Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
"
Nicely done...
bear...AGAIN, I find myself agreeing with your rationale and other thoughts on why we are where we are. It's the WHAT'S NEXT part that has us hanging by our fingertips.
We are looking at a potential binary event, no going back if A2-73 continues to perform. The platform science has been explained, the trial results have been published, plans have been carefully defined, resources seem to be lined up. It is a ONE or a ZERO, with evidence pointing to a massive win.
BTW, I also thought we stayed out of AAIC b/c with new FDA protocols being announced the context for any plans would be mixed at best. We cannot discuss what happens next until FDA defines new protocols.
frrol, thanks for grounding us again on how we got to this point re: RETT and going forward.
T-38, Honestly, I am not well enough informed on hostile takeovers to answer. I do believe that AVXL could get support/attention from public sector to prevent such a move based on the scope and importance of A2-73 potential. All IMO.
T-38...keep in mind that both the FDA and DC politicians are watching every move (IMO) very carefully. IMO, AVXL has a fist full of wild cards where typical unfriendly takeover practices are not going to be allowed.
I agree w/this observation.
Thx Good day, based on the FACTS you present for likely patent PR date would you speculate on when SP increases will start, Or at least some volume. Has everyone left town? IMO, today would be as good a day as any considering apparent nominal risk. I'm Just getting impatient...
Possible roadkill?
Alzheimer's News Today (info@alzheimersnewstoday.com)
Falconer, thought you might find this set of seemingly unrelated studies being published about possible AD links.
My thought was....HUMMM, does this set of widely ranging indications add to the discussion of CNS Homeostasis? Connecting the dots as you have suggested may seem obvious in retrospect. A2-73 tip of a massive iceberg. All the best.
trade volume looks slow this AM? 20K or s0 shares after almost 30 mins. Does last week of "summer" matter? Seems light/different?
Rey...agree w/this completely.
Exactly right Bear. Dr. M. would know what the data says and he would have had time to consider what it all means. Additionally, he has a better idea than the rest of us of what the context looks like. Schewart said, "Data without context is meaningless".
New FDA protocols will impact timing and reporting methods for new trials. The coming trials will likely not look like those from the past. New timelines and reporting requirements will likely drive SP to make old pass/fail gyrations look tame. We just do not know any of this stuff yet, but my guess is he at least has a clue on what to expect. We can only do a , "What If?".
It would be easy to become dramatic on near term possibilities where some serious CNS disease treatments show results never seen before. We all are pulling for the patients and their families, they have been through a lot. I am confident that good things are about to happen with A2-73. The curious part is, then what?
If A2-73 brings new science then great, we are long overdue. Breakthroughs have consequences. Old rules get turned upside down overnight in a good way. If we learn from history for examples, which I am sure Dr. M. must be doing, then he has no choice but to keep silent b/c no one would understand what he is talking about. They would throw a net over him.
TTT great thought, this type of over the horizon planning needs to be constantly brought forward. Eventually, it sticks.
I certainly agree with the predicted direction on SP. The faster and bigger increase the better for me.
Any idea what SP to expect when BP starts to act out/figure out what A2-73 and the whole MOA does? They are very smart, very active and fearless.
When new FDA processes and US Govt. reviews of Pharma costs get elevated by politicians BP are pretty much caught in the open. AVXL compounds will look like manner from heaven. Gives BP a chance to reduce investments in research and to reduce trials time and expenses dramatically on CNS(etc) across the board to act like they hear the $$$ problems(which BTW, they created). Looks like their agents will be buying AVXL w/both hands.
IMO, the timing of new protocols and simultaneous US Govt. scrutiny of costs puts them is a place where they are (at least temporarily) not driving the train. Just curious, part of the systems dynamics here if A2-73 comes even close to what we fcst. IMO, if PD and MS score with A2-73 we are looking at a situation which must be very skillfully controlled. Fortunately, Dr. M. spent his whole life with these guys and knows what to expect. A key point is that the medical benefits must be kept highly PR'd b/c there will be lots of smoke and mirrors. All, IMO, watch where you step.
Oldie but goodie...lots of moving parts around this Rett trial. But, we have done the homework .
Nice to see Rett trial information today. My guess is that most of us are waiting to see the rest of the story. Is this a new FDA trial protocol balloon?
This all looks more real every day. Most of us in Biotech have been bitten hard before, we know that anything can happen. Thanks to the Many here who have added real scientific/regulatory/common sense value to the collective knowledge base, we need that. We are getting more outside information which appears to validate the companies claims. The next few weeks look to be awesome. All the best.
Yep, that is my read also.
Falconer...Cannot tell you how refreshing and informative your comments here have been. None of us can see into the future with any precision of course but there are certain process triggers which, over time, pop to the surface and SCREAM...LOOK HERE. That has happened to me a couple of times over the past 30+ years, so I have an ear for them. IMO, Dr. M.'s comments on CNS Homeostasis is such a message. He did not say BREAKTHROUGH but the results did for me. Measuring breakthroughs using conventional techniques makes zero sense to me but there are those who insist we must continue to do exactly that. Planned changes to FDA guidance/trial rules are perhaps analogous to the processes you describe.
