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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.
Is there 72ish data?
All in all I thought it was a pretty positive article about Anavex's finances.
The "two negatives" hinted at, at the end of the article, were designed to generate traffic to their website.
Consider the average daily volume. Then ask yourself how much impact a few independent bashers on a message board can have on that volume?
I get that the impact bashers can have is on the margins and that few cents on the margins can be profitable if you are a good trader.
AVXL chart most often mirrors the XBI chart is shape, plus or minus the Beta. That to me suggests that the bashers and pumpers have less effect than the overall market.
On those times where it does seem that the share price is being manipulated, it seems to me to be the shorts doing their thing. The short position is worth many 10s of millions of Dollars. It seems more likely to me that the people doing the shorting have large sums of money available to use in affecting the share price. They have far more impact than a few message board bashers or pumpers and they know how to use careful trading to affect the direction of the share price.
My opinion on that.
The way you phrased your question assumes that another P3 is required. Some people on the board think that is the case, others do not.
Either way, strong OLE data will be a positive in considering a drug application, especially the longer term 96 week OLE data. In general OLE data is not considered as strong as data from a random controlled trial.
Based on the "encouragement" from the EMA to file the MAA one might conclude that the data they saw was sufficient. Conversely the EMA may have seen the 48 week data and said it looks good so far but the 96 week data is what we really want to see, so make sure to include that in your MAA.
For me, I just accept that the process has started, the initial pass at the data was enough for the EMA to say go forward. Beyond that we really don't know much more. I am comfortable with the uncertainty.
As I understand the SEC thoughts on material events filing an NDA would not be a material event. Filing of an NDA does not obligate funds or result in significant income. The outcome of an NDA filing is not known at the time of filing. Having said that, most companies will choose to PR an NDA filing.
The FDA decision to approve or deny the NDA is a material event. If approved there is an expectation of significant revenues, if disapproved it means the impairment of the investment to develop the drug which is likely to be significant.
Material events according to the SEC examples.
I think you will see the share price do the most responding on the news the NDA is approved. Which is not to say there won't be a share price response when the NDA is filed. I'm pretty sure there will be.
I agree that the positive feedback from the EMA is encouraging. Actually filing the MAA is the important step. While most expect Anavex to file the MAA as soon as the EMA process permits, Anavex has a long history of not meeting expectations. I will be relieved when Anavex announces actual MAA/NDA filings.
Given the difference in time frames for the approval processes in the different countries it is quite possible that the FDA will rule on the Anavex AD NDA before the EMA.
The TGA process is faster than the EMA process so if Anavex files in AU that also could come faster than the EMA.
Seems to me that the Rett NDA is going to set the time frame for the US AD NDA.
There has been no application to the EMA. There has been a letter of intent to file an application. That application will not be filed for another 6 months of so unless the EMA indicated that Anavex can file sooner.
Yes it is voluntary task.
Alas, As a mod I have to read all the posts. Back when Mods had no ability to delete anything I was able to use ignore. Now that the rules have changed again I'm back to reading everything.
That law has not been tested in the courts. The first time it is used there will be a law suit to determine its legitimacy.
You want to support that accusation?
Why would any company want to "partner" with governments?
This isn't the Covid crisis. There isn't an unending stream of money being thrown at AD.
Partnering with governments would cede way too much control away from Anavex.
This is a bad idea.
Someday is sooner than some think.
I have to agree that most of the time the shape of the AVXL curve matches XBI with the AVXL curve having a beta of close to 2X.
Anchor your graphs at Monday 2 weeks ago and it shows AVXL about double the gains of XBI.
No one has mentioned what you alluded to, Missling has taken Anavex through the valley of death where many developmental companies succumb.
Most developmental company CEOs would be ecstatic to have $150 million in the bank
Next short interest report is Dec 11 after the close.