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Someone asked me the other day why I’m so sure this is going to be a successful trial given the current knowledge we possess of A2-73. I can Compartmentalize this question in to many categories of check the box...
1.) The SR-1 receptor is virtually unchanged over thousands of years of evolution across all species of mammals and present in all mammals which tells you not only is it important but there is virtually no variation .i.e. what works in a mouse will work in a human; plain and simple do to the fact we know it crossed the blood brain barrier in both patient models the same results are virtually guaranteed...although possible to be different, highly unlikely....also the trial approach and theory is not a repeat of previous failures.
2.) Non existent academic rebuttal papers disproving or attempting to disprove/discredit the science.
3.) Non existent competition/SOC, along with major players deciding not to compete at all.
4.) Australian government, Micheal J. Fox, Rhett’s foundation which are legitimate players backing this small company...this doesn’t happen randomly very often....governments don’t listen to small businesses unless it’s legit or we have an inside track.
5.) Caregivers requesting extension of trial not the other way around.
6.) Whether you want to believe it or not we have a CEO who has already taken a small company and made it worth billions in the past, so he knows what he is doing for long term success.
7.) The BOD is made up of well respected scientists in their field.
8.) we have no debt, we are positioned to finish our trials for the next two years and have access to an ATM if need be moving forward.
9.) Governments around the world are going to be desperate for an answer to a problem that could collapse health care so they will be highly motivated to fast track if we have the goods.
10.) I’m risking less than the price of a hamburger per share.
Put this many positives together in alignment says only one thing...success is far more likely than failure.
I honestly don’t see how anyone looking at this objectively can read so many positives as a negative...you might be conservative and waiting for final confirmation with trial results and that is fine, but to try to spread FUD based on fairy land thoughts is ludicrous....and only would happen if your short, working for those who don’t want AVXL to succeed (no moral code type individuals) or you really have no excitement in your life and maybe need to grab a beer and try living a little.
Have a good one amigos, and stay Frosty
They set up the trials to run brilliantly....the shorter 14 week Parkinson’s trial will also be evaluating cognitive effects of Alzheimer’s patients as well...I.e. they are treating and examining the effects of treatment in Alzheimer’s patients....basically the team is setting themselves up for a review of Parkinson’s but at the same time leaving the door for fast track status open; or early conditional approval based on the Parkinson’s trial for Alzheimer’s while the official Alzheimer’s trial is conducted. It will be exciting to see how both diseases respond to the currently developed dosing ranges; and don’t be surprised when early conditional approval of Alzheimer’s is given when all of a sudden these patients start dramatically responding...
Go AVXL
You can hear what you want to hear but if your really listening objectively it is obvious this company is heading in the right direction based on both the message and tone of voice with which it was delivered...clearly they are mimicking if you will what is going on in oncology drugs...using AI, Genomic understanding and unbiased data driven science to lead them to a conclusion....I.e. effectively minimizing human error and human tendency towards being self serving (corrupt) in their goals to run a clean study...Anavex is breaking away from the old way of pushing forward with hypothesis driven science and pioneering a new way of thinking; very much like you are seeing in many other technologies currently...Anavex has found the new way which is much more cost effective, and will end up being faster once the path has been blazed for other companies to follow....you may be comfortable using a typewriter but I think we can all agree the computer is superior in many ways....innnovation moves science, not inside the box thinking which seems to represent the voices of those who are constantly negative about this company....you must have an agenda if you don’t like a company in this space who is debt free, is able to run the next 2 years financially with ease and is looking at starting 3 trials this year....so it’s a little slow getting there,....so what... what do you expect from a company who is blazing the trail for others to follow...even a blind man would recognize it is easier to walk on a paved road than through Thorn bushes grown by BP in front of the path ahead....I’m not saying don’t ask question and keep the company honest, but be realistic in your expectations given the size of the company, the scope of the operation being ran and the fierceness of the enemy we are up against....if your trading that’s one thing but if your a long looking at the facts it is pretty obvious which side to be on.
Have a good one
I have never read one article that has discredited or shown anything but positive results with the study of A273...there have been people who have talked a lot about the company, CEO, BOD, the trial size and our abilities to potentially get expensive trials done with our cash position....but I have never read any article discrediting the science by any respected scientist...in this day in age that speaks volumes in my opinion...
