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Thanks, looks like we are in for a rough patch unless we get ++ news.
Hi Xena, the first 10 mins or so shows 2x the normal daily volume and of course yesterday was off the charts. You usually have this kind of thing figured out. I am hiding and watching this hoping we not now obligated to do the daily tree shaking exercise again. What is going on in your opinion?
I think there is some reason but the cloak of silence is down.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm609647.htm
This may be a factor in why we are up so nicely today.
Posted earlier by another poster here. This reads a lot like an FDA Mea Culpa about their processes and related reversals. Dr. Gottlieb may feel obligated (June 4, 2018) due to serious and obvious FDA process management issues which we have discussed here (BP/Amyloid-BC/Chemo.
It's all about process and details. Some stealth PR's are follow up to process changes such as this. Obviously FDA have not completely thought this out based on a quick read. IMO, this FDA release has consequences, we just do not know what they are yet. But, good news is all in AVXL process wheelhouse while BP is just so screwed. Got to be a factor. Just consider how much of a turnaround in the AD space has occurred in the past 3-6 months.
Many thanks to the other poster for finding and posting it.
Perhaps news.
Looking..Great catch here:
So do the introduction of new scientific domains into the development and review process. This includes the more widespread use of modeling and simulation, the greater use of real-world evidence in the pre- and post-market setting, and the adoption of better tools for collecting and evaluating more real-time safety information after products are approved.
even after products are approved
Hey John....I am w/you on the direction, would prefer teens (x20+) ...all the best.
June 4, 2018
Developing Topic* abstract notifications sent via email (to the presenting author)
* Unless the research is considered to be late-breaking, Developing Topic abstracts will only be considered for poster presentations. The majority of Developing Topic presentations will be scheduled on Wednesday, July 25, 2018.
One good thing about the precision medicine approach/thought process is that the sponsor is expected to have a rational, fact based story to tell.
That compared to 20+ years of, let's take some population of known sick people and try XXXXZZZZXXX. And, If we try a big enough sample we should get some responses, and if we have to we can just expend the sample size. Hey, what could go wrong?
BTW, it looks like the breast cancer (very wealthy sponsor) Chemo people have hit a wall a lot like the Amyloid guys. Huh, well, "never mind the Chemo is not required, in fact it might be harmful" my emphasis. Maybe getting them to stand down was done a lot like the Amyloid guys.
Getting technical facts to support a thesis and then demonstrating efficacy is not an easy thing to do, but it will be a lot cheaper to do, faster to determine if/when real progress has been made and that it is sustainable. All of this comes from knowing what you are doing, vs shotgunning. And, when you are done you can actually use the results to learn something positive. Ain't science grand.
Based on history most conference PRs come a day or a couple days before the conference
June 4, 2018
Developing Topic* abstract notifications sent via email (to the presenting author)
* Unless the research is considered to be late-breaking, Developing Topic abstracts will only be considered for poster presentations. The majority of Developing Topic presentations will be scheduled on Wednesday, July 25, 2018.
This text from AAIC site. Does anyone know how this process has worked in past? If AVXL to present will they do PR soon? Based on history...when will that happen?
Biostock....nicely done...thx.
I wouldve bought a boatload at $2.....hindsight is 20-20 ofcourse.
What do you think is causing this jump?
So will Rett's approval trigger Angelman's trial?
We know people respond. Now we just want the most responsive
http://www.anavex.com/wp-content/uploads/2018/05/Anavex-Presentation-May-2018-1.pdf
This new summary set is impressive. I would encourage anyone who has not yet done a quick scan to do so. Very, very impressive with convincing technical focus.
Special slides that got attention #13,29,33.
I also really like the theme connecting "precision medicine" to trial success rates. " Utilizing precision genetic medicine to treat severe neurological Disorders". This suggests a positive, direct link to knowledge being applied in targeting CNS disorders.
