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Xena, with Rett or PD successful readout, proving 2-73 S1R theories, expect AZ enrollment rate to increase dramatically!
Re: enrollment question, and news going forward.
When previous enrollment numbers were given, predictions were made that 100% enrollment for rett and PD would be near end of July. ( and that was optimistic given that most enthusiastic enrollees sign up early and there is probably a rate fall off.) CM confirms the prediction, by saying "almost there" and "completed very soon".
Lots of fireworks for next 6 months. I expect first full enrollment announcement coming within weeks, and another soon after that...then we are on the clock. The months without news are over!
Hey jimmy, it sounds like this cohort had to provide pk samples (say blood samples) much more frequently than the other patients, say every 4 hours for 24 hours straight.
Yeah his words were something like they expect the drug (2-73) triggers the microbiota, maybe affecting the whole body. Sounded like it was their working assumption, but not a certainty.
Attila, yeah my impression as well. The questions were better than previously, but the analysts seemed ill prepared, like they could not find their questions, and had never been on a conference call before.
Mauismart, amazing the shelf was not questioned by any of the analysts! That is the sort of thing they should be all over! Unreal. This MB was all over it though. Unfortunately CM did not mention it either today.
Fyi the link did not work, call has not begun msg...nice. The phone call in number worked.
Yes very true!
Lol. Literary license...
BLARCAMESINE named after famous mall cop.
Paul Blarc, come on you were thinking the same thing.
Doc328, I see all the science and studies indicating we got this. The only science issue I see is that mouse efficacy only translate to human efficacy about 15% of the time. Do you agree?
Xena, yes they sewed descriptions of the p2 and results, into the recruiting language of the p3 recruitment. Totally separate and NEW 450 people being recruited. Interesting language, as you note. They seem to be very liberal in discussing the results of a2-73. Maybe different legal or societal norms, or nonprofit org has wide latitude in verbage. Lol or maybe we are just used to Anavex super conservative language.
Hey jonjones. Good questions. First, there are many forms of partnerships, based on legal documents to informal agreements based on a handshake. Typically, your proposal that a varying payment, is based on a particular IF/outcome, has a payment arranged to occur AFTER the IF (you propose) NOT BEFORE.
Also, payments are frequently used when the two partners do not contribute equally...the lesser contributor then kicks in cash to make the deal equal/same for both sides.
I am not sure what partnership is NEEDED. If we get AZ or PD approval, CM wants a sales partner and maybe production partner. I fully agree with him, as if approval happens, we will have the most sought after company on earth. The sales partner should get a commission or percentage of sales probably for an exclusive region. Simple and efficient. As far as production, the molecule is small and readily made by many factories. Many will want that business from us...simple and efficient.
Also, do we need cash? We have the shelf for business growth. Again, WITH an approval, if we still need cash, we will have no problem getting a loan from a bank at their LOWEST possible rate. Again "the most sought after company on earth" situation!
If a company REALLY wants to partner with us and have lots of influence, then for the measly sum of 1B$ dollars they could own most of the company. Or for a lot less they could be an influential shareholder...100M$ or less which is peanuts for a large company.
Given the the two figures mentioned above, I dont see a scenario where a company would need to give us cash. Given the shelf and/or approval, I dont see a scenario where Anavex NEEDS a parners cash.
Jonjones, thanks for making me go through the numbers, logic and (some) details of this question - partners with up front cash. Please let me know if I overlooked something. Or if you see a scenario I missed. I think this analysis explains CMs position on partners. Good discussion to have...after all we are the owners!
No. We are a drug company. Precision medicine is a process, not our product. Stay on target (Skywalker)
A2-73 already has ODD for Rett and Infantile spasms in US! Needs trial positive results(leaks will do!), not more ODDs, nor presentations, nor more enrollment news. Should have results in 6 months.
Xena side affects etc good points. Thanks.
Jonjones et al regarding consortium...