Woot woot
Andy
Hey Fireman, sorry to hear about your mom...cold laser therapy is very cost effective...very realistic to use...you can buy your own laser for 2-4K or you can go to a chiropractor and they might charge you 30-50 a session if I remember correctly...very noninvasive, won’t hurt her, and all I’ve ever heard is good stuff...obviously nothing so far is a cure all but this seems damn close... my Dr. buddy needed a new shoulder and couldn’t lift his arm above his head...he did 2 sessions and hit his shoulder from 4 angles and I shit you not he was having free range of motion the next day and his pain was gone in like an hour...it’s definitely worth a shot...
Hey Fireman, if your having joint issues I know for a fact cold laser therapy is legit...after a few treatments it’s wild how fast your joints start to feel great...this in combination with 1000mg of omega 3 fatty acids EPA/DHA daily and glucosamine chondrotin sulfate version at 500-1500mg daily will make a world of a difference in many different joint related diseases including ligament and tendons...it’s pretty sweet...I was skeptical at first but I’ve
Seen about 100 dogs who were about crippled and don’t have placebo effect first hand get better with this approach and able to get of western meds...and I’ve seen quite a few people have the same response...anyways, hope you get better amigo
AVXL eggs and bacon
With all do respect, your comments are delirious, he was pretty straight forward in answering investor questions and gave very rational and reasonable explanations to our approach, timelines and where our future is heading. You want to get ride of Bruce Bouchy after 3 recent WS wins too I bet...This isn’t a conventional approach, if you want that then buy some Hershey or Colgate...maybe Coca Cola...JonJones gave us a very thorough post explaining everything that was discussed at the share holders meeting and Jon went away feeling a sense of peace with our approach...Dr. M is literally re-inventing CNS approach to mirror what’s going on in cancer research...taking a long cumbersome billion dollar old school approach and turning it into a streamlined rapid, cost effective approach...so naturally if your business is the template for success then it would be expected to have the FDA micromanaging and playing an intimate role in development...
AVXL woot woot eggs and bacon
Whether you believe in Dr. M or not, or are not sure what to believe, one thing is for sure, we will get a real good look at how Dr. M and the BOD will handle adversity. This is a big test and the first part of this test will be the ASM on the 17th....I for one am going into it with an open mind so as to be objective...I think we own him the right to explain what’s going on, where we are going and why we are here waiting still....I know a lot of you are frustrated, but I would hope you wouldn’t make knee jerk reactions until we have heard the man out...he has come through every step of the way so far, albeit not a fast time line but never the less what he has said so far seems to happen even if it isn’t at the pace we would like to see....IMO there is more at play than just what we see at face value...I’m sure the meeting will open our eyes one way or another. I may be wrong but I’d like to think he will deliver the goods and we will all be feeling bad for giving him so much heat....and if not then everyone is free to make their own decisions. I personally would like to hear a solid time line and an announcement on Rhett’s at the very least, and maybe some clarity as to why the delay has been so long as to see people on this board get peace of mind we have the right guy driving the truck....I think we do, but then again you can’t be 100% right 100% of the time...
AVXL it’s go time
Doc, what you seem to think is incompetence, I call genius...your talking about a management team who took over a failing company, restructured it and found a way to make it have direction and an end game....doing this all the while without selling itself out, getting debt free and creating a positive cash balance....then able to convince another government and charities to help fund there goals (I.e. spending other people’s money to get us enough results to be able to create a legit p3. Remember, The 2a/2b results were never meant to show efficiency rather safety of the drug and in doing so they clearly found the drug has positive benefit enough to data mine and set up a legit double blind randomize study to be pursued without spending billions to do it....most CEO’s would have had to partner by now or sell off the company. There is a reason fidelity has this as a strong buy, we are the way of the future and if our team was as bad as you think they are our company wouldn’t even be on their radar...precision medicine...streamlined to get just enough info to setup trials to succeed all the while doing it faster and far cheaper...We have to start thinking outside the box (like our management team has with the amount of money we have to spend) and the masses need to start realizing precision medicine is the future, so interpretation needs to be with this mindset....from this time forward A.I. And data mining will replace the need for massive investigational trial arms....your working with Dos still when you could have an I-phone...
Go AVXL
I couldn’t agree more Jimbo...it is easy to be an announcer and see the play the way it was intended for the quarterback to run it....it’s extremely hard to be the quarterback who has to run that play when other players on the field are influencing the outcome and you have to adjust that play at real time game speed...Say what you want but Personally I don’t feel he is a liar...he has moved this tiny company along at a slow rate yes, but you got to remember there are many outside influences, many irons in the fire and we are dealing with developing a template for CNS research in the future to follow in precision medicine....If Dr. M is guilty of anything it is being a bit to optimistic on timelines and believing a bureaucrat, taking him at face value....I seriously doubt any of you could do a better job given the little amount of resources we have to work with IMO. So yes, I’m gonna give the guy a little slack until there is actually a real reason to jump ship or the science doesn’t pan out...
