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Does it matter that the Anavex trial enrolled adults instead of children? I assume both trials were of equal duration?
The reason anavex delayed trial progress by A YEAR was to increase chances of getting our drug approved for diseases bottom line. Precision med increases chances by 10-15%! Will analysis of trial results take into account the different and new approach in the cns space anavex is taking, or will the pundits assess our results, and chances for the drugs approval, the same way they do for traditional cns trials which don't do any precision medicine investigation?
Is it possible, the drug, given early enough, could halt or slow down deterioration? Would that alone make it worthwhile? That's all donepezil maybe does for maybe 6 months
Keep in mind Anavex's Ph2 trial was just 7 weeks long, dose was just 5mg, and subjects were adults, whom are harder to treat than girls. Avatar will be using higher doses and Excellence focuses on girls. Percy failed to make those important distinctions.
Anavex uses precision med, Cassava doesn't. That = smaller n required, less time to enroll, better chance at approval. Nobody on soc media respects precision med
Do you think the pandemic is affecting enrollment into clinical trials of vulnerable subjects that might be hesitant now to make trips into a medical center? Has Anavex had to make clinical trial adjustments to cope w/the unique demands of the pandemic? Chris gives "best case scenario" estimates, however, things come up, unforeseen delays usually happen. I always add several mos delay to his timeline predictions. Problem solved.
NASD & DOW have been hitting new 52-week highs, every day!
That is false. NASDAQ hit a 52 week high just 2 days ago and prolly is gonna today, but otherwise its performance ytd has been rather anemic. AVXL's performance ytd? +138%. NASDAQ's? +1.84%
The nasdaq has gained <1% this year and biotech (IBB) is flat ytd. That means most biotech stocks haven't done much this year, yet you expect avxl to be soaring despite that and no avxl news. smh
What do you think Doc, 6 or 7 more years of waiting til *possible* approval for Alzheimers? Do you still set fda approval for Alzheimer's at a 25% chance?
At the end Missling said he considered the 2b/3 AD trial as "pivotal." That would only be possible if it were to have a strongly clinically meaningful effect.
Anavex has done a ph1, ph2, and current ph2/3 for alzheimers. They feel the drug 273 can get approval based on the ph2/3 results w/out need for ph4. Does fda require pivotal trial take place in usa in order to approve a drug?
IMO, there is little chance of approval based on one 450 patient study so Anavex will do a phase 3 including US sites if results are good in the smaller study.
Don't need em. If all the avxl retail investors bought up avxl large on a given day, they could roast the shorts
Looks like he's a liar too. He never wrote any articles analyzing AVXL
Looks like Acadia Pharma is under investigation. Neuren licensed their Rett drug in trials, Trofinetide, to Acadia for hoped for future N. American sales. Shuman Glenn & Stecker Investigates Acadia Pharmaceuticals, Inc.
15.1% of A273 patients dropped out of the PDD study due to treatment emergent adverse events compared to only 7% of the placebo patients.
Past is prelude. Still awhile b4 larger Ph3 results available.
I anticipate this (approval) will be just before or during 2023.
Why wasn't this quote included in your original transcript?
Sure about that? No mention of seizures in tradherpete's transcript. rett transcript
I hope 2-73 is more than just a feel-good psyche drug that helps w/mood and sleep. It seemed like Randi H. spoke mostly about 2-73's apparent psyche effects. I wish she would have mentioned fewer seizures, less hand wringing and fidgeting, better coordination, more communicative, etc.
I think the stock will dip down into the 5.60's or 5.70's.
What are the "pk" patients in the trials (I know pk = pharmacokinetic)?
Just 3 more years *if* Anavex can beat the odds, and that's a big if. Meanwhile the market goes up another 50%.
clinicaltrials.gov didn't reveal dose of Avatar study. It said it's just 7 weeks. It said,
Intervention Model Description: 33 participants: 3 PK open-label followed by 30 double-blind, randomized, placebo-controlled.
Are the two Ph 2 Rett trials basically identical, just one's domestic, the other international?
It might mean that the 6 open label PK patients that have been exposed to A2-73 much longer shows better results.
What is the difference between these two comparisons?
ANAVEX®2-73 treatment yielded a statistically significant, drug exposure-dependent response in the RSBQ Total scores, when compared to placebo, in the ITT cohort (all participants, p = 0.048).
66.7% of ANAVEX®2-73 treated subjects showed a statistically significant improvement in drug exposure-dependent RSBQ response as compared to 10% of the subjects on placebo in the ITT cohort (all participants, p = 0.011).
What news from DC?
I'm a little surprised no run-up leading up to the PR of the Rett results.
So precision medicine is "cherry picking" huh? Not quite.
By 'introducing', I meant introducing 273 into the cell (for ex, by taking a pill). Capisce? #context
That was mostly a perfectly fine statement, but SR1 does "wake up" and come to the rescue whenever cell is under stress, at any age, and for whatever reason. Introducing an exogenous SR1 agonist, like 273, can 'goose' that process to put the the SR1 on steroids, so to speak, to rev up the cells own self defense mechanism. Introducing 273 is like in the movie Fast & Furious when the cars' drivers hit the nitro button in the final stretch to give their cars a turbo boost. Maybe Missling shoulda explained it that way for the American audience Lol, but that's not his style.
According to your post from last Sunday,
The CDR attention battery, comprises three brief but highly sensitive tests of attention: simple reaction time, choice reaction time and the digit vigilance task.
Broad and statistically significant improvements in CDR system Cognitive Domain of Attention assessed by Choice Reaction Time (p = 0.039) and Digital Vigilance (p = 0.008)
Which cdr-coa components were missing from anavex's ctad presentation?
Any chronic illness, or chronic pain, compromises sleep and mood. It would be nice to take something legal and non-addictive for that that doesn't make you a zombie, get you high, or scramble your brain. Bonus if it alleviates pain.
Diseases in which mitochondrial dysfunction have been implicated include Alzheimer’s Dementia, Parkinson’s disease, Huntington Disease, Amyotrophic Lateral Sclerosis (ALS), intellectual disability, deafness and blindness, diabetes, obesity, cardiovascular disease, and stroke.
Over 50 million people in the U.S. suffer from these chronic degenerative disorders. While it cannot yet be said that mitochondrial defects cause these problems, it is clear that mitochondria are involved because their function is measurably disturbed.
Even autoimmune diseases such as multiple sclerosis, Sjogrens syndrome, lupus, and rheumatoid arthritis appear to have a mitochondrial basis to illness. Mitochondrial dysfunction has also been associated with a wide range of solid tumors, proposed to be central to the aging process, and found to be a common factor in the toxicity of a variety of physical and chemical agents.
8% more of the wt only subjects were in the top interval after 14 weeks of 2-73 than the wt's + variants on 2-73 were at 14 weeks. 8% difference can make or break a trial and is significant. Not too shabby results for the group receiving 2-73 considering pdd is degenerative, as demonstrated by the placebo group.
Has Anavex said if will be giving any updates and data releases on its Ph2/3 Alzheimers trial before final results are presented sometime in 2022?