I know people at various regression levels who are experiencing CNS disorders (PD, MS, PD, other). Their families basically have come to live with the belief that nothing can be done. Anavex is giving (to me) a different kind of message which presents a refreshing, positive, precision science driven problem solving attitude. This is the opposite of the shotgun approach of the past XX years. Some days, attitude is all we can give and it matters a lot.
Read what they have done here also note the RS IND message.
If Missling presents the genetic data along with complementary 2 year data, we could get a nice pop
Wrong again:
Truly sad and disrespectful to the people that spend their lifetimes to save and prolong our life.
there is no divine interventions here just science and logic.
You need to go look at the accidental start of the era of antibiotics. What did happen? Why was it significant? Research Lab results Should have been ignored (according to your thinking), not supposed to happen. Old Pharma massive trial methods have proven nothing about discovery, reproducibility, yes. Predictions of certain failure are now recognized by even the BP thinkers as evidenced by their abandoned Amyloid trial methods. That is all they proved. BTW, these massive trials were carefully done according to methods you would no doubt find acceptable.
If one trial being conducted to evaluate safety resulted in some num. of patients(even one) actually reversing their dementia progression, then that result must be understood. According to your thinking these results mean nothing and must be ignored or somehow rationalized away. Had that happened w/Fleming and follow ups then antibiotics discoveries would have had to wait for some conventionally acceptable method. The very best researchers see things that should not have happened and then work to understand WHY. When a breakthrough happens (as possibly in A2-73 AU safety trials) ignoring the results that should not be there is not OK. You will soon see (AAIC-2018) the beginning of CNS disease treatment evolution.
You may also soon start to see the term "Binary Event" being used.
But in the era of personalized medicine, where care can be tailored to a person’s genetic make-up and doctors analyze a patient’s DNA
handwriting is emerging on the wall
AVXL board challenge.
Answer this question w/facts:
Will ANAVEX be presenting as part of the upcoming July-2018 AAIC conference in Chicago? What will the title of the presentation be?
Note: AAIC says they will notify authors on June 4, 2018.
Prize to winner: A 50 round box of 0.45 ACP 230 gr.
According to Sagient Research Systems, H.C. Wainwright’s team is ranked as the #1 Placement Agent in terms of aggregate PIPE and RD transactions cumulatively since 1998.
why does this sound familiar?
Also saw that AAIC in Chicago in July will be sending notices to candidate authors on June 4 (next week-unless late breaking). If this is the conference Dr.M. keeps talking about then this could be an interesting period for changes. Sure am glad I do not own any of the amyloid plaque pushers stuff.
Let's not wait and do this again w/A2-73 etal
Alexander Fleming’s Discovery of Penicillin
Penicillin heralded the dawn of the antibiotic age. Before its introduction there was no effective treatment for infections such as pneumonia, gonorrhea or rheumatic fever. Hospitals were full of people with blood poisoning contracted from a cut or a scratch, and doctors could do little for them but wait and hope.
Antibiotics are compounds produced by bacteria and fungi which are capable of killing, or inhibiting, competing microbial species. This phenomenon has long been known; it may explain why the ancient Egyptians had the practice of applying a poultice of moldy bread to infected wounds. But it was not until 1928 that penicillin, the first true antibiotic, was discovered by Alexander Fleming, Professor of Bacteriology at St. Mary's Hospital in London.
Returning from holiday on September 3, 1928, Fleming began to sort through petri dishes containing colonies of Staphylococcus, bacteria that cause boils, sore throats and abscesses. He noticed something unusual on one dish. It was dotted with colonies, save for one area where a blob of mold was growing. The zone immediately around the mold—later identified as a rare strain of Penicillium notatum—was clear, as if the mold had secreted something that inhibited bacterial growth.