AVXL
He Talon, yeah, it’s terrible...I just don’t know how a person can be so obsessed with money and power that they are willing to allow harm to befall upon the masses they should be looking out for even after they are already wealthy.....I believe with great intelligence or position of power comes great responsibility and those people should hold themselves to a self imposed higher moral code...but unfortunately people do exist who have no conscience or soul...
AVXL
I forget who said it but I agree there is a good chance we get some updates communication before or at the share holders meeting coming up on the 17th? What do others think? Just seems logical as a CEO you would like to mention something positive before talking to all these share holders who are wondering what’s taking the extra time to start these previously talked about trials...it will happen, let’s go AVXL!
A few theories for silence...1.) to get our foot in the door for our IND approved approach for endpoints before we get louder so our road to success is set in stone before highly influential people who want to see us fail are able to kill our chances of success before we ever start....I mean if your a small guy in a bar fight with a big guy do you want to let him know your gonna punch him before you do?...best way to do this is to not let them know your there until your there...then if we are able to prove our endpoints to be true it is
Much harder to deny our entry into the big boys club....2.) behind the scenes agreements or backdoor deals/MTA stuff 3.) Worried about legality of speaking to much...
AVXL
Not sure if you were asking or telling but it’s my understanding that a lot of manipulation of small companies in biotech occurs via naked shorting or counterfeit short positions...if the news isn’t what they want the SEC and DTCC, etc... have the ability to scratch the backs of their rich cronies by allowing for the spontaneous abrupt creation of more stock than a company actually has out in circulation to be used to sell short...I.e. as the demand goes up they can falsely increase supply to collapse the price or control the price action using fake stock positions and even when stock owners haven’t sold or authorized the use of their shares to be involved in shorting...basically it’s a legalized, look the other way corruption at its best approach for the super elite to fix the game...and since AVXL isn’t in the pockets of big money Wall Street financing we are subject to these attacks until we sell off, collapse or havea major break through with major backing which shuts off the attacking...easier to make money off destroying companies than aiding in there development and development of innovation...which is sad to think how much this has slowing down real progress in science and how many people have died which could have been saved if science was able to grow without egos and greed involved...
AVXL
Let’s go!
I would agree, Most people don’t want to deal with a room full of grumpy/frustrated people...if they have something ready to go I would think there would be a mic. Drop before 17th...Otherwise Dr. M will be swing his sword left and right in defense of a mutiny...I have faith in his logic and abilities and I too would like to see more transparency, but I also am a realist.....Stock holders aren’t going to be in on all the close door discussions....it’s not realistic nor would it be productive...to many chefs in the kitchen situation...Even though it has been slow, things are still moving forward.... with so many irons in the fire it will take a lot of time to manage each one like it should...most drugs are doing one thing and we have a rare situation we’re one drug is unlocking a lot of potential doors...so naturally it will take time to investigate each door thoroughly....
AVXL
Hey guys, I can understand your frustration and I think this is a general feeling from the entire general population when it comes to how slow the FDA use
To be and how costly running trails had become....Biotech is a slow moving animal...like a sloth compared to other areas of the market which run at the speed of a cheetah in their advancements. Science and discovery in theory should be exponential and our scientific community as a whole has been held back from rapid growth (IMO) at the cost of human lives in order to pad the pockets of greed...this has been why so many scientists have wanted to update and streamline the approval process...we were dealing with an antiquated system....running DOS when we clearly could be using Windows...say what you want about Trump but the change that came with him to the FDA looks like it’s going to be a breath of fresh air...hang in there fireman, I know this is not happening at the speed you would like but those returns you were talking about will be chump change if all goes well this year...everything we want is happening, just slower than all of us would like amigo...hang in there...
AVXL
Solid point powerwalker...that would make a lot of sense as well...either way I am of the mindset it is a legitimate reason...major nonprofits/governments don’t hook up with fly by night companies...thanks for your input...
