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Looking good imo! Nice day so far $AVXL
Was reviewing some old notes today and for some reason for this year I wrote October/November 371..
I wish I had clarified exactly why.. oops.. my best guess is likely a simple guess (hope) on my part due to how long I expected additional research to arise. Does anyone possibly have a better answer? Skimmed some old news and couldn’t find anything specific but maybe I missed something.. possibly from a conference call?
Not much can beat clinical data at this point but a surprise 371 update would be great!
Fingers crossed
Can’t wait!
I have a feeling the holidays will be extra happy this year
Jmho
Good luck everyone $AVXL
Well said
We are entering a new era in terms of clinical studies imo and I believe Anavex realizes how important is it to hold their cards close to the chest at this point in time. No need for a repeat of 2015, that’s for sure!
WS has very little understanding of what is going on here and I believe that’s part of the greater plan. Once they have MORE than enough data, I bet the PR’s change to a much more layman friendly tone.
As for now, let the data speak softly for itself.
Great question - I’ll do my best to look into it
Btw
I don’t own any grve and don’t plan on owning any in the near future
On my radar though
Good luck everyone
Taking a look $grve
You could be right
But I’m hoping things will be different this time around
It’s very possible, in my opinion, that, at least some, shorts are quite ignorant to current events and are simply betting on past performance
May be trying to play on the fears and anxiety of the past
There’s also longs who wish to hedge their bets
The science is really all that matters in the long run
If this dips, I’ll certainly be picking up a few more shares
Good luck everyone $avxl
$AVXL !
Over 3$
Also notice, reference 421 is from 2007
Not the only mistake (swim found) - Reference 424 link is not correct https://doi.org/10.1038/s41392-019-0064-7 (2019) and/or I can’t find it
(Not a 2019 reference at least)
https://www.nature.com/articles/s41392-019-0063-8
Odd similarity to article’s own link
What does all the above mean? I really don’t know! And I don’t think it really matters all too much ..
It’s also very possible that last minute changes were made just prior or publishing
To assume anything, including that they may have had this information back in say March, is faulty logic imo.
What “mistakes” have been confirmed, if any?
Seems to me the real mess is the oddly large amount of FUD surrounding AVXL for many many years now..
I believe Anavex is nearing a point where it can shake off the FUD shackles and claim its rightful place in the scientific community at large.
Jmho
The article states “... granted fast-track status by the FDA...”
FDA - so not likely a mixup concerning anything Australian.
Jmho
Monday should be interesting!
$AVXL
Smells like news is in the oven!
Will it be ready this time next week?
I think earlier..
8/20? New site?
Jmho
Good luck everyone
$AVXL
Time to focus $IVITF
Just waiting and watching patiently like everyone else
Science continues to impress
Only a matter of time here imo...
That gut feeling!
$AVXL
Hopefully the beginning of a new green chapter here..
Looking good imo
$IVITF
Unnecessary perhaps for those familiar with Anavex but this news release could have been negative instead of positive/neutral
I don’t believe this is any sort of fluff
Simply keeping shareholders informed on new 3rd party findings/recommendations
To brand new eyes this is good news in my opinion
It’s interesting to see minimal reaction (seems the market has a bit more confidence in AVXL than it may seem)
All Jmho
Although they used the word efficacy it was not in reference to lack of or evidence of.
Simply stating that they explored safety and efficacy in order to recommend changes or no changes to the current design.
This is good news no doubt but I don’t believe they intended the word efficacy to mean anything but to explain their bureau approach and relatively neutral findings.
Decent news in my opinion
It could be argued that this was to be expected but it’s nice to see the science remaining consistent (in this case it’s safety) - especially from a 3rd party perspective
Wish volume was better .. but oh well!
Moving in the right direction $AVXL
All Jmho
Great link(s) thank you!
-
“213 This section provides general principles to consider in planning a drug development
214 programme. Efficient drug development usually requires appropriately planned interactions
215 with regulatory authorities throughout development, both in relation to planning early as well
216 as later studies including post-approval studies. This is particularly important for multiregional
217 studies to ensure the study design is aligned with regional regulatory requirements.
218 A drug development plan describes all aspects of the development of a product from the target
219 product profile through post-approval activities. The plan is usually prepared prospectively and
220 updated as the development progresses and new information becomes available. The plan
221 generally includes characterisation of formulation development, non-clinical studies required
222 to support the evaluation of the product in human clinical studies and to support product
223 approval, clinical studies designed to support the demonstration of efficacy and safety in the
224 relevant patient population, studies in special populations (e.g., paediatric populations),
225 regional considerations for product commercialisation (e.g., health technology assessments),
226 and post-approval studies.
8
ICH E8(R1) Guideline
227 It is important to ensure that the experiences, perspectives, needs, and priorities of stakeholders
228 relating to the development and evaluation of the drug throughout its lifecycle are captured and
229 meaningfully incorporated into the development programme.
230 With increased globalisation of drug development programmes there is a need to consider
231 factors that impact quality of a protocol when it is conducted in more than one region (see ICH
232 E17 Multi-Region Clinical Trials). Early engagement with regulatory authorities to understand
233 local/regional requirements is encouraged and will facilitate the ability to design quality into
234 the study protocol. The results of a study are often used in regulatory submissions in multiple
235 regions, and the design should also consider the relevance of the study results for regions other
236 than the one(s) in which the study is conducted.
237 Clinical development programmes may also feature requirements for co-development of
238 validated biomarkers, diagnostic testing, or devices that facilitate the safe and effective use of
239 a drug.