These type of consortiums are generally open to anyone that has a legitimate interest and pays the nominal(typically) entrance fee. The purpose of the consortium is to establish new ERP industry accepted testing standards. Consortiums are OPEN so that the standards can get industry acceptance! Companies are more accepting of standards if they are ALLOWED(open) to join the consortium.
Cognision founded the consortium (not Anavex). Cognision wants their headgear/hardware/software approved to be used for all the testing needs down the road. Anavex is just one of several companies (maybe even competitors) working together to define the uses and methods of obtaining ERP data with the Cognision (or equivalent) hardware/software. Note: There could even be Cognision competitors in the consortium. They will all work together. Consortium members do not share any more intellectual property than is needed to develop the standards. So this is not a grand partnership. (Could a partner come out of this arrangement, sure but a partnership could also come from company XYZ because the CFO of XYZ was Dr.M's roommate in college.)
Yes Jon, exactly as you said, this framework can be used to test and validate any drug. The standard could also be used to test for ALZ as part of the diagnosis!
The results, eventually will be, industry standard test procedures per disease (like ALZ), industry accepted ERP disease measurement levels, more accurate measurement of drug responses, measurement driven data, and on and on.
One final opinion here. Because of the above, I think Anavax should soon NOT be sending the CEO to these meetings. Soon they should get down to brass tacks and send an engineer or scientist...which is part of the hiring expansion they will need to begin soon(if drug approval). Part of the shelf????
Regarding the gut bio vs cns cause/effect question (chicken/egg), Investor and tradeherpete have been discussing.
I read the publication several times looking for which was the cause and which was the effect. This would be very important information! I agree the wording is vague, and certainly not clear to me which is the cause.
I think the writers intentionally did not specify this cause/effect because they did not know. Certainly in a science publication, like this, they would love to break that kind of news. But when one does not know the cause, just publish the data. That is what I think we have here.
To their credit they are studying some of the first data available and they do not have all answers and mechanisms understood yet.
Dado, interesting Friday thoughts, just getting around to my Saturday responding...
Seems like Keppra and Lamictal are competition for A2-73, based on your promising results. Particularly Keppra with improved cognition.
Therefore, I dont understand your final statement, "...the possibilities of our drug just keep growing.". Seems like more competition to me? Please advise.
Good luck to you and your patients with their new prescriptions! Sounds like you are on to something good!
Steady, good post, knowing the Russell addition was coming, and shorting the bump makes total sense...Occams razor for the win
Thoughts on recent issues
Some in response to gator...
Gator questions why patients would stay in an extension at 148nweeks, if they had to pay for the drug themselves. We are talking ALZHEIMERS here...losing cognition. How much is cognition worth?
True, drug continuation is provided to patients as a way to motivate patients to enter the trial. But still going at 148 weeks. I wonder if any other AD trials are still going at 148 wks? Anybody know? If no other drug is, then I would say A2-73 is VERY Extraordinary!
Gator notes that N, is not given after 148 weeks. I think the data has dried up as well. Not just N. I think the reason for this data dearth, is that it recent data is being saved for the peer reviewed article. TGD wants max fireworks for that article. He is not going to steal his own thunder early.
Why no article yet? Many high level publications come out quarterly. I am not concerned unless it does not appear by the end of year.
I still maintain TGD was truthful when saying funding is fine. I think he referred to maintaining the current trials. I think the shelf was to fund anticipated growth needed, assuming AD or PD success. Will need to grow quickly, hire many more people, labs, lab space, building for more employees... !! It may be just in case there is success, but TGD might have some feedback...trying not to speculate here.
The stock price may be low, but I agree with Xena, showing it is HFT. Remember all the science and news still support our theories of efficacy!
People complained that the gut data was not complete. True, but it was a very low amount of data, and still it made sense in relation to the latest theories. TGD was right to keep analyzing the data. He would be NEGLIGIENT if he didnt. And there were complaints SMH. We may not know exactly all the mechanisms of why 2-73 works, but we have theories. And the trials, hopefully, will prove efficacy, that will satisfy all.