I think those are valid thoughts for sure...the way he is delievering the message isn’t being received well? So could that be A.) the big money wants to just see more data before they fully commit? B.) They don’t understand the new precision medicine approach and are stuck on the old way of evaluating C.) think our product isn’t what we think it is...Am I missing anything... I would agree I don’t like the silence treatment, but I got to believe there is a legitimate reason for the silence...I know you don’t want to put to much weight on any one persons character because they can let ya down...but I think I’m going too continue to believe in the science and the captain on the boat as he has gotten us in a cash positive position and is helping us use this small amount of cash to leverage a number of big moves...A few of the guys have actually meet Dr. M...you can tell a lot about someone when you chat with them...Did anyone have any gut feeling about the trueness of his message?..I too very much enjoy your insight...Your gut feeling is usually right and although it could be gas, my gut feeling says we are sitting on a long term winner...will be in a great spot with this company!!
Go AVXL
I understand your concerns but without knowing all the pieces of the puzzle you are basically being an announcer would be to a quarterback who doesn’t know the game plan....If you were CEO what would you like to be do different? Please talk in specifics not generalities? What I see is a CEO who tells us stuff as it comes available, is traveling all over talking to who ever will listen or allow him to give a talk both financial and scientific communities and is even going as far as to buy more shares (something CEO’s don’t typically do when they don’t believe in their own company...There are a lot of legal things I’m sure he would love to say but he can’t because of FDA involvement and MTA still outstanding...So if you could elaborate on specific things that you would like to see him do that would be awesome so as to enlighten myself and other group members.
Thanks,
Mongoose
Hey Xena, I think what we are seeing here are two different interpretations of what is considered significant data....there is the academic purest which must have all the data plots satisfied before they can see something for what it is in front of them and have to rule out all the zebras before they can call it a horse...and there is the realist he/she sees what is most likely a horse short of extreme outliers but goes through the motions of confirming what he/she most likely already knows in order to stay objective....When you see 6 people over 109 weeks who are stable and doing well with a disease which has never had a drug which stabilizes AD disease, in a disease where placebo is not as critical (IMO) and the study wasn’t even designed to show this yet... common sense says it becomes very unlikely to be some statistical anomaly...is it possible yes...is it likely no...it s more likely these patient changes are significant than the other way around...
Go AVXL
Haha, the only German I know are bad/dirty words taught to me by a foreign exchange student buddy of mine from high school...I would agree, and you bring up some important points which definately should give us all pause...and with pause I’m always trying to look at both sides of this coin.....why would he hold back and the answers are either A.) what was previously mentioned or they are B.) fraudulent and because I find fraudulent to be very unlikely because there are to many scientists involved (scientists are by nature whistleblowers usually), large non profits/governments involved and multiple independent study’s at play...the answer has to be (A) by default as an elaborate conspiracy theory is far fetched...I think we just have to be patient and he will break the silence and we will all see it was for a reason...on a brighter note also we are trading sideways despite the markets getting hammered...news is very soon, I can feel it in my bones..
AVXL long time...
I would agree with Dr. M needing to be a bit more open to the stockholders but I also believe 3 things are playing in to this silence issue which will be resolved soon as I would be shocked honestly if we didn’t get approval for Rhett’s...
1.) He has been burned in past with being to forward with his thoughts so I do think he has over corrected and hopefully will realize this soon.
2.) Silence can be an important part of the game in warfare of the governmental pen type...atleast until approval of Rhetts’s has validated our company and allowed us to better protect ourselves from outside pressures which would like to see us fail...I.e. Trojan horse...he will become much more talkative post Rhett’s I believe..
3.) his primary language is German so I think this does effect on some level the communication... Americans are different types of investors (good or bad)....haha
I think we will all be pleasantly surprised this year...if not well it was worth the risk...but I think we will be throwing high fives this year...
AVXL let’s go!!!
Hi Nidan 7500, as it always is we formulate opinions based on the info. in front of us at the time A question is to be answered knowing it can change as science often is a circular learning field...I feel though there are times in life when some people can see a cloud long before it rains and know it’s going to rain...whether it’s raining gold or garbage...We all interpret information based on our different backgrounds/ risk tolerance levels and then decide if it is worth the plunge...I personally am very comfortable taking on higher risk when I see science/tech and socio/economic ground breaking events which have the potential to swing the needle as you have the chance to use very little leverage to create significant wealth...for example many people could buy a lot of AVXL at these prices and if it goes away...well maybe you lost the car you thought about buying...but if it is what you think it is, then you can retire...if that makes sense...rich people don’t get rich playing it safe, the play it safe to stay rich....Anyways, There is always a period of that can’t be, it can’t happen and then holy shit I better get on the train It’s real..I.e. adopter phase is always full of conflicting view points...and disbelief then wide spread acceptance and mass adoption and then man I could have bought that shit and been rich..but I was to scared of the unknown ...a great example (in my opinion) is blockchain/cryptocurrency which is in adopter phase currently of financing 2.0...people are not realizing how real this movement is I believe...you have the talking heads doing what they do best to allow big money to get in first...even going as far as to talk bubbles in a movement which wall st. Is just know sipping their toe in...I believe in AVXL for a number of reasons and I will try to answer you questions best I can...
