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Ummm. Anavex hasn't submitted an NDA to the FDA for anything....yet.
I don't think Anavex has submitted it MAA yet. Submission of the MAA is what starts that clock.
As I understand it the EMA is now starting its end of the process where it appoints SMEs to examine the MAA once it is submitted. The EMA time frame for this stage of the process is 7 months.
As I understand the EMA procedure Anavex can't submit the MAA for 7 months after the letter.
Don't know about that. There is plenty of time to buy back before Feb'ish.
George, turns out you are right. This year the last day for tax loss selling is Friday Dec 29th because the market is closed on the 30th and 31st.
Sorry George you got that one wrong.
Your post has very little relationship to the real world.
The simple minded view you have of the process doesn't seem to include the P1, P2, P3 trials, meetings with regulators etc. The process is much more than filing an NDA. The NDA is a step very close to the end of the process.
They didn't. Biogen did multiple trials, submitted an NDA and that NDA took about the average amount of time to gain approval.
You can argue that the drug should have been approved or not, but Bigen went through the same process that Anavex is currently going through.
It's not like you can pop down to the 7-11 and pick up an NDA.
There is a process that has to be gone through. It's a long and carefully structured process designed to protect the public from drugs that don't work or have a bad side effect to benefit ratio.
All the things you list are part of the process.
Yeah I get that it takes a long time. I, like most others, would like the process to go faster.
Keep telling yourself that.
Totally worthless post.
It is certainly possible although Anavex has not released any information on that.
It is important to understand that rolling review does not shorten the time for approval. The 6 months clock for an FDA decision doesn't start until the last section of the NDA is submitted. What rolling review does is allow the FDA to examine the submitted sections and determine if there are any questions or requests for additional information concerning the submitted sections. Ordinarily such requests or questions would add time to the 6 month decision clock. So getting those issues, if there are any, out of the way before the 6 month clock starts keeps the 6 month timeline intact.
No. That should have been caught by the central CRO when it is compiling the trial results and locking the data base.
What he is missing is that same argument applies to the placebo group. Which explains one of the reasons that placebo groups are utilized. They wash out such effects in the statistical analysis.
That was a pretty lame argument.
As I understand it that would be a board of directors decision. The BOD could accept the bid, reject the bid, or choose to put it to a shareholder vote.
Anavex has sufficient takeover defenses in place to prevent that scenario.
At worst I think that would start a bidding war. Anavex has the ability to delay any takeover long enough for Rett to be approved and at that point $35/sh would not be a viable bid.
The FDA was the one dictating the adult trial. I do not think Anavex had a choice in the matter.
Independent... Well, they are separate trials with different trial population selections criteria.
They are the same drug treating the same disease, just in different age groups.
The FDA treats drugs for children with different standards for safety than it does for adults. Children are treated differently because they are still developing and growing so they have more opportunities for things to go wrong.
Since you or I haven't seen the full data you or I don't KNOW if the endpoints were met or not. The company has said the endpoints were met. Clear cut has no particular meaning in this case. The outcome is binary. The endpoints were met or they weren't.
If you want to say the data didn't exceed the endpoints, that's fine. However I suggest you wait till all the data is available before making that statement.
Most likely because the FDA suggested that the Pediatric trail be completed so the drug can be labeled for children as well as adults.
Why go through the approval process twice?
The people with Rett that 2-73 can help the most are the very young.
So sure of yourself based on speculation.
If there are not any more of the catalysts announced before Dec 31st there will be a lot of wailing and gnashing of teeth. I will be one of those bitching about Missling at that point.
True that there have not been MS trials of 2-73. If fact 2-73 has not been approved for anything as of now.
That is not to suggest that 2-73 won't ever be approved for an indication. Once it is approved for one indication that opens the door for additional trials for other indications.
Missling is building a moat around 2-73 so that if it does turn out to be a "wide spectrum" CNS drug Anavex will have strong protections to move forward.
Go to clinicaltrials.gov and read the exclusion criteria for each trial.
Looks more like the sign of a long term investor rather than a trader.
There are some of us here that have long term core holdings and a smaller portion of trading shares. When there is a serious possibility of positive news, the trading shares become holding shares till the situation becomes clearer.
Turns out there is more than one investing/trading strategy that works. Ask leo about how he approaches Anavex.
Biogen may have thought that they could pick up the molecule cheap when Anavex went BK as so many developmental bio techs do.
Perhaps Missling wanted more for the drug access than Biogen was willing to pay, or they may not have thought 2-73 didn't have enough MS potential.
We won't have any insight into that unless Anavex runs a MS trial and we see how the results turn out.
AFAIK there haven't been any 2-73 trials on humans for MS. In vitro tests done. I don't recall if there were murine tests on the MS model or not. Falconer might know that.
The more appropriate wording would be "hasn't yet gotten an NDA". The MAA process has started.
We don't know where Rett is in the NDA process.
Love your choice of words, "scrape by." What an emotionally loaded descriptor of the situation. AD approval is a binary event. There is no "scrape by."
I suggest you take this discussion to the SAVA board unless you are suggesting Missling pursue a similar strategy.
No matter how you slice it, the company has made significant progress and is close to having multiple NDAs filed.
How soon the Rett NDA will be filed is unknown to us but it can't be very long.
And for some posters dissing Misslling, no matter what he accomplishes, is better than admitting the company is set up for success.
All this arguing and no comment on the big move in the share price today on high volume. Hmmmm.
I have heard that you and the Christmas goose have something in common.
Bitch bitch bitch. No one thought the P2a was going to sufficient to get an approval.
Either Missling has found an incredible selection of desperate people in need of a pay check or he is putting together are very accomplished staff.
I think I'll go with accomplished.
You are going to be disappointed unless you are thinking of Christmas 2025.
Thanks for that tid bit of information. I was un aware of that.
That does indicate that the EMA may have had more information than I thought available to it when it made its recommendation to file an MAA.
Another positive piece of information in the mix.
No idea. I have no feel for how often the site CRO's forward the intermediate data back to the central CRO and then on to the company.