I think one of the major reasons biomarkers and ERP may be yielding fruit now is because scientists will now have a drug to use them with in testing for patients actually improving!! We sometimes do not see these trees because of the forest. For example consider biogens predicament, they never had patients improving, so they were stuck trying to work with the placque, as that is all they had! Having NO patients improving is like trying to play baseball in the dark. Now with patients improving, lots of new science can be tried.
We got this!
GAB, it is interesting that almost 2/3 of the patients are claimed to be still taking 2-73 after at least 148weeks (extended into 208 weeks!!). Point is this is a large percentage of Alzheimer patients, who generally decline!
Also, the patients are still participating in tests, evaluations, maybe visits to AU neurology hospitals. Point is, it is not easy, but rather a BURDEN for them or their caregiver, to continue to participate. (For a drug that it is not working?)
I think these 2 points are good indirect evidence of efficacy.
Lima I gave him the statement, whether with or without placebo, one could argue there have been no real AD successes- hence failures.
I agree a2-73 appears be the exception, which is what I was trying to convey with my warning to never say never. With next approval for 2-73 for AD, his statement will be unarguably wrong!
N2deep1 correct!
N2deep says:
Any study for AD over 6 months without a placebo is a failed study.
vg_future, thanks for your comment
- Possibility 1: some partner wants to join the party with a stake in the game. Why would Anavex do a shelf offering if all these days you have been using LPC type private placements...interesting. So, this is a great possibility
- Possibility 2: Anavex is close to some big milestone and needs huge influx of money to carry through the next phase phase...small LPC deals aren't enough for this phase.
Here is the GOOD and the BAD.
This shelf offering is consistent with what should be done, and with what Dr.M has said. Here is why.
THE GOOD
1) We have had enough money to fund the current trials and maintain THIS status quo. Consistent with what Dr.M has said. True. But Dr.M must see those days are coming to an end!
2) However, Anavex is about to move to the next stage, and needs more capital. Cant get a loan, no income, so sell stock, that is a major purpose of stock.
We cannot advance as a 20(?) employee company, with one financial person, no accounting dept, Dr.M going to ERP consortium meetings instead of an engineer, and a high school kid doing our website(maybe)
Seriously, we will need an accounts receivable group, a professional IT group, legal team, chemists, engineers, HR, a PR group and so on, just like the big boys. This shelf offering is because Dr.M realizes that in a few months we may be in the big leagues and need to be ready to play.
3) This offering has nothing to do with takeover, or partnership. Consistent with what Dr.M has said. The only partnership that Dr.M has been discussed is for distribution and MAYBE manufacturing. This is exactly the best path.
DISTRIBUTION: We do not have distribution networks, so we will need 'partners' for that. With positive AD results, we will be the most sought after company on earth. We will not need any partner, except as Dr.M has discussed. These arrangements are usually simple, the distributing company gets a percentage of their sales. They will balk at providing a bundle of money to Anavex for the privilege of working with us. We wont need it anyhow.
MANUFACTURING: As Dr.M has done, contracted out manufacturing of current drug 2-73. This is not a partnership, but could develop more.
4) This has nothing to do with buyout. Period.
THE BAD
1) Dilution. Yes this is dilution. But $250M hopefully can get us several steps closer to the $10B(?) company Dr.M has discussed. Then it will seem like a drop in the bucket.
In conclusion, if you believe Dr.M has been frugal, and a good manager, then this should be seen as good news, as he must see good news already, or expects it in the next 6 months.
If you think Dr.M is a liar, then you will see this as lifetime haircuts.
Also, I realize several MB contributors have come to some of these conclusions also. Hopefully, I have added to their contributions, and correlated their comments. I truly believe the MB collective wisdom is better for ALL the commentors, both positive and negative. And Xenas compiled DD is a great example of that.
Not trying to rival Bio here in length
Occam's Razor - Problem solving principle.