1.) The timing of government motivation couldn’t be any better. There has been a major change occurring in the FDA which is geared towards precision medicine and an updated approach to drug approval process as to make it more streamlined and less costly...there also is a dire need for the government to find a solution and is highly motivated to fast track a drug which can solve the issues our company is addressing because of the burden it is going to put on the Goveremts pocketbook in the future...
1.) CEO= he has taken a company that once was in free fall and in a few short years gave it direction, a positive cash flow with no debt on the table...and a clear direction creating novel partnerships in order to use other peoples money (governments/nonprofits) to supplement our goals which would realistically not be possible if taken at face value with our current cash position...he and the BOD have designed a precision medicine approach using bio markers/genetics and most likely trials which build upon themselves as a way to minimize cash output and maximize potential of approval....the downside is it is a small company which has to step cautiously and deliberately in order to survive...so the things are getting done just not at the speed that is ideal...TFD does inform us as stuff comes up but has been burned already with PR stuff so I believe he is taken a step back and communicating as safe as he can...Yes he thought we would be starting already and I have no reason to believe he is lying as he has a lot to gain from this company being successful...If you do a character search on this guy he checks out legit.
3.) Our major competition and larger companies are failing and falling out of the race and we really only have one other realistic competitor in Neurotrope but it’s drug is I.V. And has an unacceptable safety so if it were to be used it would have to be in smaller doses and partnered with another drug (IMO)...The Amyloid theory is a dead horse being beaten...it may aid in a collective drug approach but isn’t the way of the future...some people will do anything not to be wrong and I think that is were big business is with this approach...Type A’s have a hard time admitting when they are wrong...
4.) Humans and mice neurologically are very much the same with very small differences relative to all the metabolic differences which exist in all of our other organs...this means what works in mice neurologically has a high probability of working in us...then we actually saw signs of efficacy when the study was designed to test safety and we still have trial subjects over 109 weeks out stable which is really unprecedented...yes you can talk probabilities but reality is it is much more likely the drug is working then not...sometimes you got to turn off your science brain and use common sense...
5.) we are being more than recognized, backed by well known people like Dr. George Perry ( who has a pulse on this industry) and we are adding people to our BOD all the time which are reputable people in there fields(people don’t risk there reputations and character on smoke and mirrors) non profits MJF, Rhett’s foundation, Wayne state, Australian government...and an MTA which is currently active still with Biogen ( which logic would say is a good thing as if it wasn’t
They would have dropped it a while ago most likely...) Commonsense tells you with this many people involved fraud is very unlikely...
6.) you have patients and caregivers who have begged the company to extend its early trials allowing there loved ones to continue to get their meds...people don’t do this unless they see something good happening and let’s be real, placebo effect in a person who forgot they even took a pill? And if they remembered they took the pill than keep giving it because it is working....commonsense...
7.)I expect we are going to have an announcement real soon even though we have been delayed as our IND was filed with an FDA which was being reorganized at the time and we most likely had to make some small adjustments which is to be expected...next we will have announcement of a short trial to start....I would then expect to see what we already know, the girls start to have
Dramatic changes for better with their seizures and overall quality of life leading to approval for Rhett’s...we will then see movement forward in Parkinson’s and Alzheimer’s at the same time we see off label use of the drug after this previous approval...then as we are going through the motions of the other trials the world will start to realize before their eyes how well our drug works making it fast track to multiple use approvals giving our company a shit ton of value allowing us to then develop and further refine our pipeline and partner with others...at this point you are saying I told you so while you sit on the beach drinking/smoking something which makes you smile...
7.) I personally will be looking at the obvious standard ways we evaluated ALZ scores wise...but also, what are the patients and caregivers seeing? How is the overall quality of life? Is this patient wandering the halls at night or actually sleeping? Did they remember seeing grandpa 30 mins ago? Real life application is important in this disease...some diseases your looking at numbers only like cholesterol and others are a combination of factors...and then finally, what is the interpretation of the scientific community? So far it is all positive and every study done has only added more support to the story which is AVXL...