Fleming found that his "mold juice" was capable of killing a wide range of harmful bacteria, such as streptococcus, meningococcus and the diphtheria bacillus. He then set his assistants, Stuart Craddock and Frederick Ridley, the difficult task of isolating pure penicillin from the mold juice. It proved to be very unstable, and they were only able to prepare solutions of crude material to work with. Fleming published his findings in the British Journal of Experimental Pathology in June 1929, with only a passing reference to penicillin's potential therapeutic benefits. At this stage it looked as if its main application would be in isolating penicillin-insensitive bacteria from penicillin-sensitive bacteria in a mixed culture. This at least was of practical benefit to bacteriologists, and kept interest in penicillin going. Others, including Harold Raistrick, Professor of Biochemistry at the London School of Hygiene and Tropical Medicine, tried to purify penicillin but failed.
Back to top
Penicillin Research at Oxford University
It was Howard Florey, Ernst Chain and their colleagues at the Sir William Dunn School of Pathology at Oxford University who turned penicillin from a laboratory curiosity into a life-saving drug. Their work on the purification and chemistry of penicillin began in earnest in 1939, just when wartime conditions were beginning to make research especially difficult. To carry out a program of animal experiments and clinical trials the team needed to process up to 500 liters a week of mold filtrate. They began growing it in a strange array of culture vessels such as baths, bedpans, milk churns and food tins. Later, a customized fermentation vessel was designed for ease of removing and, to save space, renewing the broth beneath the surface of the mold. A team of "penicillin girls" was employed, at £2 a week, to inoculate and generally look after the fermentation. In effect, the Oxford laboratory was being turned into a penicillin factory.
Meanwhile, biochemist Norman Heatley extracted penicillin from huge volumes of filtrate coming off the production line by extracting it into amyl acetate and then back into water, using a countercurrent system. Edward Abraham, another biochemist who was employed to help step up production, then used the newly discovered technique of alumina column chromatography to remove impurities from the penicillin prior to clinical trials.
In 1940, Florey carried out vital experiments, showing that penicillin could protect mice against infection from deadly Streptococci. Then, on February 12, 1941, a 43-year old policeman, Albert Alexander, became the first recipient of the Oxford penicillin. He had scratched the side of his mouth while pruning roses, and had developed a life-threatening infection with huge abscesses affecting his eyes, face, and lungs. Penicillin was injected and within days he made a remarkable recovery. But supplies of the drug ran out and he died a few days later. Better results followed with other patients though and soon there were plans to make penicillin available for British troops on the battlefield.
War-time conditions made industrial production of penicillin difficult. A number of British companies, including Glaxo (now GlaxoSmithKline) and Kemball Bishop, a London firm later bought by Pfizer, took up the challenge.
Once again, we have an affirmation that 2-73 has therapeutic benefits in early stages of the drug's research:
https://www.alz.org/aaic/abstracts/overview.asp
Other info....
Abstracts submitted Jan 29, 2018
Topic notice sent to presenting author June 4, 2018
Submissions Posters Only unless considered "late Breaking"
My own notice-observation: It looks like a majority of the topical papers/posters in 2017 mention or refer to Amyloid in the title. It will be interesting to see how many this year will include amyloid in title line.
I am a day away..
I will plan on going
jmv...thank you...AAIC -July-Chicago. Looking forward to news between now and then also. Anyone w/connections/sources should go on the point for us.
For Alzheimer's, the big one seems to be the AAIC which will be held in Chicago 7/22-26.
Likely upcoming conference news (AD/RS/PDD) A2-73?
What are the best thoughts on when/where Dr.M. will be doing next major conference A2-73 presentation?
What conference? Why? When? Where? Other?
Not sure the analogy holds water.
CNS advertisements, it's a crap shoot.
It's always good to see Falconers posts.
Wouldn't it be nice if we didn't always have to speculate what's going on "behind the scenes?"
I'd prefer AVXL get the damn trials started
Yup, we'll se I guess. There was shown a definite correlation between the drive to 2$ sp by posting irrational harassment here and the index date. In the future longs should remember this.
FDA Commissioner Scott Gottlieb ...“believes he can provide the safety through regulation that might otherwise be missing” in the Senate bill, Walden said.