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Perhaps Anavex was waiting for this before starting its PD trial.
He's not an American lawyer, but he thinks he knows the Federal Rules of Civil Procedure.
It's always amusing to see someone declare war on a fact.
You are giving too much credence to the filing of a complaint. Anyone can file a complaint, even if there is no case. A complaint has to survive a motion to dismiss or a motion for summary judgment before it has any meaning.
Keep in mind that lawsuit is bogus and not the result of any actionable misconduct by Anavex.
I didn't realize that Missling had Sanofi's level of resources and expertise.
He will probably PR the filing upon the EMA accepting it.
The 3-71 Phase 2 protocol, from my lay perspective, seems incredibly comprehensive and complex.
When I was in Copenhagen some years ago, I went looking for a Danish pastry, but all they had were simply pastries. Seems wrong, even if the pastry I found was the size of a large plate.
What is it with you people's obsession with hair length?
You all sound like, "Damn hippies, get off my lawn!"
It's the FDA's new draft guidance that claims the ADL endpoint has little utility for our tested population, and that's what counts.
If that's your concern, 2-73 has a long term safety record. But you had already discussed safety as a separate concern, so it looks like you are double counting it.
Regulators are fair to all parties by holding them to the same endpoints and the same p value requirements. The size of a trial is not part of a fairness requirement. (Companies running smaller trials have a steeper hill to climb to achieve p values, so they have to overcome a statistical disadvantage as the price of the smaller trial.)
This is far from a hyper inflationary environment.
The current ~83 percent EMA approval rate is real -- not imagined or arbitrary -- but it represents an outsider's view of the chances of success of a submitted MAA. That is to say, it is a necessary generalization; it is only the best available information we third parties have.
To do better, to become a reliable drug-specific application predictor, you would need an insider's view of an application and the agency's internal process and values. (Think of the view that Kun Jin previously had at the FDA for AD NDAs.) You would need available to you (1) all the data being provided to the EMA (including the applicant's responsiveness to pre-submittal conversations), and (2) the EMA's both public and unpublished priorities, preferences, and values.
As an outsider, as we are, you do not have access to this information. Very few people will have the insider's view, and all of them will be application reviewers associated with the EMA. So the trap to be avoided is assuming that your assumptions about the entirety of the data and internal EMA practices are correct when, in fact, you are just projecting your opinions on the event and declaring them as facts.
It's fine to label these thoughts as opinions. But they aren't facts. Limited as the 83 percent generalization is, it remains the most significant, publicly available relevant fact. Your necessarily uninformed opinion on case-specific MAA odds is not a fact.
I don't buy the argument that any upcoming good news, or confirmation of prior good news, has been priced into this unregarded stock. At some point the value of 2-73 will be recognized, but that day has not yet come.
I believe Missling made a reference to the peer review being published in one of the six leading AD journals. That sounded middling to me.
"Being wrong is not corruption."
I think you are on to something.
Your guy's 2024 predictions haven't aged well.
Hahahahaha.
The larger shareholders are not voting like the smaller shareholders.
It stops when you wear a mask in crowded, small places.
I was responding to the information in powerwalker's link to the Alzheimer's Today article, which described an amyloid MOA, and did not go to the poster. I think it's a stretch to say that confirms a bias.
Correction, should be "side effect."
The MOA for this drug falls within the amyloid thesis, which should cap its long term effects going forward.
By the way, "poisoning" is a side affect? What does that mean?
It's a larger than usual revision from the preliminary jobs number, but there are always revisions, both up and down. Still leaves a good number for the economy.
We know from various studies that the normal brain atrophy rate in health individuals of comparable age is ~0.5 percent annually, which is not much different than the treated arm's ~0.75 percent rate reported by Anavex in the AD 2b/3. What we don't know is what the brain atrophy rate might be among healthy elderly treated with blarcamesine and whether it would fall under the 0.5 percent mark. That figure would directly address Karlchen's question.
You know, this exchange just started with what you eventually described as a "brain fart," and what I immediately described, accurately, as a confused analogy.
Rather than just conceding this and correcting yourself like a good faith poster, you have gone out of your way to attack me in three consecutive posts for having the temerity of pointing out your error. This is typical behavior from you, unfortunately, and helps explain your reputation here. Again.
My excuse was taking your post seriously.
Do you know the difference between a plaintiff and a defendant? Do you know that a defendant doesn't initiate a case?
Yes, I'm a lawyer, but you shouldn't have to be a lawyer to know these things.
Regarding gray matter loss changes -- no healthy people were tested, so you can't make inferences about them.
Your analogy is confused. Plaintiff/not innocent/great case is not a set. A plaintiff with a great case is not establishing innocence.
That's undocumented.
The fact that they have not announced further efforts with Rett does not mean they aren't working on trial design, siting, and recruitment of staff.
Why should we pay attention to Drs. Hagerman or Sabbagh when we have access to the anonymous message board posters doc328 and Investor2014, who obviously know so much more and whose wild accusations against the CEO are so much more persuasive?
The chance of you being paid to post negatively here is infinitely higher than the chance I am being paid to post here.
Hosai,
The FDA has clearly signaled they want trial results with at least 100 dosed arm completers. I have not seen anyone post an example of the FDA rejecting an NDA based on some specific dropout rate if the 100 dosed completer arm is present. (Nor have I seen anyone post an example of a clinical trial result rejected by the FDA because a message board poster accused the CEO of being a lying psychopath.)
As a point of clarification, did 2-73 meet this 100 person dosed completer threshold in the AD 2b/3?
Did 2-73 alternatively meet its AD 2b/3 endpoints through achieving a p value under .025 in both ADAS-Cog and CDR-SB?
Did 2-73 achieve the singular endpoint of ADAS-Cog in the AD 2b/3 with a p value of less than .05 in line with the recently issued FDA draft guidance?
Has Anavex ever reported any serious safety concern regarding the administration of 2-73 to a variety of age groups, including both geriatric and pediatric patients, and specifically in the AD 2b/3?
Has Anavex reported statistically strongly significant results in the AD 2b/3 unprecedentedly demonstrating the retention of grey brain matter?
Has Anavex reported in the AD 2b/3 statistically significant, favorable outcomes in AB 42/40 blood plasma ratio?
Has Anavex received a green light from the EMA to submit an MAA without recourse to a follow up trial?
Thanks.
Again, the draft FDA AD trial guidance is prospective, as it would address FDA actions going forward. Agency guidances govern how the agency does its business. In this case, it could apply only to approval decisions which have not yet occurred.
A more reasonable question would be whether changed guidance could be retroactively applied to earlier denials for failure to achieve the ADL endpoint. (The answer is No: Agency decisional guidances and rules in effect at the time of the decision are applied, even if they are later changed.)