Have a good one Nidan sorry for the long message.....eggs and bacon
You are entitled to your opinion and us to ours....so thank you for your concern but I understand the science (as I am a scientist myself) and it is real...along with many other world renowned scientists who feel the same way many of us do about this company...when you have elite level scientists, preliminary studies coming out of multiple respected institutions which are all positive, and backing coming from big name non-profits/governments...maybe it would be in your best interest to rethink your position rather than the other way around...but good luck with your decision...as I am very at peace with mine...any new budding science always carries with it inherent risk and this is the risk I am willing to take to see where this science goes...
I would agree, their approach is surgical....they are following the new face of FDA...The FDA is finally going to start moving more like the other branches of our scientific communities...Finally we will have a view of what’s best for our health and society, not how can we make money off of their health and delay anything which might get in the way of lining our pockets...breath of fresh air
I think there is a big difference between inept and methodically slow...this management team has put us in a cash positive, no debt situation along with strong science...this is a small company so we don’t have the luxury of being loose with our cash reserves...they know they have one solid shot at this being great without having to rely on outside help...so our team has in a brilliant way figured out how to use precision medicine on top of having donated dollars from non-profits/governments supplement our cash reserves in order to run a trial which has a very high probability of success based on its basket style approach...I would hardly call this inept...but I think you could call it methodically slow....a lot of investors on this board are very savvy; and we all know the type of science our company has in its hands is potentially life changing for many...we also know our BOD/CEO are invested in this company with their own personally stories and are leaders within their perspective fields; and the last thing I would think is they are all backing a company (putting their reputations on the line) which has science that has been backed up by many other outside scientists, and they are all in cahoots to back door us in a ponzu scheme...so go sell crazy somewhere else, I’m all stocked up...
Go AVXL
So the serious investor can keep chasing the tau and amyloid theories, that's fine, and realize this is a failed theory as the big companies who are pulling their money out of the space have already figured out...I'll stick to investing based on the credibility of the science, which only has two realistic horses in the race AVXL and Neurotrope...I will bet on AVXL because it is easier to give, far better safety margin and has aligned its stars with success (follow the scientist, follow the money, follow the government involvement = AVXL)...I also will chose to believe the earth is round while the serious investor can keep chasing the earth is flat approach...then we will see who is right...good luck, maybe the world really is flat...
Go AVXL
The fact Noble has our CEO in the mix with a handfull of others in CNS to talk about their platforms as well as ours; at a major meeting of the minds, shows the science community takes this company seriously...so all this FUD is manufactured drama just like most of the news we watch...I hope new investors will realize they are getting a lot of potential value fora minimal risk when it comes to playing the game in the ever so risky biotech arena...I loved watching the body language of that most recent Noble feb. 2018 event...just like watching a Texas holdem game...the big talkers presented strong when they were rather weak and vice versa held true as well....life is cards...go AVXL...
Polar, your right on...I remember researching it a while back but I believe it was like 1% of all Alzheimer's patients can have a long delay in signs progressing...so knowing these patients are mild to moderate, not way early i.e early to mild...it is statistical hogwash to believe that all of our patients and the 6 super responders happen to be in this 1 percent...is it possible ya, but it is far more likely that A273 is legit...The FUD can be real thick...I would much rather bet on the odds we have than the 1%...common sense will take us a long ways...if industry leaders in genetics along with people like Dr. Perry are interested, reputable non profits, governments not only backing us but also interviewing our CEO....it is a stretch to think some 1% theory has any legs...could zombies happen...in theory I guess, but seriously how realistic is it right? We have a winner in AVXL and it will take a little while to convince people the world is round....that is what our next step is going to do...
PS...Sweep the leg
Steady.......So adding to last post, I.e. Those with lower concentrations really we are missing there peak concentrations because they are happening between the time intervals preset for blood drawls...I hope that all came out ok?
