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Agree with you, Wolf, but for the agency to pursue. Possibly meeting with TGA rather than fda on peds Rett and/or EMA/UK. It might be, those agencies will appreciate a 93.7% (p=.063) chance that 2-73 caused the improvement in the dosed girls, rather than the standard 95% (p=.05). In addition, there are the benefits of 2-73 in safety and living condition improvements in diarrhea, vomiting, food consumption, weight loss, sleeping habits, seizures, et al, when compared to Daybue's impact.
ANAVEX NOW ... RIGHT NOW ... MONO-STYLE ... for LIFE ... and for ALL AGES!!!
FYI - The Neuren/Acadia trial ratio was 1:1.
So, if Excellence were 1:1, would the positive numbers be more likely stat significant?
ANAVEX NOW ... RIGHT NOW ... MONO-STYLE ... for LIFE ... and for ALL AGES!!!
You are correct about my logic ... it never does anyone any good to respond to your posts.
ANAVEX NOW ... RIGHT NOW ... MONO-STYLE ... for LIFE ... and for ALL AGES!!!
McM, while I understand the logic that you can not compare trials of different drugs for the same disease, IMO that can be done when you look at the physical results of 2-73 and Daybue as to how the girls are living after taking one of the two. Life (QoL) is better for the girls on 2-73 (fewer seizures, much less diarrhea, vomiting, weight lost, more freedom to express themselves in communications, better mobility) than the poor Daybue girls.
ANAVEX NOW ... RIGHT NOW ... MONO-STYLE ... for LIFE ... and for ALL AGES!!!
Don't know, bas. I believed both theories were published via Alzheimer's & Dementia: The Journal of the Alzheimer's Association.
ANAVEX NOW ... RIGHT NOW ... MONO-STYLE ... for LIFE ... and for ALL AGES!!!
You ask for an explanation of why there were drop outs in the placebo group and I gave you one.
I'm finished with this. You ALWAYS need to have the last word, so I'll stop with this post re: this topic.
ANAVEX NOW ... RIGHT NOW ... MONO-STYLE ... for LIFE ... and for ALL AGES!!!
As to your opening sentence, the placebo girls drop out after 4 weeks because their parents and caregivers are able to tell there is no improvements from the baseline.
Your response in ¶2 shows that logic in biostats is not always logical. As to the ITT stats, not sure that is the best since it involves some extrapolation of how the dropouts would perform and what is the basis for that, those who stayed in the trial, etc.
Yes, I know that the placebo effect is for both arms, which is why 93.7%, i.e., p=.063, is still an impressive number.
ANAVEX NOW ... RIGHT NOW ... MONO-STYLE ... for LIFE ... and for ALL AGES!!!
🦡, one thing to note in JPM release: no mention of Rett pediatrics trial. Hopefully, Anavex is not stopping this effort as its benefits is so overwhelming to these girls as McM will point out, no doubt with which I fully agree.
ANAVEX NOW ... RIGHT NOW ... MONO-STYLE ... for LIFE ... and for ALL AGES!!!
My point is that if the dropouts were more than the 1:2 ratio of placebo to 2-73 participants and it was due to poor responses at 4 weeks, then the average placebo response would not have been as high as reported.
Also, in your last sentence, are you claiming the dropouts' scores are included in baseline though not in the final readings? I find it hard to make sense (or understand logically) how that can be. 😉
ANAVEX NOW ... RIGHT NOW ... MONO-STYLE ... for LIFE ... and for ALL AGES!!!
Thank you, Investor, for bringing up my question from yesterday, asking for this information to understand which of the girls were included in the 77.
1) Were there more placebo girls that dropped out, as they showed little or no significant improvement and drop out after 4 weeks with their numbers being excluded from Week 4 as well as Week 12? 2) Or was it equal in dropouts, 10 taking 2-73 and 5 on placebo? If the first question is "Yes", how was this bias factored into the stats?
Also, when did Anavex receive these numbers?
ANAVEX NOW ... RIGHT NOW ... MONO-STYLE ... for LIFE ... and for ALL AGES!!!
Thank you, T, for this discussion.
In effect, with a p=6.3, 93.7% of the change would be due to blarcamesine, instead of 95%, which is deemed stat significant, regardless of trial size.
So, the difference of 1.3 points is the equivalent of 1 girl's results out of 77 (1/77 = 1.2987%). One equivalent outlier is the difference in success or failure. Seems too exacting/extreme in such a small study.
Thanks to george, too, for his posts on what should be the range of stat significance and it does not always need to be p<.05.
Thanks again, T.
ANAVEX NOW ... RIGHT NOW ... MONO-STYLE ... for LIFE ... and for ALL AGES!!!
Haven't been able to read all 420+ posts today, so if my question has been answered, please be kind and give me your answer.
I realize this was not in PR, but maybe someone spoke with Andrew or Clint. There appears to be 15 girls not included in the stats, do we know what the make-up was of that group? If so, do we know why they aren't in the numbers? How is their absence impacting the numbers or it doesn't?
