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0.05 significant level for each co-primary endpoint is what the article you referenced listed (3rd paragraph down from the top).
A significance value (p) is specified to establish statistical significance for a one tailed test. I've done a bit of research on this and found that typically the significance value used is 0.1, 0.05, or 0.01, with 0.05 the most common. I believe Anavex used 0.05. However, Doc328, wrote in his posts #391601 and #391539, that Anavex should have used 0.025 for a one tailed test. Could someone answer confidently which significance value Anavex should have used?
Who did the statistical analysis, Ariana?
Beware of a bull trap. Never buy a stock when its trend is down (esp when sector and market headed in same direction and recession is nigh)
Doc said FDA will want a larger Ph3 trial for Alzheimers if this one looks good.
I'm left confused by that statement
Unbelievable. If the bear market lasts thru 2023 maybe it doesn't matter much. Better to release results, if good, when the market is on the upswing. Hopefully Excellence has less ambiguous results than Avatar and the PDD trial. The theme song for all the AVXL long investors should be "As Time Goes By". What a tease this stock is.
Could go lower than that because we're sliding into recession, inflation, russia, the Fed meddling, biotech and Alzheimers stocks fallen out of favor for now, etc. That BS be going on til eoy at least.
Rett catalyst in the offing?
Could you provide a link to the conference's website? Is it one of the biggest PD conferences of the year? What is the full name of the conference?
If Avatar is not sufficient, why didn't FDA ask for more subjects enrolled into the trial?
Missing said Anavex gonna bring 2-73 home for Rett "very soon". Very soon, even on Missling time, isn't a year from now.
Of course they didn't outright say that; however, I bet their talks centered around what it would take to get 2-73 approved. Did FDA come right and say that? Of course not, but that was the unspoken point of the discussions. Huge unmet need for Rett. We're just talking bout getting approval for adults only in short term. Bar is set super low. Most importantly, the drug appears to be tolerated well. Why did Anavex bother to change trial to Ph3 if not to seek approval now? We all know why they did it ;) Missling said they're very close to bringing it home for Rett.
From the CC Wednesday:
FDA guidance told Anavex if wanna get Rett approval after Avatar then change Avatar to a Ph3 and use RSBQ-AUC. Why change to Ph3 if no plans to get approval? That's an indication to me. Anavex wanna get this done now to steal Trofenitide's thunder. Anavex also have fast track and bunch of other designations from FDA. They <3 Anavex :) Anavex has complied w/their requests for adult approval now and child approval at eoy or early next year.
Expanded Access is to generate buzz within Rett community and to get them talking about it and subsequently pressuring FDA to approve. The more people in it experiencing benefit, the more FDA will take notice and be influenced. Once approval overseas, that will also pressure FDA, rather than making American patients waiting additional years to see it approved.
No doubt. IR's inbox should be flooded. Inhibitory effect of GABA on neurons I suspect might help w/seizures and repetitive movements. Possibly w/constipation, breathing, etc. Once Anavex finally crosses the goal line for a disease, that will go a long way towards legitimizing the company and delegitimizing Feurstein and the critics. The sooner the better! Lets get this fast tracked! I hope Rett community will petition the FDA same way Alzheimers community did for Aduhelm (I miss saying Aducanumab :( Lol
Biomarkers and physical changes? GABA, EP's, seizures, etc. Wish we had tracked EP's. Like to hear the doctors on our Ph3 results at 30mg higher dose
I think they probably changed to anchored RSBQ and Ph3 b/c they felt it would most satisfy the FDA, thus facilitating approval ASAP. #occamsrazor
TY. Very impressive that Avatar bested Lavender considering that the subjects were much older and their disease much further progressed. That's like subjects with moderate Alzheimers besting those w/MCI in drug trials. Impressive! AND the subjects didn't experience the prominent diarrhea and vomiting the Lavender girls did. Those side effects wreck havoc on their already disrupted GI tracts and may lead to malnutrition, weight loss, esophageal erosion, dental caries, insomnia, further mental stress, exhaustion, soiled nappies, filthy bums and vomit strewn about for caregivers to cleanup (gross). Those severe side effects take a toll over time on subjects and caregivers. Probably necessitating having to take a pill just to deal w/the side effects, or eventually needing to discontinue Trofinetide.
Doc I fear is stuck in the past and thinks the FDA operates the same way it did back in the 1980's. This is the 2020's and the FDA aims to be more efficient and expedite drugs to market, especially for diseases w/unmet need. I think Excellence won't be need. Anavex changed that Avatar to a Ph3 trial for a reason, which is fast track to approval.
You're not distinguishing between Rett in girls and Rett in women, big difference. Incidence in women is probably less and harder to recruit women than girls. To get approved for women shouldn't take as many subjects vs approval for girls.
Two successful Rett trials. Anavex is 2 for 2! Everybody knows 2-73 is the $hit! #winning
rettsyndrome.org and Rett advocacy groups are advertising the Avatar trial was a success, so that should help recruitment for Excellence
So what do you propose should be tested? Seizures? Anavex did that. I thought FDA wanted these endpoints? They are non communicative so a cognitive test like adas cog would be tough.
Took over year to enroll just 36. To enroll hundreds would take years. There aren't that many Rett women and their caregivers are reluctant to enroll them in a trial.
FDA didn't just approve the changes, it is my understanding they requested, or suggested, the changes.
Doc328 said 6-7 years for AD completion. AD will require another, much larger Ph3 trial according to Doc. He says 2 years for Rett Excellence results.
Why do you correlate the XBI and IBB biotech etf's with AVXL and not the pharma etf's, such as IHE and PPH?
Anavex, technically speaking, *should* belong to the pharma industry and not biotech, however, it does seem to track the biotech etf's more closely for whatever reason.
TY for letting us know Avatar top line results won't be announced this week. I wait for SP to drop a bunch more before adding to my position.
Biotech is still bearish.
I hope Anavex investors let Anavex IR know about this and encourage Anavex to study it inside and out to take full advantage. Hope the advocacy/support groups for the different neuro diseases inform their members about it.
Your anti 'Big Gubmint' bias blinds you. Government has done huge things. Much of our drug development is born in govt labs or funded by govt. That act is huge. Patients and advocates for ALS know this
The act doesn't just apply to ALS. People don't fully understand the act, its scope, and implications for all neuro disease patients.
I believe this act is significant, not just for ALS patients, but for patients w/other serious neurological diseases as well. Patients I've followed for many years that have ALS say this act is a big deal. I hope Missling is aware of it and takes full advantage. I'll be contacting IR to let them know to get on it.
The Accelerating Access to Critical Therapies for ALS Act was signed into being by Biden yesterday. How significant is this act for Anavex? Any relevance and will it improve early access to Anavex's pipeline for all patients w/serious neurological diseases?
Thanks for nothing Lol
Wall St. isn't sinking $ into into biotech right now. In case you haven't noticed, sector is in a bear market