Hey Steady, I was pondering your last response and two thoughts crossed my mind...1.) we should see a peak with a steady decline and with the time frame of 1/2 life drop and conversion to active metabolite it sits perfect for dosing intervals I think...also...2.) the difference or variation could also be due to transition to active metabolite happening faster in one individual vs another and then receptor affinity occurring faster than blood draw intervals....a classic example of this is seen with a process called the symogyi effect with diabetes...so when first regulating diabetics you can actually see this happen...so say diabetic guy X has a calculated starting dose of 6 units...so you give him six units then you check the blood concentration of glucose at 2 hours and blood sugar is 400 instead of 100. Then you say well you need more insulin and every time you give it the dose stays high...then your thinking insulin resistance but actually the real reason is an overdose of insulin occuring so the blood sugar crashes and rebounds real fast and high within the first hour but your testing interval is missing the wild swing so it only appears to be high, high, higher...thus I guess my point is this may only be a blood drawl timing issue and really the real gap isn't that wide because the process is happening way faster in some individuals than others...ps...thanks Steady, I always enjoy trying to find solutions because nothing is impossible, just hasn't been figured out yet
Hey, hey Fireman, In theory the right probiotics would support the presence of the right bacteria or I should say symbiotic bacteria...your right about fitness with cardio being key....I wouldn't worry so much about lung cancer...you might be at a slight increased risk but there is a big difference between inhaling carbon and inhaling cigarette smoke which is full of carcinogenic goodies like arsenic...it might happen but I would bet your dedication to fitness and healthy living will offset...I would probably be more concerned about bronchitis/asthma and COPD...but if your breathing well...woot woot go get em...
AVXL let's go!!
Hey Steady, I got a chance to look at it and your right, it's hard to really look at each plot but I think I understand your question....correct me if I'm wrong but your wondering why there is so much variability between each individuals plasma drug concentration per time unit from one person to another right ? I think what your seeing can be explained and is simple but also complicated if that makes any sense...when a drug is infused, the rate of infusion plays a role as well so I'm going to assume the rate of infusion was identical in each person; because if not you can get varying concentrations within the blood volume within the vein used...I think what you have to focus on is the general trend at this stage (in my opinion) because we are talking about a small pilot study...when you are talking about a population of people there is going to be quite a bit of variation within drug concentrations per volume of blood per time unit between individuals will vary even when all patients are experiencing positive effects from a drug and infused at the same rate....why is this right? Well the drug concentration per time unit, when comparing individuals is going to vary due to many factors....these factors include but are by no means only limited to these parameters: vascular permeability, regional blood flow, cardiac output, perfusion rate of the tissue, ability of drug to bind to tissues/plasma proteins, lipid solubility hydration status and pH partition....(most drugs pass through brain via passive lipid soluable diffusion through the blood brain barrier...also if small enough through small aqueous channels and facilitated transport)....knowing at high levels we see signs of dizziness, etc. with a2-73 we know it gets in the brain most likely because it is a lipid soluable or lipophilic chemical and crosses through the cell membrane via diffusion...so real world things like one persons circulation being better than another's, person X having a higher Body fat percentage than person Y (so drug is hiding out in tissues easier/harder), hydration status, whether or not they had recently ate (fats/proteins in blood which drug can bind too), varying amounts of plasma proteins/ plasma fats per volume of blood, speed of liver metabolism, speed of drug loss through other organs (like damaged nephrons in the kidneys of one old guy vs another), female vs male and blood brain barrier issues which my be from previous head traumas, etc...so when I read slide 13 I'm seeing the distribution drug concentration and then looking at what the general trend is and what is it eluding too? The phase 3 will be were you get much more feedback and can then comment in an informed way...right now I look at it at tell myself if it acts like a duck and quacks like a duck then it's probably a duck ...so phase 2/3 are telling us that yes it is a duck if all goes well...Steady T I hope that answers the question better...
Eggs and bacon
For sure Steady T...I'll take my best crack at it...give me a little time to sit down and look it over a bit closer....
Hey Fireman, for what it's worth I think they have indeed found a link between blood concentration and dose related response...so as a scientist myself the next step would be to work out what is effecting the blood concentration levels which would either be an uptake problem from gut in some individuals or and enzymatic breakdown happening faster in some people...so the two logical places to look would be the liver and gut first...with the gut you would be looking at bacteria, translocation mechanisms... In liver, is there a pathway of consumption/degradation....a good example of this would be the difference in alcohol consumption....some people can drink like a fish because of alcohol dehydrogenase enzymes being abundant and others lack them or have smaller numbers so the blood levels of alcohol stay higher for longer...so what I have taken out of the extrapolated info. Is A2-73 is a game changer but we need to figure out how to preserve integrity of the molecule while stabilizing the relationship between dosage and effect per unit of dosage change...so to achieve this, it may be a symbiotic bacteria that is lacking in some people, an enzyme lacking in gut or to much of a particular metabolic enzyme in some people...this can then be solved in a few ways in my opinion...those which can respond like our super responders then just take oral...the others may have to take a modified version which either allows for uptake or prevents/slows down metabolic breakdown/half life, or may have to introduce a specific bacteria to gut to aid uptake or maybe take a suppository...I say suppository because in the rectum the arteries go straight in to circulation...I.e. Bypass the liver were by helping to minimize first wave effect of liver metabolism...eitherway we have at minimum the building blocks for major quality of life change in the CNS space in A2-73...if this wasn't the case you would see many other respected scientists saying much the same as they are saying about the plaque-amyloid/tau theories and how they aren't going anywhere...and you would have the BP's full court pressing negative press, etc...It's my belief we are moving slower than a typical large company trail because we have a small cash reserve to make sure it's all done right, there is a big ideological change happening in FDA which effects us with guidances directly, and as a small fish in a big pond we are hiding in the weeds from the big fish until the timing is right for acquisition or going it alone...hard to think but there isn't a big gap between big Pharm and government so we got to play the game wisely or lose because of some policy change designed to stop the train of hope...unfortunately greed is real and not all politicians really care about their constituents as much as we would like to think it's not the case....stay the course longs, we have a real drug here I believe and we are getting 100% value for half the price...