TIA
ANAVEX NOW ... RIGHT NOW ... MONO-STYLE ... for LIFE ... and for ALL AGES!!!
Thank you, Investor, for stating the filing may not be material ... regardless of your qualifying add-on.
As to mrp, I don't think the EMA was necessary a material event, but given that the EMA asked Anavex to file, if I were a lawyer, I would want my client to let the public know about it ... and you got a Rikker 👍️.
Otherwise, a Blessed and Prosperous 2024 to All!
ANAVEX NOW ... RIGHT NOW ... MONO-STYLE ... for LIFE ... and for ALL AGES!!!
IMO, the filing of an NDA is NOT a material event ... but companies are free to PR such a filing if so desired.
The fda's response, however, is a material one.
ANAVEX NOW ... RIGHT NOW ... MONO-STYLE ... for LIFE ... and for ALL AGES!!!
bas, you can do up to FIVE emojis during this Holiday Hour cease fire!
Go at 'em, Tiger!
mrp, that is what I remember, too. Maybe, frrol knows more than we know as s/he is blaming the Anavex clinical head for not staying on top of the CRO.
What do you know, frrol, i.e., any thing more than those two sentences from Dr. M??
ANAVEX NOW ... RIGHT NOW ... MONO-STYLE ... for LIFE ... and for ALL AGES!!!
So, mrp, do we know who requested the safety check? I don't recall if it were mentioned who made the request, but if you and/or anyone else does, please let us know. All I remember is one or two sentences that Dr. M stated in the year-end cc.
For all we know, it may have been the fda after one of the frequent meetings that it has with Anavex per the orphan drug procedures. Possibly, the fda did not believe the safety data could be that Good and asked for a re-examination of it.
If anyone has specifics on this point, please share.
ANAVEX NOW ... RIGHT NOW ... MONO-STYLE ... for LIFE ... and for ALL AGES!!!
Not to mention, X, the EMA progress.
ANAVEX NOW ... RIGHT NOW ... MONO-STYLE ... for LIFE ... and for ALL AGES!!!
Why don't you two brats in the sandbox, go to PM's through NYD since it is available and will spare the rest of us your infantile exchanges.
OT but a competitor - ANVS had options opened ~3 weeks ago, even though only 10 MM shares o/s. With the recent run-up, on no announced news, in the last week, and the option premiums suggesting a possible price above $25 in April, does it look like to our option gurus that ANVS is being set up for a sale? If so, is likely buyer BIIB or LLY?
bullet, you can also ignore responders of those on ignore.
Good luck!!
This is what the Company stated in its 2023 Q1 PR:
I read that are there are two p's quantified, both of which is under .025. Why is that then not successful? TIA
So, Investor, what is the basis in stating that endpoints weren't met when each of the p's shown are less than .025? Please explain. TIA
ANAVEX NOW ... RIGHT NOW ... MONO-STYLE ... for LIFE ... and for ALL AGES!!!
This might be passé, but has anyone sent the Rett Australia videos to the Reddit/Robinhood crowd as they showed interest in Anavex in the past? Just a thought.
Tred, regardless of the flack Dr. M gets on this board for not meeting deadline, NO ONE knows what is going on in the Anavex organization, especially those who are the most critical.
For all we, including them, know is that the TGA might have a moved blarcamesine to an accelerated status in Australia, which is offering encouragement to those in the know ... thus, the 3 videos.
Thanks, again, hnbadger, for finding those videos.
ANAVEX NOW ... RIGHT NOW ... MONO-STYLE ... for LIFE ... and for ALL AGES!!!
george, you should note, also, that each of those Strong Responders were
ANAVEX NOW ... RIGHT NOW ... MONO-STYLE ... for LIFE ... and for ALL AGES!!!
Thanks, hnbadger, for the recap. I don't do FB so I'm in the dark on the videos.
Any add'l info will be welcomed by one and all.
Ziggy, Anavex has a large enough size in the P2b/2 trial. Remember Biocr*p had only 300 participants in its submission for its adu*crap drug after the exhaustive review for any benefits. I think it had over 3,000 people in the trial.
My best wishes for you, Tred, in your sacrifice. Takes a big person to do all that you will be giving up during those 90 days.
You'll be missed by many posters here.
Considering these are work days, a drop from 210 to 150 is ~3 months. That's significant for those with AD, meaning they get the 2-73 3 months sooner.
SMH
Below was just released by NWBO re: MAA. Anavex might fall into this pathway, too, of 150 days.
https://finance.yahoo.com/news/northwest-biotherapeutics-announces-marketing-authorization-143000107.html
Read mine to Bear. The revenue is not 100% Anavex's; the revenue is shared via the partnership agreement.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173471477
... as does the market ... down 400 points in 35 minutes!
Bear, Anavex does not receive all that revenue as a portion goes to partner to cover those costs and its profit.
george, that is correct but it is NOT all Anavex's revenue as a good portion will go to its partner that is producing, distributing and marketing/sales in Europe.
boi, he is a bot and has no sense of humor nor sarcasm.
You and Fraudstein are off your games and are having a BAD day!!