2-73 and donepezil, then the Anavex patent application, that, if grahted, would expire in 2033, becomes very important to the Company.
Missling wrote of potential studies, that's all. Nobody knows if A2-73 will interact with the sigma-1 receptor in such a way as to activate the endocannaboid system.
My point is that this is ridiculous -
Potential studies are the keywords. No research has been done linking A2-73 to the bodies endocannabinoid system.
It's the sigma-1 receptor that interacts with the cannabinoid receptor, not A2-73. There has been no research connecting A2-73 to the endocannabinoid system.
I would say that a share price increase from 4.00 to 7.00 over the last month is the opposite of shorts controlling the share price.
It is not surprising to see a share price decline in small bios in the days leading up to data. I don't attribute AVXL's short term decline to shorts.
Nobody has any idea if A2-73 is activating the "endocannaninoid system" or not. To date, there has only been speculation that sigma1 receptors may limit the damage caused by cannabis abuse.
I love this part -
Yes, George. These are all signs of reversal of this horrific disease!!!
36,000,000 shares long and 4,000,000 shares short. Some of the shorted shares may be longs hedging. I wish there were more shorted. Short covering can help fuel a rally.
Did we just get a subtle clue that data is good?
Leading up to AAIC 2015, CEO Missling bought 1,000 shares a number of times. These buys added to my confidence that the first human data would be good.
The just announced option agreement amendment locks in Dr. Missling's future option grants at near today's price. He wouldn't want to lock in the option price now unless he feels the price will be higher in the future.
Only way for a higher share price in the future is through good data and, of course, Dr. Missling knows the data!
OK, great. So we know now that a rising cost to borrow shares does not necessarily mean that shares are being shorted.
Longs may reserve shares as well if they want to protect their position while holding their shares for long term capital gains.
Currently, the cost to borrow AVXL shares is 48.25%. To reserve $50,000 worth would cost $462.67 a week.
No, he'd make it a fixed number of shares. With a fixed dollar amount, the higher the share price goes during the term of the options agreement the fewer options he will receive.
No, short interest is the number of shares shorted.
I subscribed to a trading service at one time. This service shorted parabolic moves. Their advice was to reserve shares to short in advance of an actual short trade in the event that xyz happened. I only made a few long trades that were recommended by the service.
I think the service was on the up and up but never called my broker to check on reserving shares. That is why I said "second hand".
I'll call my broker in the morning to confirm.
This is second hand and I have reason to think it is true -
Exactly. it was odd that the future option grants were tied to a dollar amount instead of a fixed number of shares. The only way that a fixed dollar amount would work in the recipients favor is if the share price declined over time.
Knowing that the poster is new here and probably wouldn't appreciate it any way, I left out what CEO Missling stated was the most important data to date.
That would be robust dose response.
Every data release to date has been without optimized dosing. I'm ready to see full strength.
Bring on the 31 week data!!!
The share price going into AAIC 2015 was less than fifty cents (2.00 split adjusted).