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.
The markets are still bearish. Pretty hard to swim upstream.
Do your DD. Read ALL the publications on Anavex's website.
How do you know? AVXL soared to $14 w/out trial results.
What do you like about AVXL so much that you devote hundreds of hours to following and commenting on it?
You, and everyone else, very well knew what I meant by 'mirror'. I shouldnt have to spell out the full context of how I used that word, it is implied, It of course isnt meant to be taken literally as a mirror image of the market, rather, the up-down gyrations and trends are similar.
In bear markets, small cap, illiquid stocks fall quicker and further than the overall market or their sector, hence, that is why they are called volatile. Reverse is true in bull markets. I thought this was common knowledge.
AVXL mirrors the IBB and NASDAQ plunge. That is all. AVXL going down mostly has to do with the general stock market going down.
How do you know? There is no index for micro cap biotechs. NTRP, for instance, is down exactly 70% since last summer.
False. Most small and micro cap biotechs have been in a down turn
Biostock, are there more western women with Alzheimers because they live longer than men and chances of getting Alzheimers increases as you age? Have you, or the papers you cite, accounted for this?
In those 3rd world countries you cited (India, Cambodia, etc), is the incidence of Alzheimers the same between women and men, or do women experience it in greater numbers just like in the West?
Are there less numbers of Alzheimers in the 3rd world because life expectancy is lower, so they die of other things before they even have a chance of developing diseases of old age (Alzheimers, Parkinsons, etc)?
Oh brother. So Anavex has to cure all 3 diseases, or else it will go bankrupt?
FYI - Every Dr is taught that in medicine "nothing is free". What that means is that every drug has side effects. You might get x,y, or z benefit from a drug but it usually comes at a cost, side effects. The question is, is do the benefit(s) outweigh the costs/side effects? Anavex has said in the past that the potential CNS side effects of mild to mod dizziness and headache often go away over time as the patient's body ajusts to the medicine. And then there's the issue of whether mild to mod dizziness is worth it if 2-73 stabilizes Alzheimers or has some other major benefits. The patients that were moved to a lower dose, it is quite probable that they could work their way back up to higher doses. Selecting patients w/wild type biomarkers also reduces the chances of side effects.
Great post sokol! Must Read for everyone!
And what are the names of those two completely different neuron types?
It is unexpected that the average scores of a group of Alzheimers patients w/both wild type Sigmar1 and COMT genes improve after 57 weeks for both mmse AND adsc-adl. To say improvement in average scores for BOTH measures for such a group is expected to be >50% likely is not true. Alzheimers is a progressive, degenerative disease that is 100% terminal 100% of the time. MMSE scores drop 2-4 points/year.
Harald Hampel would not have written and said what he did, nor flew to Chicago, merely to report results that were clearly due to chance, as you assert. Preclinical work also supports what was observed in the clinical trial.
BTW, what are your scientific related credentials (education and career track)?
Anavex said the reason for delaying trials was the unexpected biomarkers being identified by Ariana. This info wasnt delivered to Anavex til late last year.
The trial sites would have been the same regardless of changes taking place at the FDA.
I can't explain that. I'd expext that line to be at 1.7, not 0.3, since delta, I thought, means change. I must be missing something, or perhaps it's an oversight on the part of the graph maker which slipped by Anavex, Ariana, and Hampel et al. Or perhaps the PR is wrong. I doubt they made a mistake however
How do you and Peter figure only 61% remained in the trial?
Which graphs? I'm assuming you're focused on the graphs on slide 14. Let's focus first on the graph on the left side of the slide. Both the orange and green bars have thin horizontal lines appearing on them. Do those lines represent the average, mean, or medium change in mmse? Let's assume average. Anavex's PR said for the sigmar1 wild type group, its average mmse improved +1.7. The thin horizontal green line on the green bar is at about 0.3. Subtract 1.7 from 0.3 = -1.4. -1.4 is above the thin orange line on the orange bar which is positioned at about -2.8. Even if we take your advice and use the score of the sigmar1 variant group as a reference, adding 1.7 to -2.8 yields only -1.1, which is below 0.3. Repeat this exercise for the adcs-adl graph and you'll get results which also don't jive w/what you've stated.
From Anavex's PR:
But Anavex said in their PR the average scores for the Sigmar-1 wild type group improved +1.7 for mmse and +3.9 for adsc-adl compared to baseline.