My understanding is the first patient will be dosed once we have gotten approval on the previously submitted IND, which would go through minor adjustments phase brought about by the FDA...unless I'm missing something then the FDA's final approval of the IND for Rhett's is still in flux....I don't see how you can say the FDA isn't playing some role in the delayed roll out of Rhett's patients being dosed...Are you guys seeming something differently than I?
Happy New Year All!!
I am obligated to stay until there is a real reason to no longer be here...if you believe in the validity of the science, then you must be patient and wait out the process as everything to date as far as the validity of the science has been overly positive..there is also a changing of the tide occurring in the FDA which is favorable to our future goals as a company, and we do have a top notch BOD/CEO (which some might debate) but are poised to do great things through their connections. Just remember this CEO has taken a company on the brink of failure to a no debt, cash positive company with 3 trials about to start and a bright future if all goes well. If we have the goods like we all mostlly believe, then the CEO is right by being tight lipped and methodical about each step. The big companies want us to fail or misstep so they can get us cheap, you would do good to remember this, as Wall Street is a big game fixed by the big boys to profit...We have 3 trials about to start, it is frustrating waiting, but they will start...I would rather be delayed then hearing the trial failed because we rushed to start. Your naive if you think big government isn't what's slowing the process down, big government doing what big government does best...get in the way of progress until they figure out a way to profit. Hold fast longs and leave or stay based on solid information i.e trial failure, etc. A valid reason to jump ship....otherwise I don't see one yet.
Good question N2deep. I just emailed him to see what his current position is and if it has changed. I also asked what made him join neurotrope..I'll let you know what he says, but he does have a pulse on this disease and the current studies as well as being well respected by his peers... I try to look at the bigger picture and not put to much weight on one opinion, and to always stay open to changes of opinion as new information develops...I.e. My personal opinions are always evolving. It will be interesting to see what he has to say.
I'm operating under the assumption the reorganizing and shift in policies at the FDA, along with having to develop new approaches and then disseminate this information is the most likely reason for delay...we had a design plan prior but most likely it would have had to be refined once the FDA released its final design policies.most likely with Ariana involved they are trying to design the different trials so that each one builds on the other as far as information so the micro-management initially I believe it to be expected...Remember we saw unexpected results for the good in our P2a so loading the deck for a strong P3 is the right move. This company has the goods but because they don't have big money to back them if they make a mistake so they are dotting there i's and crossing their T's...Missling has kept his word every step of the way and he said they wouldn't move forward if they didn't have the goods...I'm giving him a free pass with the trials starting late as it's most likely on the FDA...but hopefully it is a learning experience for Missling with future decisions to talk with his shareholders about start dates...
It's not a conspiracy theory to think the FDA wants AVXL to hold off until they are ready...there is a major change happening within the FDA which appears on the surface to directly involve AVXL and its novel approach....Dr. Missling has told us his game plan and I trust he has our best interest in mind because five reasons...1.) he doesn't get paid the real big money unless the stock price goes up, 2.) he has been directly effected by the disease, 3.) he has taken a failing company which was in debt. And created a company with no debt, cash in the pocket and a clear direction, 4.) they companies goal was to make A273 fail in phase 2 and if they couldn't make it fail then get as much information back as to be able to tailor a successful phase 3 with the best chance for approval...since we are moving forward, in my opinion we are going to succeed because the drug didn't fail phase 2...phase 3 is merely for confirmation for the FDA....5.) very reputable doctors within the field are jumping or board along with reputable non profits like M.J. Fox....people don't risk there reputation on stuff they aren't sold on...this company is legit this will continue to become more and more evident soon, even though it is hard to be patient....