240 An overview of the types of studies that may contribute to a development programme is
241 provided in the table in Annex 1.
“Exploratory
• Explore use for the targeted indication
• Estimate dose/dosing regimen for subsequent studies
• Explore dose-response/exposure- response relationship
• Provide basis for confirmatory study design (e.g., clinical endpoints, patient reported outcome measures, effect modifiers, target population, etc.)
• Randomized controlled clinical trials of relatively short duration in well- defined narrow patient populations, using surrogate or pharmacological endpoints or clinical measures
• Dose finding studies
• Biomarker exploration studies
• Studies to validate patient reported
outcomes”
“448 5.1.1 Study Population
449 The population to be studied should be chosen to support the study objectives and is defined
450 through the inclusion and exclusion criteria for the study. In practice, the study population is
451 limited to subjects available to participate and for whom consent is available (see ICH E6).
452 Recruitment efforts should ensure that the study subjects reflect the planned population for the
453 study. If objectives include obtaining information on certain subgroups, then efforts should be
454 made to ensure adequate representation of these subgroups.
455 The study population might be narrowly defined to reduce heterogeneity and maximize the
456 sensitivity of the study for detecting a certain effect. Conversely, it may be broadly defined to
457 more closely represent the population for which the drug is intended. In general, studies
458 conducted early in a development programme, when little is known about the safety of the
459 drug, tend to be more homogeneous in study population definitions, and those conducted in the
16
ICH E8(R1) Guideline
460 later phases of drug development or post-approval tend to be more heterogeneous. Recruitment
461 for a precision medicine study, for example, may target the subgroup of diseased patients with
462 a particular phenotype or genotype, either exclusively or through an enrichment study design.
463 The choice of study population will depend on the study objectives, and the degree to which a
464 study succeeds in recruiting and enrolling the desired population will impact the ability of the
465 study to meet those objectives.
466 For example, a study population representative of clinical practice may be the target of a
467 pragmatic trial conducted within an existing healthcare system. In such a study, recruitment
468 procedures may differ from other types of studies, in that the inclusion and exclusion criteria
469 may be assessed based on existing medical records.
470 Because of the study objectives or because of feasibility or efficiency, there may be situations
471 in which the population unit is not an individual but a group of subjects (known as a cluster).
472 For example, some vaccine studies make use of cluster randomisation to measure their
473 protective effects on communities. The use of a cluster unit has implications for multiple design
474 elements and quality factors (e.g., intervention, analysis, consent).
475 The study should plan to have a sufficient number of subjects to make statistical conclusions
476 based on the findings either by obtaining a certain precision or by controlling the probabilities
477 of making false conclusions (see ICH E9 Statistical Principles for Clinical Trials). A larger
478 database may be needed to establish the safety of a drug (see ICH E1).”
Anyone attending the meeting today?
Great post
-
Thanks Dado
Ha!
Well said
... winter is coming
Possibly bitter sweet having my 3.01 fail to fill the other day...
Although I went ahead and added again today at 2.52 (what a deal! Right? Right!?), I’ll only allow myself to add ONE MORE time.
So.
Fingers crossed.
... Hoping this doesn’t go too much (or any!) lower.
(sweat rolling down my forehead)
~
Good luck everyone $AVXLong
That gut feeling...
Hug a stranger
Patience
And
Perspective
No, it doesn’t matter. And this being a sticky is quite laughable. Similar to a sticky telling everyone it’s going to rain someday without mentioning the seeds that have been planted. If one isn’t comfortable with dilution here then this is not the place to be. Not for beginners. This is a baby biotech attempting to fund as much as it can by itself in order to, IMO, greatly benefit shareholders down the road. I am might proud of management and, like the rain, dilution is absolutely normal AND nothing new here.
Not sure that was what the question was asking for..
How* did they pump it?
Another accumulation add today
@ 3.o8 $
$AVXL
~ ~ ~ ~ ~
Anavex 2-73 - and beyond •
Well.. I still believe once this gets traction we will see a 4$ rally with a strong $3.8-6 pullback support.. then $5 likely in our sights.. but, short term my gut says it looks like 2.8$ is almost certain with continued low volume
... Holding some serious powder just in case
$AVXL
Having serious discussions of events that might indeed pan out as described... is absolutely incredible. To say the least.
Even IF Anavex “fails” - there is now SIGNIFICANT new found hope in what have become very hopeless areas of modern medicine
Excited for the future, and very proud of Anavex’s management team
All jmho of course
Good luck everyone $AVXL
Patience And
PERSPECTIVE
March to 2020
Headed back up next week
3.5-3.8
Jmho
$AVxL
Looks to me like this will head up to 4$ soon then likely test 3.6-3.8 area as new support
Jmho
$AVXL
I agree
3.4 used to be a area of resistance
Testing as support is, pretty normal.
I wouldn’t even be surprised to see 3.2
Although, the chart gets a little worrisome (at least short term assuming little to no news besides normal patient enrollment and dosing milestones) if it dips and sustains below 3.2
As for the shelf - it’s a speculation.. good or bad there is NO WAY to know for sure. Luckily, this company is determined by its science. If 2-73 falls short it I would surely lighten my risk here, but it would be a hard sell for me to completely disinvest. I believe we are picking away at the tip of an iceberg. An iceberg that could very well change medicine, and possibly our approach to it, forever.
All just my honest opinion of course ~
$AVXL
Mitochondria - spark of life
Why has BR failed especially in regard to “complex” central nervous system and other diseases?
I believe Capra describes this well here: