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Thank you for your excellent work and sharing!
And you are not?
I'm sick and tired of seeing your propaganda for years after years.
This board is mainly for the investors of Anavex Corp.
Well, there are sumtruesumfalse on the internet. haha
I back-up xodcode's opinion with my observation: My 9 year old No-revenue-bio-stock Watchlist lost 95% to 99% of its value; it includes:
INO, ONCS, ADXS(congrats! today), ATHX(add Q now), BCLI, SNGX, TNXP. etc. Some of them are still tradable with 99.8 % loss; I just don't know how they still keep the office. Now I realize that I should be thankful for Dr. M.
Copied from other board:
I understand that there are people who make $5.95 per reply so I can appreciate their attempts to post comments that will draw a reply. Good luck to them but I won't contribute to someone's income who is doing a despicable thing for a job.
Yes. There is a way to block replies to your ignored people.
Profile Settings >> My Ignores
Remember PPS was around $2.5 in most of 2019 and till Mar 2020 when I sold a half of my position at $2.4 because I was mad at performance of AVXL. I regretted later. Most of you longs had survived through that time I suppose and now we are at $5.36 4 years after. 50% gain every year for 4 consecutive years. Do we have more risk or less? Just saying......
an article dated on Jan 2.
That’s very positive thinking in this dark tunnel where we don’t see the end. ha! That would be the scenario for the longs who still are holding on their shares. I thought we de-risked pretty much till Rett fiasco on Jan 2.
Btw, you forgot to mention the EMA route.
No worries as you had been one of my iggies already anyways.
$5.95 per reply nowadays I hear?
So what actions did you take?
Suing the company or Fighting on a stock message board? Just leave and leave us alone.
Good for you. Hope that turn out good eventually.
Fellow longs turn sour one by one and sell theirs. That's sad.
Yep, and I will say that it’s the darkest before the dawn.
GLTA
You sound like you want this go down to $3 so that you can reload. Lol. That’s ok I can understand.
That’s funny. You are new to this board and you said so few times already. Great job.
What a mess.
And then he came to Anavex.
Thank you.
“No news from Australia where the whole thing began and the RWE comes from.”
That’s what I thought.
Awesome! Thank you for your work.
My comment, if you don't mind, is that you add acronyms only relevant to Anavex and bio-stock investing from now on.
Not like LOL. LOL
Thanks but the link does not work.
Feel bad to see you go. Yeah.....many have lost trust in Dr. M but are hanging on to the company.
I know hoping is not a good strategy but there still are many aspects, developments I can hope for.
Wish you the very best!
Yes I did. Still trying to gather what his analysis shows. Hope he is right. Thanks.
Now I'm nervous we haven't had that crystal clear moment regarding its effectiveness, but there's so much awesome insight generated by SOTC and others. Hope springs eternal and ..................
That's probably how many longs feel now including myself. Some of them even got sour as you see.
And, as a guy who's been bald since 18, I have no problem with TGD's hair ;)
You were hilarious and understandable as I have a brother-in-law who's been bold from collage years. : )
Welcome on board!
GLTY
Hi go avxl! lol lol lol
I’m waiting for falconer66a to update the list with more acronyms that he and others added. Thanks.
That's a good idea; my list so far:
sorry I lost spaces between texts as I cut & pasted
Ad Comm Advisory Committee of FDA
ADCS-ADL Alzheimer Disease Assessment Scale- Activities of Daily Living
ADAS-Cog Alzheimer Disease Assessment Scale- Cognition
AGM Annual General Meeting
BLA Biologics License Application
BTD
CNS Central Nervous System
CRO Contract Research Organization
CRL Complete response letter.
This is a response from a regulatory agency after submitting the NDA saying the drug is not approved but that it is approvable
if certain studies are performed or more data is reported or manufacturing issues cleared up.
CTN Clinical Trials Notification. This is the Australian equivalent to the FDA's IND or the EMA's Clinical Trials Application. Based on pre-clinical studies including PK/PD, toxicity, carcinogenicity, teratogenicity, etc and any human data if available, companies apply to be allowed to do clinical testing in their country or union.
DMT disease-modifying therapy
EHR Electronic Health Record
EMA European Medicines Agency
GCP Good Clinical Practice
HREC Human Research Ethics Committee
ICH International Conference of Harmonization. Regulatory agencies from practically all countries have now signed on to use standards and guidelines developed by the ICH and in accordance with GCP (also formalized Good Clinical Practice) to perform clinical studies. A clinical trial in the US is performed practically the same in the EU or AU allowing international large studies. Regulatory agencies use different abbreviations around the World and may have some built in requests but the clinical trial is performed nearly the same in all countries.
IND Investigational New Drug
IRB Institutional Review Board
LPLV Last participant's last visit
MAA Marketing Authorization Application
NDA New Drug application. The FDA and TGA use NDA and EMA uses
NDA Non-Disclosure Agreement
NICE National Institute for Health and Care Excellence(England)
NIH National Institute of Health
MAA Marketing Authorization Application (for EMA? ; comes after SA)
this is the application including detailed data from all studies that will be evaluated by the regulatory agency to decide if the drug can
be approved and marketed.
MMSE Mini-Mental State Examination
MOAs Mechanisms Of Action
MTD
OLE Open-Label Extension
OR. Odd Ratio
PDD Parkinson's Disease With Dementia
PK/PD
PTA Post Trial Access
RSBQ Rett Syndrome Behavior Questionnaire
RWE Real World Evidence
SA Scientific Advice (for EMA : European FDA)
SAP Statistical Analysis Plan
SPA Special Protocol Assessment
stat sig statistical significance
TGA Therapeutic Goods Administration (FDA equivalent of Australian government)
TLD Topline Data
TLR Topline Record
You know him?
The quotation is from Jul 2020. He could expect, couldn't he? Anyone has the right to do so on this board. His expectation was waaaaay more conservative than many others on this board back then.
I appreciate your cool headed, educated opinions on this board but your occasional personal attacks make me frown.
Good write up as usual. Thank you.
I’m in that same boat.
My strategy here is to keep my hopes up, sigh, till…....
Do peer reviews always produce good results?
If not, they’ll not be PR’d I suppose. Or the company can choose to put it on a PR.
I meant that what does Anavex have as a bio-company at this point for investors to invest in. I know there are other indications but they are years away…. I hope Anavex can submit AD application for EMA this year.
So what’s the value that Anavex has now for bio-stock investors someone like you? I’m not talking SP or MC.
Thank you for your reply.
Bas, so where does Sarepta stand now?
Did they fail and are still pursuing for a FDA approval?
SP dropped 40% to $63 on a bad news in Oct 2023; today at $98: a half recovered from the SP prior to the news.
I don't get its CEO said: “met the standard" to show "evidence of effectiveness.”
Maybe we can say that if Blarcamesine beats Acadia's drug for Rett?
Good info!!! Thanks.
‘FDA increasingly approves drugs without conclusive proof they work.’
Hope that’s the case for Rett girls and of course for us investors.
High volume today.
Thanks.
You meant 1500+?
Hope that's the next milestone.
Under U.S. law, there is no particular level of efficacy required for
a new drug to be approved. Instead, drugs with near-zero efficacy
can be approved, prescribed, and sold to patients who have real
and sometimes very serious diseases or conditions.
from the Introduction on page 5 of the article in the link: the article is 10 yo.
https://scholarlycommons.law.wlu.edu/cgi/viewcontent.cgi?article=4358&context=wlulr#:~:text=Under%20U.S.%20law%2C%20there%20is,new%20drug%20to%20be%20approved
Google sent me an automated notification: A post re: AVXL on Ihub NWBO board.
Maybe it explains how Lequmebi got an approval; on same token can Blacarmesine be for Rett or.........? Apparently someone had posted the article recently.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173549288
Can I add a quick question here since you are on it:
I suppose peer reviews don't guarantee a positive conclusion.
Could they find the trial had flaws and/or failed?
So screwing around with patients mRNA with a vaccine may have messed up the trial, ain'a'hey?
Hmmmm.......interesting theory.