When faced with competing answers to a problem, one should select the one which makes the fewest assumptions (generally the simplest)!
Attributed to philosopher William Occam, who used the principle to advantage.
I find that even when I have questions about company strategy, I should consider this principle. Keeps me from overthinking the question, and getting carried away with to many IFs.
Lima, anavex's website gets little attention. They just got around to removing HH from it. Simple as that. How can an employee of one company be advising a competitor. And there is no partership, at least as of today.
Vol.AVXL=1.6M -- BIIB=1.3M ouch!
Must be because of Russell index, Bourbon. Result is huge volume.
Others funds having to match the Russell 3000, did NOT have pre-arranged purchase... Nice!
Opinion stated as fact!
Volume 1.2M huge. Nice to have a close near high of day!
Jager, thanks. Could be Anavex suspected something like this would come about (index add), and decided to use it to raise money. As Xena suggested it was prearranged. Makes sense.
Xena, thanks for comment, prearranged trade. Makes sense.
One of these days someone will want 3,000,000 shares and there wont be pre-arranged....they will have to bid enough to pry the shares from our hands!
Can someone tell me where the 3,125,804 avxl shares came from that were sold just at the close?
I presume these for the for Russell index inclusion, but this is ten times the normal volume, in one trade. Was this pre-arranged? If this was the MM, wow how did they accumulate that many shares? Was this LPC or Cantor?? If yes, why would they sell so low, knowing that index demand would drive price up??
I do not understand this. Why does retail never benefit? Can anybody explain?
Thanks.
Investor, yeah, dunno what the drug is.
Our Rett trial is at UAB, but over 18yr olds.(https://clinicaltrials.gov/ct2/show/NCT03758924?term=NCT03758924&rank=1)
Wow. Nice find india.
UAB is right, but as others said...age is wrong.
Wish this was a2-73. Oh well GREAT for the Rett patient and family. Couldnt be happier for them.
Question to the MB...
Frequently, stock prices begin slowly rising prior to earnings reports as investors expect good news.
Since Avxl has a reasonable chance of 2 readouts by the end of year...
Do you think we will see a slowly rising SP as we approach end of year, as expectations grow? If yes, any idea as to timing?
I have not invested in baby bios before, so wondered if this happens before readouts.
Thanks for comments!
Xena not sure if this is what you are referring to, but here are two I have checked.
Rettsyndrome.org
Girlpower2cure.org
They see to try to build community.
Given how rare the disease is, I suspect the caregivers know other caregivers, and word would get around if efficacy was seen.
Anavex has published washout times of 12 days for A2-73 for the original AD trial extension patients. (See Anavex-ANAVEX2-73-CTAD-Phase-2a-November-2017.pdf) This supports Doc328s assertion that 7 weeks seems like a long time.
Wasnt able to follow the board today, but read the PR and also wondered if the patient(via caregiver) might have been on the placebo (not knowing for sure), and now wants to be sure the real drug is being taken.
Thanks to SteadyT and Doc328 for running down these questions.
I agree the news is nice, but since blinded, cannot call 'efficacy!'.
As LakeshoreLeo said, a vague PR is, oh never mind I forget, but it was apropo!
I think I would be more excited if there was some Facebook post from a mother saying her girl is doing better!
Xena, thanks, the article is a good suumary of the anavex science. Suggest adding it to the Compiled Due Diligence sticky.
Agree, Investor gave an honest answer, no right or wrong answer. Certainly many would say 0%! The value is seeing what various investors give as an AVERAGE or RANGE of success chances.
I have been thinking that it would be interesting to use the MB as a statistical tool something like what has been done with the Success% question. The mb contributors would be like analysts that track a company. Typically, these analysts are then referenced in the media to provide high,low, average SP estimates. We are like these analysts as we know Avxl very well.
One application might be to get mb estimate of how high SP would go in the next month...with application to then buying Call option, etc. Based on mb estimates.
I am proposing taking the Mb inputs to another level, way past just posting of comments.
Comments?