10mg/kg mouse dose corresponds to a 16.6mg human equivalent oral tablet
By "common gene variant", did McFarlane just mean a gene variant that all the super responders have in common w/each other? You're interpreting his quote to mean that the gene variant is commonly occuring in humans
Anavex has said its pipeline may treat strokes.
A Ca++ influx, doesn't that cause muscular contraction (ie vasoconstriction)? That decreases the diameter of arteries which raises BP. Magnesium has the opposite effect on muscles.
Why they so quiet? They all covered up?
Is Anavex a biotech or pharmaceutical company, and why?
I've read conflicting definitions. The pharmaceutical industry is twice as big as biotech. I've read biotech companies produce their drugs by using biological organisms (bacteria, yeasts, etc) or products, such as enzymes. Those drugs are called biologics. I've read biotechs are often smaller companies that are doing research and often haven't even brought a drug to market yet. Pharmaceuticals are generally bigger companies that are selling drugs and making money. Their drugs are generally small molecules (like Anavex's drugs).
Usually, I've read or heard Anavex described as a biotech company.
You have to compare apples to apples. Why are you comparing mild AD patients to the mild-moderate patients in the Anavex Ph 2A trial? Are the mean ages consistent? Improvement is more reliable if it is seen across several measures, not just one. This was observed in the Anavex trial. I wouldn't take the results from one or two studies and apply those to how every patient with AD would respond. Half the Anavex Ph 2A trial patients weren't even on 30 or 50mg. Those on 10 or 20mg probably could have taken the 30 or 50mg doses with only mild side effects at first, which probably would have subsided over time. But they weren't allowed that chance b/c Anavex wanted to track dose-response.
Did the early Aricept trials see 15+% of patients on Aricept increase their scores over two years?
Your wrote that 1/5 of AD patients taking a placebo improve their scores over 2 years. Where are you getting this information? One trial, or does every trial involving mild-moderate AD patients reveal that 1/5 of those patients taking placebo improve their scores over 2 years? Age of patients is also a very important factor to take into consideration.
What exactly was the guidance(s) and how in practical terms does that effect Anavex's upcoming trials? The FDA's news release seemed pretty sparse and vague to me. I don't see any specific set of 5 clearly defined official guidances that will directly effect the design of Anavex's trials near term.
Wait, so Anavex has not yet submitted the updated IND yet for the Rett trial?
What bothers me is that there is an assumption being made that if Alzheimers patients aren't kept stable or improving indefinitely, then the drug is a failure. Unlike donepezil, memantine, and all the other Alzheimers drugs on the market or in development, why is 273 being held to such a high standard? Why must it stabilize or improve the disease process and symptoms indefinitely to prove it is useful? Has anyone considered that it might be worthwhile even if it just slows the downward spiral of the disease for a time or lessens a symptom of the disease for a time? Treating an incredibly challenging disease like Alzheimers or Rett is not black or white. It isn't a cure or bust proposition, even if some people portray it that way. To give you an idea how challenging these diseases are to treat at all, the biggest pharmaceutical company in the world, Phizer, last week totally abandoned its efforts to address them. It liquidated an entire division of the company, laying off hundreds of researchers. Given the track record of failures, even seemingly small victories in this space are worthwhile accomplishments. It is great that half a dozen or so patients experienced stabilization or improvement long term while on 273 without side effects or adverse events. However, 273 has probably helped some of the other patients in the trial as well, but that has been left out of the discussion entirely.
And keep in mind, patients can be rx'ed other meds to help lessen any side effects from 2-73, such as pain relievers if they get headaches. That is not an uncommon practice. If the side effects are only mild or moderate, they might be able to be addressed with otc meds like Tylenol or ibuprofen.
Think of this logically. Firstly, lets not equate mild to moderate dizziness or headache with bleeding in the brain, brain swelling, and near death experiences. When trial subjects experienced mild to moderate dizziness or headache, Missling said that is a sign they are approaching their MTD, NOT BEYOND THEIR MTD! There's a difference. Nonetheless, the trial immediately lowered subjects doses if they were experiencing ANY side effects, no matter how minor. If they had given the subjects a choice, some or possibly all would have elected to stay on the same dose hoping: A. they could tolerate the side effects or B. the side effects would diminish over time. Many, if not most, people taking meds put up with accompanying side effects. EVERY drug has side effects. For some drugs (chemo for ex) they are serious, but worth enduring. This is especially true for debilitating illnesses that are terminal, such as cancer or CNS diseases such as Alzheimers, Parkinsions, ALS, Huntingtons, Rett, etc. If you're gonna lose your faculties and then die, it might be worth it to you to put up with mild dizziness or headaches.