Your students were very fortunate, and so it goes. We ARE going to win this one.
From Google search on antibiotic history...an analogy might be useful.
It took 20 yrs or so to connect the dots on antibiotics. Is this about where we are with CNS Homeostasis? Precision medicine will provide process metrics along w/new FDA guidance. Can we anticipate a BP scramble to move the chains? IMO, the results will speak for themselves, except this time they will know enough to pay attention.(IMO)
Excellent...thx...pieces begin to reinforce each other...
[quoteStrengthening our partnership with patients, by providing funding for the development of the National Evaluation System for health Technology (NEST) to help pay for a NEST Coordinating Center and pilot projects. NEST is intended to facilitate the use of real world evidence to support premarket activities.
Establishing a flexible and more efficient path to market for certain new medical device accessories, to enable new and innovative accessories to come to market more rapidly and enable accessories to be used with a wide range of devices – creating important options for patients.
Creating a category of over-the-counter hearing aids which will help lower costs and enable access for patients who greatly need these devices.
Providing new opportunities for early consultation on the use of new surrogate endpoints.
Streamlining combination product review to enhance coordination and transparency between FDA and industry. ][/quote]
BINGO is correct.
Dr. M. (way back) started talking about CNS Homeostasis as a restorative/regenerative process concept. Fast forward. No prediction on exactly what happens then but ask the patients and care givers how it's going. Brilliant is correct. He will have leaped over the entire field of , "Yeah But's".
T-38 right on..
Bear, yes there is bound to be a LOT of juice flowing over the next few weeks. That bunch of BP interests who are being called out by our CRACK political force is not accustomed to being asked direct questions. I know from 30 years of dealing directly with them and part 820 compliance holders, including consent decrees, they do not take criticism well. They cannot be trusted from one day op the next to do what they said they were going to do. If we do go eyeball to eyeball it will not be pretty. But it is getting clearer to me that is exactly what Dr. M. has presented all along.
No doom and gloom, just keep your head up until it is over. If we do have the (MS) goods and they are given an offer they cannot refuse,(either name or brains on the paper) believe it or not, that is what they wanted to happen all along. It is how they roll. They wrote the book on hardball....not sure our politicians know what they stepped in.
Bear...today's news again points to a focus on MS by our crack political leaders. So, we are either set to announce work/partner with Biogen or to deliver a groin kick. Either way works for me.
https://finance.yahoo.com/news/biogen-6-other-multiple-sclerosis-133101020.html
I'm shocked...this suggests it's all about money and power/control. Huh.
Agree, Dr. M. is sending a signal to shareholders. He has consistently projected confidence in the A2-73 Homeostasis story for CNS restoration/regeneration. Agree also there is some connection between the PR silence, Biogen and possibly FDA trial guidance reset. Lots of moving parts here and lots of angst but it sure beats waiting 2 years for yet another plaque trial readout after decades of failures.
Yep, we have all been wrong before.
One cannot count on anything where BP and medical device people are involved. They are accustomed to winning. IMO, getting positive trials results does not end the (happy ever after) story. Elapsed Time/delays/spin and just about anything that gets in the way of crossing the finish line should be anticipated .
The old expression, "just because you are paranoid, doesn't mean they are not after you". Comes to mind.
Thanks for this...astounding to me that this point is passed over so casually.
Bear..agree
Cb...agree w/your platform belief comment.
I would also suggest that not only will we rally but I also expect (following relief/caution expression) that some results will be tough to verify in a classic trials context. Just exactly how will restored CNS cell functioning present itself? Do we expect Rett children to regain/gain CNS controls for example? Let's pray for that. These are really the least of our worries for now.
The gap between present AVXL SP reality and potential value is a mystery to me if not by design I have to admit. What explanation is there for this?
Huh? No planned dates for new guidelines implementation?? This is going to be very interesting. Thx Walker
BTW, the question is, does A2-73 restore CNS Homeostasis or not? And then what happens? If, Y then game over. Since no known patient has ever stabilized, much less recovered, form AD how is the question of statistical confidence even relevant. We miss the point if we try to debate/agree on n. That thinking is what got us the last 50 years.....zippo, nada, ziltch...It's a breakthrough. Have a great day.
OK...September 5th is your speculation. Thx, that works. As long as we get it out of the way before the 11th. Curious there are no triggers (must do dates) tied to a Gov. calendar.
Thx
Who knows the timelines for new FDA trials/planning/protocol. When will they announce the new rules? Is there an FDA requirement for publication of the rules and effective dates?
My guess is it must be before sept.11 but that is a guess.
Biogen adds $$1B in cap. based on this? kinda makes you wonder what a drug that really worked would be worth. I guess a LITTLE BRAIN BLEED is tolerable.
Tell me, if A2-73 performed like this would you be here? I would not.